Contraception - Articles in Press

Fatal flaws in a recent meta-analysis on abortion and mental health - Corrected Proof

Julia R. Steinberg, James Trussell, Kelli S. Hall, Kate Guthrie — 2012-05-14

Abstract: Similar to other reviews within the last 4 years, a thorough review by the Royal College of Psychiatrists, published in December 2011, found that compared to delivery of an unintended pregnancy, abortion does not increase women's risk of mental health problems. In contrast, a meta-analysis published in September 2011 concluded that abortion increases women's risk of mental health problems by 81% and that 10% of mental health problems are attributable to abortions. Like others, we strongly question the quality of this meta-analysis and its conclusions. Here we detail seven errors of this meta-analysis and three significant shortcomings of the included studies because policy, practice and the public have been misinformed. These errors and shortcomings render the meta-analysis' conclusions invalid.

Reproductive factors in relation to ovarian cancer: a case–control study in Northern Vietnam - Corrected Proof

2012-05-14

Abstract: Background: Ovarian cancer, one of the most common cancers in women and the most serious gynecologic cancer, is known to be influenced by reproductive factors, but these factors have not previously been examined in Vietnamese women.Study Design: We analyzed 262 ovarian cancer patients recruited from 27 hospitals in 12 provinces and Ha Noi City from April 2001 to May 2006, plus 755 controls matched by age and residential address.Results: The risk of ovarian cancer was significantly lower in parous women than nulliparous women. Use of an intrauterine contraceptive device was also associated with a reduced risk. In contrast, induced abortion, late menopause and years of ovulation were significantly associated with an increased risk of cancer.Conclusions: Parity and intrauterine device use were associated with a reduced risk of ovarian cancer in Vietnamese women, whereas induced abortion, late menopause and years of ovulation were associated with an increased risk.

Ob/Gyn training in abortion care: results from a national survey - Corrected Proof

Courtney B. Jackson, Angel M. Foster — 2012-05-07

Abstract: Background: Abortion is one of the most common health services utilized by women in the USA. Training new providers is an important factor in ensuring an adequate supply of clinicians to provide comprehensive reproductive health services.Study Design: Data came from a mailed survey of obstetrician/gynecologists who completed residency in 2007.Results: Participation in first-trimester procedures training was lower than that in second-trimester procedures training. Notably, residents reported less exposure to medication abortion than nearly all other abortion procedures; only 41% of survey participants reported having received training in mifepristone/misoprostol. Significantly more respondents who trained in programs with routine training participated in first-trimester procedures, specifically medication abortion, manual vacuum aspiration and electric vacuum aspiration, compared to those who attended programs with elective training.Discussion: As the vast majority of abortions in the USA occur during the first trimester, exposure to the full array of common first-trimester abortion procedures, including both medication abortion and aspiration abortion procedures, warrants attention. These findings suggest that residency education guidelines may need to be revised to ensure adequate training in medication abortion.

Adolescent experience with intrauterine device insertion and use: a retrospective cohort study - Corrected Proof

Lisa L. Bayer, Jeffrey T. Jensen, Hong Li, Mark D. Nichols, Paula H. Bednarek — 2012-05-07

Abstract: Background: Adolescents contribute disproportionately to the epidemic level of unintended pregnancy in the USA. Intrauterine devices (IUDs) are highly effective but underutilized in this age group.Study Design: We searched our electronic clinic database to identify females ≤19 years old who underwent attempted IUD insertion between January 2007 and June 2009. This retrospective cohort study primarily compared the insertion and postinsertion experiences between nulliparous and parous teens.Results: Of the 307 charts reviewed, the majority of subjects were white (73.4%) and nulliparous (77.5%), with a median age of 18 years (range 15–19). The vast majority (96.4%, 296/307) had a successful IUD insertion upon first attempt; all of the 11 unsuccessful IUD insertion attempts were among nulliparous teens.Follow-up was available for 56% (172/307). During the first 12 months of use, there were 2.9% (5/172) IUD expulsions and 24.4% (42/172) removals, with no differences between nulliparous and parous teens. IUD continuation at 6 months was 83.3%. Pelvic inflammatory disease was diagnosed in 4.6% (8/172) of post-IUD insertions. There were no pregnancies reported in those teens with IUD continuation, while six were reported in subjects who underwent IUD removal. Independent predictors of IUD discontinuation were a history of chronic pelvic pain or dysmenorrhea, and bleeding and/or pain complaints at any post-IUD visit.Conclusions: Overall, adolescents experience minimal complications with IUD use, with similar rates of successful insertion as adults. IUD discontinuation rates were not significantly different between nulliparous and parous teens. While discontinuation was higher than reported in adults, it was lower than reported among teens using other forms of contraception.

Eliminating the routine postoperative surgical abortion visit - Corrected Proof

Mary Gatter, Nitzan Roth, Catherin Safarian, Deborah Nucatola — 2012-05-04

Abstract: Background: The objective of this study was to determine whether replacing the “routine” postoperative visit after surgical abortion with an “as indicated” visit is associated with an increase in the rates of either failed abortion (continuing pregnancy) or repeat abortion.Methods: We compared the rate of continuing pregnancy in 50,702 first-trimester surgical abortion patients who were offered routine postoperative visits in one time period (1/1/00–4/30/07) to the rate in 20,315 first-trimester surgical abortion patients from a later time period (5/1/07–12/31/09) in which routine postoperative visits had been discontinued. We also compared the rate of repeat abortion within 1 year of the initial procedure for both first- and second-trimester surgical abortion patients for the same time periods.Results: The rate of continuing pregnancy remained stable before and after routine visits were discontinued (39.4 per 100,000 first-trimester surgical abortions for each group).The rate of repeat abortion within 1 year after the initial procedure was lower after routine visits were discontinued (8.2%) than before routine visits were discontinued (8.7%), p=.007.Conclusion: We conclude that elimination of the routine postoperative visit after a surgical abortion and the substitution of an “as indicated” postoperative visit are not associated with an increase in either continuing pregnancies or repeat abortion.

Race, reproductive politics and reproductive health care in the contemporary United States - Corrected Proof

Carole Joffe, Willie J. Parker — 2012-05-04

To paraphrase Leo Tolstoy, who famously wrote that all unhappy families are unhappy in their own way, we can say that all nations confront the thorny issue of demographics, but each in its own, typically controversial, way. Various European countries, for example, have anxieties about a “demographic winter,” which is a below replacement birth rate of the native population, which has led to corresponding fears about rising birth rates among Muslim immigrants. China, driven by worries about overpopulation, has instituted coercive reproductive policies that many observers find unacceptably harsh. The United States, a country marked by extreme stratification on both racial and economic grounds, is a particularly interesting case to consider from a demographic lens because there has been a history both of targeting the birth rates of people of color and at the same time deep political divisions about the provision of reproductive health services — particularly abortion but increasingly, as the current election season reveals, contraception as well.

Controversies in family planning: arteriovenous malformation - Corrected Proof

Jennefer A. Russo, Laura Gil, Teresa DePiñeres — 2012-05-04

JG is a 25-year-old G2P0 female with one previous uneventful medical abortion in October 2008 and no live children. In December 2009, she was admitted to a hospital with a first episode of severe vaginal bleeding. An arteriovenous malformation (AVM) was suspected on a vaginal ultrasound and was confirmed by Doppler ultrasound and an MRI. These studies demonstrated a dilated vessel arising from the left uterine artery, reaching almost to the endometrial surface and ending as a cystic 15-mm formation with demonstrable internal flow (). The hemorrhage stopped spontaneously and no treatment was initiated. She had a second episode of bleeding in April which again stopped by itself. No transfusions were needed but her hemoglobin dropped to 9 mg/mL each time. Apart from these two episodes, her menses remained regular and normal in quantity.

