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Prophylactic vaginal dinoprostone administration six hours prior to copper-T380A intrauterine device insertion in nulliparous women: A randomized controlled trial

      Abstract

      Objective

      To determine the effectiveness of 3 mg vaginal dinoprostone administered six hours prior to copper intrauterine device (IUD) insertion compared to placebo in increasing ease of insertion and reducing insertion pain among nulliparous women. Study design. This was a single-center double-blinded randomized controlled trial (RCT). We randomly divided the two hundred nulliparous women requesting a copper T380A IUD to receive 3 mg vaginal dinoprostone or placebo six hours before IUD insertion. The primary outcome was provider ease of insertion. Patients reported their perceived insertion pain using a 10 cm visual analog scale (VAS). We also reported number of failed IUD insertions.

      Results

      Baseline characteristics were similar between groups. Ease of insertion score was lower in dinoprostone group than placebo group (3.6 ± 2.5 vs. 5.4 ± 2.8; p < 0.01) denoting easier insertion for clinicians in dinoprostone group. Mean pain score during copper IUD insertion was lower in dinoprostone group (3.7 ± 2.3 vs. 5.0 ± 2.8; p < 0.01). Failed IUD insertion occurred in two cases of dinoprostone group (2%) versus four cases in control group (4%) (p-value; 0.68).

      Conclusions

      Although vaginal dinoprostone administration six hours prior to copper IUD insertion in nulliparous women leads to an easy IUD insertion, we do not routinely advise it as the reduction in IUD insertion pain scores with vaginal dinoprostone lacked clinical significance.

      Implications

      In settings where it is feasible to provide dinoprostone vaginally six hours before copper IUD insertion, clinicians will find insertion easier, and nulliparous women may experience somewhat less pain during the procedure. Where waiting six hours is practical, this may prove to be useful.

      Keywords

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      References

        • Trussell J.
        Contraceptive failure in the United States.
        Contraception. 2011; 83: 397-404
      1. Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, et al. U.S. Medical eligibility criteria for contraceptive use, 2016. Morb Mortal Wkly Rep Recomm Rep 2016;65:1–103.

        • Yen S.
        • Saah T.
        • Hillard P.J.A.
        IUDs and adolescents–an under-utilized opportunity for pregnancy prevention.
        J Pediatr Adolesc Gynecol. 2010; 23: 123-128
        • Buhling K.J.
        • Hauck B.
        • Dermout S.
        • Ardaens K.
        • Marions L.
        Understanding the barriers and myths limiting the use of intrauterine contraception in nulliparous women: results of a survey of European/Canadian healthcare providers.
        Eur J Obstet Gynecol Reprod Biol. 2014; 183: 146-154
        • Lyus R.
        • Lohr P.
        • Prager S.
        Board of the society of family planning. use of the Mirena LNG-IUS and paragard CuT380A intrauterine devices in nulliparous women.
        Contraception. 2010; 81: 367-371
        • Teal S.B.
        • Romer S.E.
        • Goldthwaite L.M.
        • Peters M.G.
        • Kaplan D.W.
        • Sheeder J.
        Insertion characteristics of intrauterine devices in adolescents and young women: success, ancillary measures, and complications.
        Am J Obstet Gynecol. 2015; 213: e1-e5
        • McNicholas C.
        • Swor E.
        • Wan L.
        • Peipert J.F.
        Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration-approved duration.
        Am J Obstet Gynecol. 2017; 216: 586.e1-586.e6
      2. Committee on Adolescence. Contraception for adolescents. Pediatrics 2014;134:e1244-1256.

      3. Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception Work Group. Practice Bulletin No. 186: Long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol 2017;130:e251–69.

        • Wildemeersch D.
        • Hasskamp T.
        • Nolte K.
        • Jandi S.
        • Pett A.
        • Linden S.
        • et al.
        A multicenter study assessing uterine cavity width in over 400 nulliparous women seeking IUD insertion using 2D and 3D sonography.
        Eur J Obstet Gynecol Reprod Biol. 2016; 206: 232-238
        • Brown W.M.
        • Trouton K.
        Intrauterine device insertions: which variables matter?.
        J Fam Plann Reprod Health Care. 2014; 40: 117-121
        • Zapata L.B.
        • Jatlaoui T.C.
        • Marchbanks P.A.
        • Curtis K.M.
        Medications to ease intrauterine device insertion: a systematic review.
        Contraception. 2016; 94: 739-759
        • Liu A.
        • Lv J.
        • Hu Y.
        • Lang J.
        • Ma L.
        • Chen W.
        Efficacy and safety of intravaginal misoprostol versus intracervical dinoprostone for labor induction at term: a systematic review and meta-analysis.
        J Obstet Gynaecol Res. 2014; 40: 897-906
        • Abulnour A.A.E.-R.
        • Mohamed M.E.-M.
        • Khalaf W.M.
        Dinoprostone versus misoprostol for cervical ripening before diagnostic hysteroscopy in nulliparous women: a randomized controlled trial.
        Egypt J Hosp Med. 2018; 71: 2287-2293
        • Inal H.A.
        • Ozturk Inal Z.H.
        • Tonguc E.
        • Var T.
        Comparison of vaginal misoprostol and dinoprostone for cervical ripening before diagnostic hysteroscopy in nulliparous women.
        Fertil Steril. 2015; 103: 1326-1331
      4. Insertion technique for the Copper T380A IUD | RHL n.d. https://extranet.who.int/rhl/resources/videos/insertion-technique-copper-t380a-iud (accessed October 8, 2019).

