Abstract
The subject of this study to examine the safety and contraceptive efficacy of Norplant,
we undertook a 5-year study of follow-up of women initiating use of Norplant, intrauterine
device (IUD) or sterilization in eight developing countries. Women attending family
clinics were enrolled if they consented and were medically eligible to use Norplant,
IUD, or female sterilization. Women who chose to initiate use of IUDs or surgical
sterilization served as controls and were frequency matched in 5-year age-bands with
women who chose to use Norplant. At admission women had a physical examination, and
their medical histories, demographic, and socio-economic characteristics were recorded.
Follow-up visits were scheduled in the first 6 weeks after admission and semi-annually
thereafter for 5 years irrespective of change of contraceptive method. Incidence rate
ratios of health events were estimated for initial and current contraceptive method
use. This paper reports reproductive health events and contraceptive efficacy. Altogether,
7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of surgical sterilization
were admitted. Their mean ages at initiation were 28.5, 28.5, and 29.6 years, respectively.
More than 99% were married or cohabiting, and parous. Five-year follow-up was completed
by 94.6% of the women. By the end of 5 years, the mean duration of first segment use
per initiator was 4.16 years for Norplant, 4.10 years for IUDs, and 4.96 years for
sterilization accounting for 39,337 woman-years for Norplant, 31,915 for IUDs, and
7,071 for sterilization. The study accumulated 78,323 woman-years of observation.
Pearl pregnancy rates for Norplant, copper IUDs and female sterilization were 0.27,
0.88, and 0.17 per 100 woman-years, respectively. Users of Norplant, copper IUDs,
and sterilization had rates of ectopic pregnancy of 0.30, 0.68, and 0.13 per 1,000
woman-years, respectively. Major health events related to the reproductive system
were rare. Rates of acute PID were significantly lower among Norplant users than IUD
users (p = 0.004). The rate of ovarian enlargement was significantly higher in Norplant
users than controls (p <0.001), but not rates of hospitalization for this condition.
Vaginitis and vaginal discharge, and low abdominal pain were significantly less frequent
in Norplant users than in the other groups. Bleeding disturbances were more frequent
among Norplant users than controls but not anemia. The study confirms the high contraceptive
efficacy of Norplant, copper IUDs, and female sterilization. The incidence rates of
major reproductive health problems were low. There was no significant excess of serious
reproductive morbidity among users of Norplant compared to users of IUDs and sterilization.
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Article info
Publication history
Accepted:
January 15,
2001
Received in revised form:
January 9,
2001
Received:
February 28,
2000
Identification
Copyright
© 2001 Elsevier Science Inc. Published by Elsevier Inc. All rights reserved.