Drospirenone and levonorgestrel in combination with either 30 or 20 mcg ethinylestradiol reduce soluble adhesion molecules in Brazilian women; cross-sectional study - Corrected Proof

2012-05-04

Abstract: Background: The objective of this study was to evaluate the effect of three contraceptive pills containing ethinylestradiol (EE) (20 or 30 mcg) in combination with drospirenone (DRSP) and levonorgestrel (LNG) on plasma concentration of adhesion molecules vascular cell adhesion molecule -1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1) and E-selectin.Study Design: A cross-sectional study was conducted with 72 participants (18–30 years old) distributed into three groups that used oral contraceptives containing EE 20 or 30 mcg combined with DRSP 3 mg or EE 30 mcg/LNG 150 mcg for at least 6 months. The control group was comprised of nonusers of contraceptives. Soluble VCAM-1, soluble ICAM-1 and soluble E-selectin were evaluated by enzyme-linked immunosorbent assay.Results: Compared to the control group, a significant decrease was found in VCAM-1 and ICAM-1 concentrations with use of DRSP/20 EE and LNG/30 EE.Conclusions: DRSP/20 EE and LNG/30 EE induce favorable changes in endothelial function.

Hormonal contraception and HIV acquisition risk: implications for individual users and public policies - Corrected Proof

Anrudh K. Jain — 2012-04-30

Abstract: Background: A recent observational study among HIV-1 serodiscordant couples (uninfected women living with an infected partner) raised concerns about the safety of injectable contraceptives, especially depot medroxyprogesterone acetate (DMPA). The purpose of this paper is to assess the implications of potentially elevated risk of Human Immunodeficiency Virus (HIV) acquisition with the use of hormonal contraceptives for individual users and public policies.Study Design: Two indicators expressing costs (additional unwanted births and additional maternal deaths) in terms of the same unit of benefit (per 100 HIV infections averted) are estimated by using data on competing risks of unwanted birth and HIV acquisition associated with the use of various contraceptive methods. Elevated HIV acquisition risks associated with hormonal contraception observed in the observational studies of family planning users, sex workers and HIV-1 serodiscordant couples are used. Other relevant data for Kenya, South Africa and Zimbabwe are used to illustrate the potential effect of withdrawal of DMPA at the population level.Results: Both the risks of unwanted birth and HIV acquisition with sterilization, intrauterine devices (IUDs) and implants at the individual level are lower than those with DMPA. A shift from DMPA to an oral contraceptive (OC) or male condom by an individual could result in about 600 and a shift to no method in about 5400 additional unwanted births per 100 HIV infections averted. At the population level, the withdrawal of DMPA from Kenya, for example, could result in 7600 annual additional unwanted births and 40 annual additional maternal deaths per 100 HIV infections averted.Conclusion: Individual DMPA users may be advised to shift to sterilization, IUD or implant depending upon their reproductive needs and circumstances, but not to no method, OC or even condom alone. At the macro level, the decision to withdraw DMPA from family planning programs in sub-Saharan Africa is not warranted.

Multi-specialty family planning training: collaborating to meet the needs of women - Corrected Proof

Jody Steinauer, Christine Dehlendorf, Kevin Grumbach, Uta Landy, Philip Darney — 2012-04-25

The specialty of family medicine is recognized as having an important role in the delivery of family planning services in the United States. Not only do many women receive their contraceptive services from family physicians , but there is a growing recognition of the role family physicians can play in ensuring that women have access to safe and timely abortion service . Passage of the Affordable Care Act has drawn attention to this role, as increased insurance coverage may result in many women accessing contraceptive care within primary care services, as opposed to using dedicated family planning clinics.

Post-ovulatory administration of levonorgestrel: interference with implantation is not excluded - Corrected Proof

2012-04-25

In their work, “Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation,” Noè et al. misleadingly wrote that their results are incompatible with the inhibition of implantation by post-coital levonorgestrel (pcLNG). According to their data, pcLNG was 100% effective when administered during the pre-ovulatory phase; conversely, the post-ovulatory administration of pcLNG to 45 women resulted in 8 pregnancies instead of the expected 8.7, a statistically insignificant difference. Unfortunately, the authors made two mistakes:

Response to Letter to the Editor - Corrected Proof

Gabriela Noe, Horacio B. Croxatto — 2012-04-25

We thank Puccetti et al. for their interest in our recent article on levonorgestrel emergency contraception (LNG-EC) . They state that we made two mistakes. Our study assessed the ability of levonorgestrel used as in emergency contraception (LNG-EC) to prevent clinical pregnancy, not conceptions.

Effect of letrozole on uterine tonus and contractility: A randomized controlled trial - Corrected Proof

Helena Kopp Kallner, Pak Chung Ho, Kristina Gemzell-Danielsson — 2012-04-23

Abstract: Background: Letrozole inhibits estrogen production. It has been shown to increase efficacy in medical abortion when used with misoprostol. This study investigated if letrozole acts as an abortifacient due to a synergistic effect with misoprostol on uterine contractility.Study Design: Sixteen healthy women requesting surgical abortion were randomized to receive either no pretreatment or treatment with letrozole 7.5 mg daily for 3 days prior to the abortion. All women received misoprostol 400 mcg vaginally 3.5 h prior to surgery. Intrauterine pressure was measured for 30 min before and 3.5 h after misoprostol was given using an intrauterine pressure catheter. Main outcome measure was uterine contractility analyzed by repeated-measures analysis of variance.Results: At baseline, uterine contractions were absent and tonus was low. No significant difference was seen between the two groups in tonus (p=.818) or in contractility (p=.423) after misoprostol administration.Conclusion: Letrozole does not appear to act as an abortifacient through an effect on uterine contractility or increased sensitivity to misoprostol of the uterine myometrium.

Effects of hormonal contraception on vaginal flora - Corrected Proof

2012-04-23

Abstract: Background: The sector of the market that deals with contraception offers a long list of different contraceptive methods. Within the estroprogestinic choice, the routes of administration are oral, transdermic and vaginal one. Even though efficacy is comparable with these methods, secondary and adverse effects are directly involved in the acceptability of the method.Study Design: This was a prospective comparative study. During 1 year, we enrolled 60 asymptomatic women who voluntarily requested combined oral contraception (COC) or combined contraceptive vaginal ring (CCVR group). After a baseline study of vaginal milieu prior to starting hormonal contraception, we performed a follow-up. For each woman, we examined vaginal pH; quantification of leukocytes, lactobacilli, Candida and cocci on saline microscopy fluid; Gram stain with Nugent score and the presence of vaginal infection [culture for Trichomonas vaginalis, albicans and nonalbicans Candida, Group B Streptococcus (GBS)].Results: At the end of follow-up, there was a little change of vaginal milieu in both groups. We noted an increase of lactobacilli in the CCVR users and an increase of GBS in COC users.Conclusion: CCVR compared to COC users showed an increase of the number of lactobacilli in vaginal flora. It means that an increase of leukorrhea in that group could be protective in terms of prevention of vaginal imbalance/infection.

Tubal sterilization during cesarean section or as an elective procedure? Effect on the ovarian reserve - Corrected Proof

2012-04-23

Abstract: Background: The purpose of this study is to compare the effects of tubal sterilization on the ovarian reserve by means of hormonal and ultrasonographic evaluation during a cesarean section or when performed as a planned interval procedure.Study Design: Fifty women who had undergone tubal sterilization during a cesarean section (n=24) and by minilaparotomy as an elective procedure (n=26) were included in the study. Tubes were ligated with the Pomeroy technique in both groups. The women who had chosen to use barrier method or intrauterine device for contraception (n=30) constituted the control group. Among the women in the control group, two separate control groups were constituted (control 1 and control 2) who were age matched with the women in each study group. Hormone levels including antimüllerian hormone (AMH) and inhibin B and ultrasonographic evaluations were performed on the third day of the menstrual cycle 1 year after the tubal sterilization procedure.Results: Mean blood estradiol, follicle stimulating hormone and luteinizing hormone levels on the third day of the cycle postoperative 12 months after the surgical intervention did not show any significant differences in the groups with respect to their age-matched controls. There was no significant difference in terms of mean serum AMH and inhibin B levels between the groups and their age-matched controls. However, significantly higher postoperative levels of mean AMH levels were detected in the tubal sterilization during cesarean section group when compared with the minilaparotomy group, and significantly lower postoperative levels of mean inhibin B were detected in the elective tubal sterilization via minilaparotomy group when compared with the cesarean section group. Statistically significant differences were observed in terms of number of antral follicles and mean ovarian volumes being less in the elective tubal sterilization via minilaparotomy group when compared with age-matched controls.Conclusion: Intraoperative cesarean section tubal sterilization seems to be a practical and safe method, and has less effect on the ovarian reserve when compared with planned tubal sterilization by minilaparotomy.