        • Maged A.M.
        • Youssef G.
        • Eldaly A.
        • Omran E.
        • El Naggar M.
        • Abdel Hak A.
        • et al.
        Benefits of vaginal misoprostol prior to IUD insertion in women with previous caesarean delivery: a randomised controlled trial.
        Eur J Contracept Reprod Health Care Off J Eur Soc Contracept. 2018; 23: 32-37
      5. OpenEpi:Sample Size for X-Sectional,Cohort,and Clinical Trials n.d. http://www.openepi.com/SampleSize/SSCohort.htm (accessed October 9, 2019).

        • Todd K.H.
        • Funk K.G.
        • Funk J.P.
        • Bonacci R.
        Clinical significance of reported changes in pain severity.
        Ann Emerg Med. 1996; 27: 485-489
        • Gallagher E.J.
        • Liebman M.
        • Bijur P.E.
        Prospective validation of clinically important changes in pain severity measured on a visual analog scale.
        Ann Emerg Med. 2001; 38: 633-638
        • Grilo R.M.
        • Treves R.
        • Preux P.M.
        • Vergne-Salle P.
        • Bertin P.
        Clinically relevant VAS pain score change in patients with acute rheumatic conditions.
        Jt Bone Spine Rev Rhum. 2007; 74: 358-361
        • Samy A.
        • Abbas A.M.
        • Rashwan A.S.S.A.
        • Talaat B.
        • Eissa A.I.
        • Metwally A.A.
        • et al.
        Vaginal dinoprostone in reducing pain perception during diagnostic office hysteroscopy in postmenopausal women: a randomized, double-blind placebo-controlled trial.
        J Minim Invasive Gynecol. 2019;
        • Tan T.-C.
        • Yan S.Y.
        • Chua T.M.
        • Biswas A.
        • Chong Y.-S.
        A randomised controlled trial of low-dose misoprostol and dinoprostone vaginal pessaries for cervical priming.
        BJOG Int J Obstet Gynaecol. 2010; 117: 1270-1277
        • Ferraiolo A.
        • Dellacasa I.
        • Bentivoglio G.
        • Ferrero S.
        • Ragni N.
        Evaluation of patients’ satisfaction of cervical ripening using dinoprostone by either intravaginal gel or pessary: an open-label, randomized, prospective study.
        J Reprod Med. 2010; 423: 9-10
        • Fouda U.M.
        • Salah Eldin N.M.
        • Elsetohy K.A.
        • Tolba H.A.
        • Shaban M.M.
        • Sobh S.M.
        Diclofenac plus lidocaine gel for pain relief during intrauterine device insertion. A randomized, double-blinded, placebo-controlled study.
        Contraception. 2016; 93: 513-518
      6. Samy A, Abbas AM, Mahmoud M, Taher A, Awad MH, El husseiny T, et al. Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril 2019;111:553-561.e4.

        • Preutthipan S.
        • Herabutya Y.
        A randomized comparison of vaginal misoprostol and dinoprostone for cervical priming in nulliparous women before operative hysteroscopy.
        Fertil Steril. 2006; 86: 990-994
        • Kesrouani A.
        • Maalouf S.
        • Mansour F.
        • Attieh E.
        Use of oral misoprostol for cervical priming before hysteroscopy: a randomized comparison of two dosages.
        Gynecol Obstet Invest. 2016; 81: 333-338
        • Bastu E.
        • Celik C.
        • Nehir A.
        • Dogan M.
        • Yuksel B.
        • Ergun B.
        Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses.
        Int Surg. 2013; 98: 140-144
        • van der Griendt M.C.
        • Goldstuck N.D.
        Dilatation of the cervix with dinoprostone (‘Prepidil Gel’) prior to insertion of an intrauterine device: report of two cases.
        Adv Contracept. 1990; 6: 53-56