Reproductive health preventive screening among clinic vs. over-the-counter oral contraceptive users - Corrected Proof

Kristine Hopkins, Daniel Grossman, Kari White, Jon Amastae, Joseph E. Potter — 2012-04-23

Abstract: Background: Interest is growing in moving oral contraceptives over-the-counter (OTC), although concerns exist about whether women would continue to get preventive health screening.Study Design: We recruited cohorts of US-resident women who obtained oral contraceptives from US family planning clinics (n=532) and OTC from pharmacies in Mexico (n=514) and interviewed them four times over 9 months. Based on self-reports of having a Pap smear within 3 years or ever having had a pelvic exam, clinical breast exam and testing for sexually transmitted infections (STIs), we assessed the prevalence of preventive screening using Poisson regression models.Results: The prevalence of screening was high for both groups (>88% for Pap smear, pelvic exam and clinical breast exam and >71% for STI screening), while the prevalence ratios for screening were higher for clinic users, even after multivariable adjustment.Conclusions: Results suggest that most women would obtain reproductive health preventive screening if oral contraceptives were available OTC, and also highlight the need to improve access to preventive screening for all low-income women.

Chronicity of partner violence, contraceptive patterns and pregnancy risk - Corrected Proof

2012-04-23

Abstract: Background: Partner violence may interfere with a woman's ability to maintain continuous contraception and therefore contribute to increased risk of pregnancy among childbearing women.Study design: A retrospective review of medical records (N=2000) was conducted from four family planning clinics in the northeast United States. Eligibility criteria for inclusion were as follows: (1) female, (2) reproductive age (menarche through menopause), (3) seeking reproductive services and (4) clinic visit for annual gynecologic exam between 2006 and 2011.Results: Partner violence was documented in 28.5% (n=569) of medical records. Chronicity of violence influenced contraceptive patterns and pregnancy risk. Women reporting past year partner violence only [odds ratio (OR)=10.2] and violence during the last 5 years (OR=10.6) had the highest odds of not using a current method of contraception. Women reporting recent exposure to violence were most likely to change birth control methods and use emergency contraception (OR=6.5). Women experiencing any history of violence reported more frequent contraceptive method changes during the previous year.Conclusions: A history of partner violence was common among women utilizing family planning services. The chronicity of violence appeared to play a significant role in contraceptive method changes, types of methods used and pregnancy risk. These results may be one explanation for increased pregnancies among women who experience partner violence.

Ultrasound-guided hysteroscopy to remove a levonorgestrel intrauterine system in early pregnancy - Corrected Proof

Elizabeth A. McCarthy, Nisha Jagasia, Peter Maher, Miranda Robinson — 2012-04-12

Abstract: Background: Correctly placed levonorgestrel-releasing intrauterine systems (LNG-IUSs) are rarely associated with intrauterine pregnancy when pregnancy occurs. LNG-IUS retrieval, termination of pregnancy and conservative management if retracted strings prevent ready removal are the usual clinical options given to women. The conservative course raises concerns about teratogenesis related to high local progestin exposure for the developing fetus.Study Design: This case report describes combined saline hysteroscopy and ultrasound to retrieve an LNG-IUS at less than 9 weeks of gestational age. A systematic review of the literature was performed to identify similar case reports by contacting the manufacturer and searching Pubmed from 1900 through November 2011 using the terms ((levonorgestrel AND intrauterine) OR mirena) AND (pregnan⁎ OR fetal OR fetus OR teratogen⁎) NOT (menorrhagia OR hyperplas⁎ OR ectopic OR malig⁎ OR cancer).Results: We identified 37 cases of LNG-IUS pregnancy exposures in the absence of spontaneous expulsion or myometrial or intraperitoneal placement of LNG-IUS. Given the presence of two congenital anomalies reported in the group, the anomaly rate is 5.4%, 95% confidence interval 0% to 11.5%.Conclusions: Intrauterine LNG-IUS exposure is associated with a low frequency of congenital anomalies. Combining hysteroscopy with ultrasound facilitates surgically precise LNG-IUS removal despite retracted strings.

Effect of vitamin E and C supplements on lipid peroxidation and GSH-dependent antioxidant enzyme status in the blood of women consuming oral contraceptives - Corrected Proof

Fatemeh Zal, Zohreh Mostafavi-Pour, Fatemeh Amini, Afrooz Heidari — 2012-04-11

Abstract: Background: Oral contraceptives (OCs) may affect oxidative stress status. We aimed to assess whether supplementation with vitamins E and C reduced this OC effect.Study Design: One hundred twenty healthy female individuals were divided into three groups: A, control; B, untreated OCU (OC users); and C, treated OCU (OC users with vitamin E and C supplementation). In all cases, plasma glutathione peroxidase (GPx) and glutathione reductase (GR) activities and malondialdehyde (MDA) level were determined.Results: Significant increases were found in the plasma MDA level, and activities of GPx and GR in plasma were decreased in Group B compared to the control group. Supplementation with vitamin C and E significantly increased the activity of GPx and GR activity, and reduced plasma MDA levels in Group C (p<.05).Conclusions: These data suggest that low-dose OCs, by enhancing the stress oxidative and lipid peroxidation, may represent a potential cardiovascular risk factor, and the use of vitamins E and C may be beneficial in ameliorating this side effect of OCs.

A combined oral contraceptive containing drospirenone changes neither endothelial function nor hemodynamic parameters in healthy young women: a prospective clinical trial - Corrected Proof

2012-04-05

Abstract: Background: Combined oral contraceptives (COCs) may lead to a rise in cardiovascular disease risk, possibly associated with changes in blood pressure and endothelial function.Study Design: The objective was to evaluate the impact of COC containing 20 mcg of ethinylestradiol (EE) and 3 mg of drospirenone (DRSP) on the arterial endothelial function, systolic and diastolic blood pressure (SBP and DBP , respectively), heart rate (HR), cardiac output (CO) and total peripheral resistance (TPR) of healthy young women. Of the 71 women in the study, 43 were evaluated before the introduction of COC and after 6 months of its use (case group) and 28, COC nonusers, were assessed for the same parameters at the same time interval (control group).Results: No significant changes in endothelium-dependent and endothelium-independent functions or in measures of SBP, DBP, HR, CO and TPR caused by COC use were observed in the case group (p>.05 for all variables) or in the control group.Conclusion: These data suggest COC with 20 mcg EE and 3 mg DRSP does not alter arterial endothelial function or hemodynamic parameters in healthy young women.

Trends in contraceptive patterns and behaviors during a period of fertility transition in China: 1988–2006 - Corrected Proof

2012-04-05

Abstract: Background: This paper explores how contraceptive patterns and behaviors changed during the course of China's population transition and a period of low fertility from 1988 to 2006.Study Design: Based on data from Chinese nationwide surveys of family planning and reproductive health undertaken in 1988, 1997, 2001 and 2006, this study uses a multinomial logit model to analyze changes in, regional differences in and determinants of contraceptive behaviors during this period.Results: The overall prevalence of contraceptive use among married women aged 15–49 years changed little during these 20 years, holding steady at about 90%. However, there were notable changes in the method mix: the predominant methods used were the long-term methods of the intrauterine device (IUD) and female sterilization, and contraceptive use gradually shifted from sterilization to IUDs and condoms. There existed a close relationship between contraceptive methods used and sociodemographic characteristics. Hans, rural, old and less educated women are more likely to use sterilization, while minorities, urban, young and educated women are more likely to use IUDs.Conclusion: There are marked changes in the method mix among different demographic groups during the course of China's population transition and a period of low fertility. The findings indicate that future works aimed at promoting reproductive health should be diverse among different populations.

Further evidence for lack of negative associations between hormonal contraception and mental health - Corrected Proof

Elena Toffol, Oskari Heikinheimo, Päivikki Koponen, Riitta Luoto, Timo Partonen — 2012-04-05

Abstract: Background: There is limited and inconsistent information concerning the effects of hormonal contraception [oral contraceptives (OCs) and the levonorgestrel-releasing intrauterine system (LNG-IUS)] on mental health. The aim of this work was to further study the association(s) between the use of OCs and the LNG-IUS and psychopathology.Study design: Data concerning adult women who participated in the national FINRISK Study Surveys in Finland in 1997, 2002 and 2007 were analyzed. The associations between the current use, as well as the duration of use of OCs and the LNG-IUS vs. mood symptoms, psychological and physical symptoms and recent psychiatric diagnoses were tested.Results: A negative association between the current use of OCs and Beck Depression Inventory-13 (BDI-13) score was found. Some other negative associations, all characterized by a small effect size, were detected between current use of OCs and the BDI items feelings of dissatisfaction, feelings of uselessness, irritability, lost interest in people and lost appetite. Additionally, only weak positive associations were found between the duration of OC use and irregular heart rate, insomnia and recent anhedonia. No noteworthy associations emerged between current use of the LNG-IUS, or its duration, and any of the inquired items.Conclusion: The use of hormonal contraception is not associated with negative influence on mental health. Current OC use seems to be associated with better mood, whereas the associations between duration of use of hormonal contraception and mental health effects are not clear.

Clinical diagnosis of completeness of medical abortion by nurses: a reliability study in Mozambique - Corrected Proof

2012-03-30

Abstract: Background: The provision of medical abortion continues to rely on routine use of ultrasound to confirm expulsion of pregnancy. However, the absence of ultrasound in most of the health facilities in developing countries and the additional training required to enable providers to use ultrasound is often prohibitive. The purpose of this study was to compare clinical history and physical examination with ultrasound in confirming completion of abortion.Study Design: A total of 718 women consented for medical abortion with misoprostol and were assessed for pregnancy expulsion by nurses and gynecologists. Nurses used history and physical examination while gynecologists used ultrasound to establish their diagnoses.Results: Nurses' clinical diagnoses for complete abortion, incomplete abortion and ongoing pregnancy were 83% (SE 0.01), 15% (SE 0.01) and 2% (SE 0.01), respectively. When gynecologists used ultrasound, the diagnoses for complete abortion, incomplete abortion, an ongoing pregnancy were 80% (SE 0.01), 17% (SE 0.01) and 3% (SE 0.01), respectively. Overall, nurses agreed with gynecologist diagnoses in 84% of cases, with a κ coefficient of 0.49 (SE 0.06) and chance-corrected first-order agreement (AC1) of 0.81 (SE 0.02). Agreement was very high for the diagnosis of complete abortion (AC1 0.89; SE 0.02), while it was moderate for ongoing pregnancy (AC1 0.58; SE 0.22) and incomplete abortion (AC1 0.45; SE 0.08).Conclusions: Clinical history and physical examination alone, without the use of ultrasonography, are effective for the determination of successful pregnancy expulsion. However, greater emphasis is required on the clinical identification of ongoing pregnancy during any training of providers.

Does using tampons or menstrual cups increase early IUD expulsion rates? - Corrected Proof

Ellen R. Wiebe, Konia J. Trouton — 2012-03-30

Abstract: Background: Many intrauterine device (IUD) users utilize intravaginal menstrual cups or tampons during menses, but no studies have investigated the impact this practice may have on IUD expulsions.Study Design: Retrospective chart survey.Results: Of the 930 women having IUDs placed and reporting menstrual protection, 10.3% (96) used menstrual cups, 74.2% (690) used tampons, and 43.2% (402) used pads (many women reported using more than one method). In the 743 women with adequate follow-up information, there was a full or partial expulsion (i.e., part of the IUD in the cervical canal) rate of 2.5% (27) during the first 6 weeks after insertion. There was no difference in the women using cups, tampons or pads (confidence intervals overlap).Conclusions: From this study, there is no evidence that women who report using menstrual cups or tampons for menstrual protection had higher rates of early IUD expulsion.

The effects of 2 mg chlormadinone acetate/30 mcg ethinylestradiol, alone or combined with spironolactone, on cardiovascular risk markers in women with polycystic ovary syndrome - Corrected Proof

2012-03-30

Abstract: Background: Polycystic ovary syndrome (PCOS) is an endocrine disorder associated with metabolic dysfunction and changes in cardiovascular risk markers, and using oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS. Thus, the primary objective of this study was to assess the effects on arterial function and structure of an OC containing chlormadinone acetate (2 mg) and ethinylestradiol (30 mcg), alone or combined with spironolactone (OC+SPL), in patients with PCOS.Study Design: This was a randomized, controlled clinical trial. Fifty women with PCOS between 18 and 35 years of age were randomized by a computer program to use OC or OC+SPL. Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers for cardiovascular disease were also analyzed. The intragroup data were analyzed using analysis of variance with Tukey's post hoc test. A multivariate linear regression model was used to analyze the intergroup data.Results: At 12 months, the increase in mean total cholesterol levels was greater in the OC+SPL group than in the OC group (27% vs. 13%, respectively; p=.02). The increase in mean sex hormone-binding globulin levels was greater in the OC group than in the OC+SPL group (424% vs. 364%, respectively; p=.01). No statistically significant differences between the groups were found for any of the other variables.Conclusion: The addition of spironolactone to an OC containing chlormadinone acetate and ethinylestradiol conferred no cardiovascular risk-marker advantages in young women with PCOS.

The New York City mayoral abortion training initiative at public hospitals - Corrected Proof

Maryam Guiahi, Corey Westover, Sahnah Lim, Carolyn L. Westhoff — 2012-03-30

Abstract: Background: We set out to describe and understand the first-ever abortion training political initiative on the provision of abortion services and abortion residency training.Study Design: We completed in-depth interviews with 22 participants (response rate of 92%) who have knowledge of abortion training and services in the New York City (NYC) public hospital system before and/or after the initiative. We used grounded theory to describe the initiative's effects.Results: Respondents identified strategies that helped achieve renovation of abortion facilities, updating of abortion services and protocols, and training of abortion providers. Respondents also identified public health impacts including improvement of abortion services, empowerment of abortion providers, and legitimization of abortion training and services.Conclusion: This NYC political initiative can be a model for other city governments to influence obstetrics and gynecology resident training and the provision of abortion services.

Antiabortion violence in the United States - Corrected Proof

Jennefer A. Russo, Kristin L. Schumacher, Mitchell D. Creinin — 2012-03-30

Abstract: Background: This study was conducted to determine if an association exists between the amount of harassment and violence directed against abortion providers and the restrictiveness of state laws relating to family planning.Study Design: We used responses from a July 2010 survey of 357 abortion providers in 50 states to determine their experience of antiabortion harassment and violence. Their responses were grouped and analyzed in relation to a published grading of state laws in the United States (A, B, C, D and F) as they relate to restrictions on family planning services.Results: Group by group comparison of respondents illustrates that the difference in the number of reported incidents of minor vandalism by group is statistically significant (A vs. C, p=.07; A vs. D, p=.017; A vs. F, p=.0002). Incidents of harassment follow a similar pattern. There were no differences noted overall for violence or major vandalism. Major violence, including eight murders, is a new occurrence in the last two decades.Conclusions: Harassment of abortion providers in the United States has an association with the restrictiveness of state abortion laws. In the last two decades, murder of abortion providers has become an unfortunate part of the violence.

Effect of hormonal contraceptives on vitamin B12 level and the association of the latter with bone mineral density - Corrected Proof

Abbey B. Berenson, Mahbubur Rahman — 2012-03-30

Abstract: Background: The study was conducted to estimate the effect of depot medroxyprogesterone acetate (DMPA) and oral contraceptives (OC) containing 20 mcg ethinyl estradiol on serum B12 and whether observed changes impact bone mineral density (BMD).Study Design: Serum B12 and BMD at the lumbar spine and femoral neck were measured on 703 women using OC, DMPA or nonhormonal (NH) birth control at baseline and every 6 months thereafter for 3 years.Results: OC and DMPA users experienced greater decreases in B12 than NH users (p<.001). A sharp decrease in B12 was observed during the first 6 months of hormonal contraceptive use (OC: 97 pg/mL and DMPA: 64 pg/mL) in contrast to 14 pg/mL among NH users (20%, 13% and 3% of their baseline values, respectively). Over the following 30 months, B12 levels of OC users remained almost flat, while DMPA users had a further 22-unit decrease. Very few women demonstrated B12 deficiency. Moreover, B12 levels were not associated with BMD.Conclusion: Hormonal contraception causes B12 levels to decrease, but this does not appear to be clinically significant or affect BMD.

A qualitative study of contraceptive understanding among young adults - Corrected Proof

2012-03-30

Abstract: Background: This study describes contraceptive understanding, sources of information and consequences of contraceptive misunderstandings among urban, young adults.Study Design: We used qualitative data from 16 focus groups and 53 interviews with Puerto Rican and African American men and women aged 18–25 years from Philadelphia and Hartford. We categorized and compared assertions made about all contraceptive methods' side effects, effectiveness and use using an iterative process.Results: Participants considered contraceptive use worthwhile but felt that it carried risks of problematic side effects and contraceptive failure, with variation among methods. Men knew most about condoms and withdrawal and trusted both more than women. Personal or second-hand experience was the dominant source of information on contraceptive understanding. Misunderstandings about contraception affected their relationships and risk of unintended pregnancy.Conclusion: Contraceptive understanding is a powerful determinant of contraceptive use and limits the options perceived by young adults to prevent pregnancy. Research is needed to strengthen contraceptive counseling and outreach in ways that better leverage peer influence.

The effect on use of making emergency contraception available free of charge - Corrected Proof

Sharon T. Cameron, Rosemary Gordon, Anna Glasier — 2012-03-30

Abstract: Background: Cost is a barrier to use of emergency contraception (EC). Since 2008, EC has been available free of charge without restriction in pharmacies throughout Scotland. A survey of EC use among women requesting abortion in 2010 allows comparison of use reported in earlier surveys, when EC was only available on prescription and when EC was available from the pharmacy but at a cost.Study Design: A questionnaire survey about knowledge of the availability of free EC from pharmacies, and its use to prevent the index pregnancy, was performed among 204 women requesting abortion in Edinburgh, Scotland.Results: Seventy percent of 204 respondents (n=143) knew that EC was available free from pharmacies; 22 (11%) had used it in the cycle in which conception occurred. EC use was not influenced by knowledge of its availability free of charge. Women from affluent areas were significantly more likely to have used EC to try to prevent the pregnancy than counterparts from less affluent areas (p=.041).Conclusions: Neither availability from the pharmacy nor removal of a charge for EC has increased its use among women having an abortion in Scotland.

Contraceptive choices of overweight and obese women in a publically funded hospital: possible clinical implications - Corrected Proof

Renata Scott-Ram, Julie Chor, Varija Bhogireddy, Louis Keith, Ashlesha Patel — 2012-03-29

Abstract: Background: Despite the growing obesity epidemic in the United States, family planning for overweight and obese women has been understudied. The aim of this study was to describe the contraception methods selected by normal weight, overweight and obese women.Study Design: We retrospectively reviewed 7262 charts of women who underwent first trimester surgical termination of pregnancy at the John H. Stroger, Jr. Hospital of Cook County between January 1, 2008, and January 1, 2010. We analyzed the relationship between body mass index (BMI) and choice of contraceptive method, after adjusting for age, race, smoking and level of education.Results: When compared to patients with BMI <25 kg/m2, overweight (BMI 25–29.9 kg/m2) and obese patients (BMI ≥30 kg/m2) were more likely to select the intrauterine device (OR 1.3, 95% CI 1.28–1.32 for overweight; OR 1.6, 95% CI 1.59–1.61 for obese), contraceptive ring (OR 1.4, 95% CI 1.28–1.52 for overweight; OR 1.6, 95% CI 1.57–1.63 for obese) and tubal ligation (OR 1.5 95% CI 1.44–1.62 for overweight; OR 2.9, 95% CI 2.79–3.01 for obese). They were less likely to choose injectable contraception (OR 0.7, 95% CI 0.59–0.81 for overweight; OR 0.52, 95% CI 0.48–0.56 for obese). There was no relationship between BMI and choice of condoms, oral contraceptive pills and implantable methods.Conclusion: In our population, the contraceptive choices of overweight and obese women differed from those of normal weight women. These differences in contraceptive selection are important to recognize in light of the potential effect of BMI on the safety and efficacy of different contraceptive methods. Further research is needed to evaluate the contraceptive preferences, risks and benefits for overweight and obese women.

Resources and procedures in the treatment of heavy menstrual bleeding with the levonorgestrel-releasing intrauterine system (LNG-IUS) or hysterectomy in Brazil - Corrected Proof

2012-03-29

Abstract: Background: Heavy menstrual bleeding (HMB) is the most common complaint of women seeking gynecological care. Treatments included surgical or medical options including hysterectomy and the levonorgestrel-releasing intrauterine system (LNG-IUS) due to the profound suppression of endometrial growth that intrauterine LNG exerts which results in amenorrhea or in a reduction of blood loss.Objective: The study was conducted to evaluate the resources and procedures involved in inserting an LNG-IUS compared to performing hysterectomy in women with HMB in a public sector hospital in Brazil.Study design: Two cohorts of women were studied: women who accepted an LNG-IUS (n=124) and matched women who underwent hysterectomy on the same day (n=122). We evaluate the number of procedures carried out in each group of women, including those performed before the decision was made to insert an LNG-IUS or to perform hysterectomy, the insertion of the device itself and the surgical procedure, in addition to the procedures and complications registered up to 1 year after LNG-IUS insertion or hysterectomy.Results: Age and the duration of HMB were significantly lower in the LNG-IUS acceptors than women at the hysterectomy group. The numbers of gynecological consultations and Pap smears were similar in both groups; however, women in the hysterectomy group also underwent laboratory tests, ultrasonography, chest X-ray and electrocardiogram. In the hysterectomy group, the main complications were hemorrhage (six), bladder/bowel perforation (four), complications with anesthesia (one), ureteral reimplantation required (one) and abdominal pain (two). At 1 year, HMB was controlled in 83.1% of women in the LNG-IUS group, and 106 women continued with the device.Conclusions: Both treatments were effective in HMB control. Fewer resources and complications were observed in LNG-IUS acceptors when compared to hysterectomy. The LNG-IUS represents a good strategy for reducing the number of hysterectomies and the resources required for women with HMB.

Addressing reproductive autonomy to prevent repeat unintended pregnancy - Corrected Proof

Ushma D. Upadhyay — 2012-03-29

We appreciate the comments from Drs. Lapane and Magnusson on our article, “Contraceptive discontinuation and repeat unintended pregnancy within 1 year after an abortion” . We are in agreement that repeat unintended pregnancies are a symptom of the larger problem of disempowerment where women lack control over their sexual and reproductive lives. We believe that there is a need for interventions to address the larger contextual issues in women's lives and to intervene at earlier stages. To this end, we have initiated work on the development of a reproductive autonomy scale that could potentially be used at the time of abortion counseling or in other clinical settings to identify women at highest risk of unintended pregnancy. The newer work by Magnusson and colleagues will provide important context to our new measure.

Management of missing strings in users of intrauterine contraceptives - Corrected Proof

2012-03-29

Abstract: Background: A common question among health care professionals is how to manage nonvisible strings in users of intrauterine contraceptives (IUCs) at repeat follow-up visits. This study assessed the position of the IUCs in women who consulted repeatedly with nonvisible IUC strings.Study Design: The medical records of the clinic were reviewed to identify new acceptors and switchers who had an IUC inserted between 1990 and 2009. All women were identified whose IUC string could not be visualized at the external os of the cervix by the health care professional at any given follow-up visit, even after attempting a standard maneuver of sweeping the strings from the cervical canal using a cervical brush or trying to visualize the strings in the cervical canal using colposcopy. Data were also retrieved on the use of ultrasonography and/or pelvic X-ray to assess IUC position, as well as data from any subsequent visits at which the IUC strings were nonvisible.Results: The medical charts of 14,935 patients using an IUC were reviewed, and 750 women (5.0%) presenting for the first time with missing IUC strings at any follow-up visit were identified. Ultrasound scans showed the IUC to be in situ in 735 cases (98.0%), while 9 women (1.2%) had expelled the device and, in 5 cases (0.7%), the device was found in the pelvis following uterine perforation. IUC strings were missing on a second occasion in 297 cases. The device was found to be in situ in 295 cases (99.3%) and had been expelled in 2 (0.7%). At subsequent consultations, (between 1 and 18 years after the first consultation), strings were missing in 113, 55, 19 and 5 cases. In 111 (98.2%), 54 (98.2%), 18 (94.7%) and 5 (100%) of these cases, respectively, the IUC was found to be in situ, while in the remaining cases, the device had been expelled.Conclusions: Missing IUC strings are an uncommon finding, and ultrasonography confirmed that the device was in situ in the majority of these cases. For women with persistent missing IUC strings after one ultrasound scan that has verified appropriate intrauterine position, given the 2.4% likelihood that expulsion may have occurred at the time of subsequent visits, repeating the ultrasound (if available) should be considered for at least one (and possibly two) additional women's visit.

Reproductive health experiences of women with cardiovascular disease - Corrected Proof

2012-03-29

Abstract: Background: Limited research exists exploring contraceptive and pregnancy experiences of women with cardiovascular diseases.Study Design: We conducted semistructured interviews with reproductive-age women with chronic hypertension or peripartum cardiomyopathy exploring thoughts and behaviors regarding future fertility. Transcribed interviews were coded and analyzed identifying salient themes.Results: We interviewed 20 women with chronic hypertension and 10 women with peripartum cardiomyopathy. Women described a spectrum of perspectives regarding the relationship between disease and fertility: from complete disconnect to full integration of diagnosis and future fertility plans. Integration of reproductive and cardiovascular health was influenced by and reflected in circumstances of diagnosis, pregnancy-related experiences, contraception-related experiences and conceptualization of disease risk related to reproductive health.Conclusions: Providers must better understand how women perceive and consider their reproductive and cardiovascular health in order to optimize contraceptive care of women with cardiovascular disease and help them make safe, informed decisions about future fertility.

Discriminant analysis of the metabolic effects of a new combined contraceptive vaginal ring containing Nestorone/EE vs. a second-generation oral contraceptive containing levonorgestrel/EE - Corrected Proof

Mandana Rad, Jacobus Burggraaf, Marieke L. de Kam, Adam F. Cohen, Cornelis Kluft — 2012-03-26

Abstract: Background: Discriminant analysis (DA) was performed on data of two combined hormonal contraceptives (CHC) differing in estrogen ratio to explore whether a combination of variables rather than a single variable distinguishes CHCs better.Study Design: Data were used of a parallel study in premenopausal women treated for three cycles (21 days on, 7 days off) with a contraceptive vaginal ring delivering Nestorone and ethinyl estradiol (EE) or an oral contraceptive containing levonorgestrel and EE. DA was performed on the change from baseline (CFB) and the end-of-treatment values at 3 months for lipids, sex-hormone binding globulin (SHBG), C-reactive protein, angiotensinogen, blood pressure and hemostasis variables, and on the hemostasis variables only.Results: For the complete set, the CFB for factor VII (FVII), SHBG and plasminogen (PLG), or end-of-treatment SHBG- and FVII level discriminated the treatments best. Maximal discrimination for the hemostasis data was by CFB for FVII and PLG or end-of-treatment FVII level.Conclusions: DA identifies differences between CHCs and may provide information on the factors associated with thrombotic risk.

Evaluation of the effects of rifampicin, ketoconazole and erythromycin on the steady-state pharmacokinetics of the components of a novel oral contraceptive containing estradiol valerate and dienogest in healthy postmenopausal women - Corrected Proof

2012-03-26

Abstract: Background: We evaluated the effects of cytochrome P450 3A4 (CYP3A4) induction and inhibition on steady-state pharmacokinetics of the components of a novel oral contraceptive (OC) containing estradiol valerate (E2V) and dienogest (DNG).Study Design: CYP3A4 induction was assessed in an open-label, one-arm study. Sixteen healthy postmenopausal women received E2V 2 mg/DNG 3 mg (days 1–17) and concomitant rifampicin (600 mg, days 12–16). Ratios of the area under the serum concentration–time curve between 0 and 24 h [AUC(0–24 h)] and maximum serum concentration (Cmax) of E2 and DNG on days 17 and 11 (after and before rifampicin intervention) are presented. CYP3A4 inhibition was investigated in an open-label, parallel-group study in 24 healthy postmenopausal women receiving E2V 2 mg/DNG 3 mg (days 1–14) and concomitant ketoconazole (400 mg, n=12) or erythromycin (500 mg three times daily, n=12) on days 8–14. Mean ratios of AUC(0–24 h) and Cmax of E2 and DNG on days 7 and 14 are presented.Results: Concomitant administration of rifampicin decreased systemic drug exposure and yielded geometric mean ratios for E2 Cmax and AUC(0–24 h) of 75% and 56%, respectively. Corresponding mean ratios for DNG were 48% and 17%, respectively. Ketoconazole coadministration increased systemic drug exposure and yielded ratios of E2 of 165% and 157%, respectively, and ratios of DNG of 194% and 286%, respectively. Erythromycin coadministration also resulted in increased mean Cmax and AUC(0–24 h) of both E2 and DNG. Geometric mean ratios of Cmax and AUC(0–24 h) for E2 were 151% and 133%, respectively. Corresponding ratios for DNG were 133% and 162%, respectively.Conclusions: Significant drug–drug interactions are apparent when CYP3A4 modulators are coadministered with the components of a novel OC containing E2V/DNG. Coadministration of CYP3A4 modulators should be avoided where possible, and another type of contraception should be used when coadministration of CYP3A4 inducers like rifampicin is unavoidable.

Condom type may influence sexual behavior and ejaculation and complicate the assessment of condom functionality - Corrected Proof

Lisa Haddad, Maria F. Gallo, Denise J. Jamieson, Maurizio Macaluso — 2012-03-26

Abstract: Background: Studies that evaluate condom effectiveness are affected by factors related to how the condom was used, and these factors may not be consistent between different types of condoms. Also, subjective assessments of the sexual act may be unreliable.Study Design: We performed a secondary data analysis of a randomized crossover trial of male and female condoms among 108 couples.Results: Self-reported duration and activeness of coital acts were significantly different for uses of the male condom compared to uses of the female condom. Fewer individuals reported ejaculation occurring with the female condom. Reliability of self-reports of ejaculation compared to a biological marker of semen detected inside the used male and female condoms was not strong.Conclusions: We found that sexual behaviors appear to differ by the type of condom used for the coital act. Studies should consider sexual behavior when evaluating condom effectiveness. Furthermore, studies would be strengthened by the use of a biological marker of semen to determine whether ejaculation, and therefore a true risk of exposure, occurred.

Body weight and composition in users of levonorgestrel-releasing intrauterine system - Corrected Proof

2012-03-26

Abstract: Background: There is little information about body weight and body composition (BC) among users of the levonorgestrel-releasing intrauterine system (LNG-IUS). The aim of this study was to evaluate body weight and BC in LNG-IUS users compared to users of the TCu380A intrauterine device (IUD).Study Design: A prospective study was done with 76 new users of both contraceptive methods. Women were paired by age (±2 years) and body mass index (BMI, kg/m2, ±2). Body weight and BC (% lean mass and % fat mass) were evaluated by a trained professional at baseline and at 1 year of contraceptive use. The BC measurements were obtained using Lunar DXA equipment. Weight and BC were evaluated in each woman at baseline and at 12 months and analyzed as the mean change within each woman. Then, the changes in weight and BC for each woman were calculated and then compared between LNG-IUS and TCu380A IUD users (paired data for each woman). The central-to-peripheral fat ratio was calculated by dividing trunk fat by the upper and lower limb fat.Results: There were no significant differences at time of IUD insertion between LNG-IUS and TCu380A IUD users regarding age (mean±SD) (34.4±7.5 vs. 33.9±8.0 years), BMI (25.3±4.1 vs. 25.9±4.1) and number of pregnancies (1.9±0.2 vs. 1.7±0.2), respectively. Mean body weight gain of 2.9 kg was observed among LNG-IUS users at 12 months (p=.0012), whereas the body weight of TCu380A IUD users only increased by 1.4 kg (p=.067). There was no significant difference in body weight change between the two groups of users at 12 months. The variation in the central-to-peripheral fat ratio was the same between the two groups (−1.6% vs. −0.2%; p=.364). LNG-IUS users showed a 2.5% gain in fat mass (p=.0009) and a 1.4% loss of lean mass, whereas TCu380A IUD users showed a loss of 1.3% of fat mass (p=.159) and gain of 1.0% of lean mass (p=.120). TCu380A IUD users gained more lean mass than LNG-IUS users (p=.0270), although there was no significant difference between the two groups after 12 months of use.Conclusions: Although an increase in mean fat mass among LNG-IUS users at 12 months of use was observed, it should be noted that an increase of body weight was also observed in both groups after 1 year of insertion of the device. However, a study with a larger number of women and long-term evaluation is necessary to evaluate these body changes.

The antifertility effectiveness of a novel copper-containing composite used in intrauterine contraceptive devices and the releasing behavior of cupric ions contained in the composite in rats - Corrected Proof

Xiangchi Peng, Shanshan Hu, Tianqing Meng, Jinping Suo, Chengliang Xiong — 2012-03-26

Abstract: Background: This study was conducted to investigate the antifertility effectiveness of a novel copper-containing composite used in intrauterine contraceptive devices (IUDs) that contain cupric chloride/silicon dioxide/poly(vinyl alcohol) (CuCl2/SiO2/PVA) and the releasing behavior of cupric ions in the composite into the serum and uterine fluid in rats.Study Design: Two hundred and forty sexually mature female Sprague–Dawley rats were randomly divided into six groups: sham-operated control group (n=20), bulk copper group (Cu group, n=40), SiO2/PVA group (n=40), CuCl2/SiO2/PVA groups I (n=40, copper ion was released from IUD at a rate of 5–10 mcg/220 mm2 per day) and II (n=40, copper ion was released from IUD at a rate of 10–20 mcg/220 mm2 per day), and normal control group (n=20). IUD was inserted into the uterus of rats after acclimatization of 1 week .At different time points after implantation of the IUDs, cupric ion concentrations were measured in the serum and local uterine fluid in each group by flame atomic absorption, respectively. After 30 days of insertion, half of the rats in each group were mated with fertile male rats, and the antifertility rates were observed at 14 days of pregnancy. After the IUDs were removed, the remaining rats in each group were mated again to determine their fertility.Results: Antifertility rates in the Cu group and CuCl2/SiO2/PVA groups I and II were 100%, and each of these rates was significantly higher than that in the other groups (p .05). No significant change in time dependence was found for the serum cupric ion concentrations in each group (p>.05), while the local uterine fluid cupric ion concentrations in the other groups were significantly lower than those in the Cu group (p<.05) and without a burst release of cupric ions in the initial days of application.Conclusions: The novel copper-containing composite used in intrauterine contraceptive devices (CuCl2/SiO2/PVA composite IUD) had a low pregnancy rate and high contraceptive efficacy without a burst release of cupric ions in the initial days of application.

Comment on research article: “Co-prescription of Antiepileptic Drugs and Contraceptives” - Corrected Proof

Alyson Elliman, Louise Melvin — 2012-03-26

The issue raised by Wang et al. is of vital importance in avoiding unintended pregnancies and highlights the need for initial and continuing updating for prescribers of antiepileptic drugs and contraception.

Reply to the Letter to the Editor on “Co-prescription of Antiepileptic Drugs and Contraceptives” - Corrected Proof

Hao Wang, Jens H. Bos, Lolkje T. de Jong-van den Berg — 2012-03-26

We appreciate the valuable comments by Elliman and Melvin, especially their reference to the Faculty of Sexual and Reproductive Healthcare Clinical Guidance of 2011 and update of 2012 , which were not yet available to us at the time of the submission of our manuscript.

Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg - Corrected Proof

2012-03-26

Abstract: Background: This prospective noninterventional study assessed the contraceptive efficacy, safety and the effects on signs of androgenization of the generic oral contraceptive containing 2 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) in a real-world setting.Study Design: A total of 1440 women were investigated during a six-cycle period by 229 gynecological practices throughout Germany.Results: The adjusted Pearl index was 0.136 (unadjusted: 0.271). Of 463 patients with cycle irregularities at baseline, 83.4% had regular cycles after six cycles. Likewise, 74.1% of 162 patients with spotting or breakthrough bleeding at baseline were free from these symptoms at the end of study. The percentage of patients with dysmenorrhea decreased significantly from baseline (36.5%) to visit 3 after six cycles (12.3%; p=.0001), with a significant reduction in the use of pain medication (p<.0001). Additionally, the number of patients with skin and hair problems was significantly reduced (skin: 56.3% at baseline, 19.6% after six cycles; hair: 45.7% at baseline, 13.4% after six cycles; p=.001). CMA/EE was well tolerated by the patients, and 89.44% of the gynecologists were satisfied with the treatment.Conclusion: Generic CMA/EE exhibits very good contraceptive efficacy, cycle control and dysmenorrhea reduction. Furthermore, treatment with generic CMA/EE led to a favorable reduction of skin and hair problems in our study.

Tailored health messaging improves contraceptive continuation and adherence: results from a randomized controlled trial - Corrected Proof

2012-03-26

Abstract: Background: Discontinuation and incorrect use of contraceptive methods may contribute to as many as 1 million unintended pregnancies annually in the United States. Interventions to improve contraceptive method continuation and adherence are needed.Study Design: A three-arm randomized controlled trial was conducted at two family planning sites testing the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients who continued use of their chosen contraceptive method 4 months after the family planning visit (n=224).Results: In analyses adjusting for clinical site of recruitment, family planning patients who used the module and received individually tailored health materials (n=78), compared to those in the control group (n=70), were significantly more likely to continue use of their chosen contraceptive method [95% compared to 77%; odds ratio (OR)=5.48; 95% confidence interval (CI): 1.72–17.42] and to adhere to their method (86% compared to 69%; OR=2.74; 95% CI: 1.21–6.21). No significant differences in these outcomes were found for participants who used the module but did not receive tailored materials (n=76), compared to the control group.Conclusions: Tailored health materials significantly improved contraceptive method continuation and adherence. Additional research on the impact of the intervention on continuation and adherence in a larger sample and over a longer follow-up period is merited.

Complications of surgical termination of second-trimester pregnancy in obese versus nonobese women - Corrected Proof

2012-03-26

Abstract: Background: Obesity is becoming increasingly common in obstetric and gynecologic populations, which may affect the safety of surgical termination of pregnancy.Study Design: We performed a retrospective review of all patients undergoing second-trimester surgical termination of pregnancy by under ultrasound guidance termination between 13 0/7 and 24 0/7 weeks of gestational age (GA) to compare perioperative risks in obese and nonobese women. Complication rates, operative times and anesthesia times were compared between obese [body mass index (BMI) ≥30 kg/m2] and nonobese women (BMI <30).Results: Of 1044 women, 29.0% were obese. The mean complication rate was 6.1% and similar between groups (5.5% nonobese, 7.6% obese, p=.20). Operative times were 4.4 min longer and mean anesthesia times were 5 min longer in obese patients (p<.001 for each). There was a nonsignificant trend toward more complications with gestational ages above 18 weeks (5.5% vs. 7.7%, p=.20). A history of one or more cesarean sections had an independent association with major complications after adjustment for confounders (adjusted odds ratio 4.2, p=.001).Conclusions: Both anesthesia and operative times were modestly increased in obese women versus nonobese women undergoing second-trimester surgical termination, without significant differences in complication rates. For patients at advanced GA with prior cesarean delivery, clinicians should be aware of the potential increase in complications as well as increased operative time in obese women, and counsel appropriately.

Suppression of ovarian activity with a low-dose 21/7-day regimen oral contraceptive containing ethinylestradiol 20 mcg/drospirenone 3 mg in Japanese and Caucasian women - Corrected Proof

Yuzuru Anzai, Doris Heger-Mahn, Ilka Schellschmidt, Joachim Marr — 2012-03-09

Abstract: Background: Two studies assessed the effect of a low-estrogen-dose 21/7-day oral contraceptive containing ethinylestradiol and drospirenone (EE 20 mcg/drsp 3 mg) on ovarian activity in Japanese and Caucasian women.Study Design: Study 1 was conducted in Japanese women (20–35 years), and Study 2 was conducted in Caucasian women (18–35 years). All women received EE 20 mcg/drsp 3 mg in a 21-day active pill regimen. The primary endpoint was the proportion of women with ovulation inhibition (Hoogland score <6; as assessed by transvaginal ultrasonography) during treatment cycle 2.Results: Japanese (n=23) and Caucasian (n=30) women received two cycles of study treatment. During treatment cycle 2, ovulation was inhibited in 100% and 92.9% of Japanese and Caucasian women, respectively.Conclusions: EE 20 mcg/drsp 3 mg in a 21/7-day regimen provides comparable ovarian suppression in Japanese and Caucasian women, with normal ovarian function resuming shortly after treatment end in both populations.

Randomized controlled trial of a computer-based module to improve contraceptive method choice - Corrected Proof

2012-03-09

Abstract: Background: Unintended pregnancy is common in the United States, and interventions are needed to improve contraceptive use among women at higher risk of unintended pregnancy, including Latinas and women with low educational attainment.Study Design: A three-arm randomized controlled trial was conducted at two family planning sites serving low-income, predominantly Latina populations. The trial tested the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients choosing an effective method of contraception (<10 pregnancies/100 women per year, typical use). Participants were randomized to complete the module and receive tailored health materials, to complete the module and receive generic health materials, or to a control condition.Results: In intent-to-treat analyses adjusted for recruitment site (n=2231), family planning patients who used the module were significantly more likely to choose an effective contraceptive method: 75% among those who received tailored materials [odds ratio (OR)=1.56; 95% confidence interval (CI): 1.23–1.98] and 78% among those who received generic materials (OR=1.74; 95% CI: 1.35–2.25), compared to 65% among control arm participants.Conclusions: The findings support prior research suggesting that patient-centered interventions can positively influence contraceptive method choice.

Quantitative levonorgestrel plasma level measurements in patients with regular and prolonged use of the levonorgestrel-releasing intrauterine system - Corrected Proof

2012-03-09

Abstract: Background: The levonorgestrel-releasing intrauterine system (LNG-IUS) is well accepted as an easy-to-use contraceptive with an excellent side-effect profile. It contains a reservoir of 52 mg of levonorgestrel (LNG) with continuous release of the steroid. Its contraceptive use is approved for 5 years. The aim of this study was to determine the plasma concentration of LNG and its variation with time in patients with in-dwelling LNG-IUS Mirena®.Study Design: In this study, we determined LNG plasma concentrations in 110 women with LNG-IUS at different time points of use. Time from insertion of the system in the study population ranged from 20 days to 11.1 years. Quantitative LNG levels were determined using a validated liquid chromatography–tandem mass spectrometry assay.Results: The mean±SD LNG plasma level in all women was 147±59 pg/mL. A highly significant negative correlation between LNG plasma level and LNG-IUS time of use could be demonstrated. In the first year of use, LNG plasma level was as high as 191±71 pg/mL, decreasing to 157±68 pg/mL in the second year and 134±41 pg/mL in the third year. Even after exceeding the recommended period of LNG-IUS use, systemic LNG concentrations were detectable: 133±38 pg/mL in the sixth year, 133±48 pg/mL in the seventh year and 117±45 pg/mL in the eighth year. Furthermore, a significant negative correlation between LNG plasma level and body mass index could be shown.Conclusion: Systemic LNG concentrations can be found in all patients with LNG-IUS IUS. However, concentrations are much lower than in other forms of LNG application. Moreover, this study demonstrates that a systemic effect of LNG-IUS can also be found after the recommended contraceptive lifespan of 5 years.

Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance - Corrected Proof

2012-03-05

Abstract: Background: Prostate-specific antigen (PSA), a biomarker for semen exposure, may provide a more objective measure of condom failure than subject self-reports. Methods for measuring PSA vary and their comparability with respect to assessing condom performance has not been adequately evaluated. This study compared results from three different PSA assays of vaginal samples collected by subjects in a randomized clinical trial which compared the performance of female condoms.Study Design: We selected 30 pairs of pre- and post-coital vaginal samples from subjects who reported condom functionality problems or whose original PSA assay was positive. Samples were retested using three different PSA assays [quantitative enzyme-linked immunoassay (EIA), rocket immune-electrophoresis (RIE) and chromatographic immunoassay (CIA)]. We compared the proportion of condom uses where the post-coital PSA result indicated semen exposure for each of the three assays.Results: Despite varying levels of sensitivity, the results from all three assays were remarkably consistent. Self-reported condom failures did not correlate well with positive PSA results, suggesting that exclusive reliance on either PSA or user self-report may be inadequate for assessing condom functionality.Conclusion: In combination with user self-report of condom failure, PSA testing provides a reliable, objective marker of condom functionality. Studies based on PSA testing may improve on conventional contraceptive clinical trials by offering a more direct assessment of a condom product's ability to prevent semen exposure.

Conducting high-quality research on the psychological impact of oral contraceptive use - Corrected Proof

Kelly D. Cobey, Abraham P. Buunk — 2012-03-05

Oral contraceptives are the most extensively studied pills in the history of medicine . It is therefore unfortunate to see how little of this research has been directed towards the study of potential psychological consequences resulting from use. Scientists, health care providers and advocates who read this journal are privy to the latest breaking research on improved contraceptive technology from researchers in the fields of chemistry, biochemistry, physiology, endocrinology, demography and biology; however, rarely are readers presented with research testing the potential influence of oral contraceptives on psychological well-being. While we obviously concede that it is of extreme importance to identify physical health risks associated with oral contraceptive pill use, it is unfortunate that such research is often carried out entirely independently of research examining the potential for psychological consequences. To date, systematically controlled studies investigating the psychological effects of oral contraceptives tend to be limited to research on generalized mood, depression and libido. While great work has been done in these areas (e.g., Refs. ), research has not yet adequately addressed the psychological impact of contraceptive use within a wider context, namely, interpersonal relationships. Accordingly, a number of interesting questions remain unanswered, for example: Are changes in female mood reported in contraceptive users noticeable to male partners, friends or colleagues? Do changes in libido affect the durability of romantic relationships?