Norplant, a progestagen implant designed to provide contraception for five years, was launched in the UK in October 1993. Almost 3 million women world wide are using it. The manufacturer claims that Norplant is "one of the most effective and practical forms of contraception for any woman who wants long-term reliability, convenience and the opportunity to change her mind". In this article we assess its use.

OBJECTIVE

To determine whether the process of ovulation could be interrupted by the insertion of Norplant implants (Leiras Pharmaceuticals, Turku, Finland) in the advanced preovulatory phase.

METHODS

Prospective study.

METHODS

The Department of Biomedical Research at the Family Planning Clinic of PROFAMILIA, Santo Domingo, Dominican Republic.

METHODS

Healthy women of reproductive age, requesting Norplant implants contraception. Thirteen of 15 women volunteers who were admitted completed the study.

METHODS

Norplant implants were inserted when the dominant follicle reached a mean diameter of 16 mm, based on serial vaginal ultrasounds (US) beginning on day 10 of the cycle. Blood samples for determination of E2, P, LH, and levonorgestrel, were taken and vaginal US performed at 0, 4, 24, 48, and 72 hours after insertion. If follicle rupture had not occurred at 72 hours after insertion, blood sampling and US were done three times per week during 2 additional weeks.

RESULTS

Follicle rupture occurred in 11 of 13 subjects within 72 hours after insertion, with the exception of 1 subject in whom rupture occurred between 72 and 192 hours. Two women already had an LH peak at the time of insertion. In 9 of the remaining 11 women, a shortlasting, blunted LH surge was observed at 4 hours postinsertion. In the remaining two women, who had the lowest E2 levels, ovulation was inhibited, and a persistent follicle developed without luteinization.

CONCLUSIONS

The insertion of Norplant implants in the advanced follicular phase will not inhibit ovulation if sufficient E2 priming has occurred. On the contrary, the exogenous progestin may rapidly foster ovulation shortly after.

A longitudinal study of coagulation parameters was carried out on 100 Singaporean acceptors using Norplant-2 rods for contraceptive purposes. At the end of 2 years of use, results from this study show a return of platelet count to preinsertion level while platelet aggregation remained significantly enhanced. Thus the net effect of these two changes on an increased tendency for thrombosis needs further evaluation. The PT and APTT continued to remain persistently shortened during the period of use. There was also a general fall in fibrinogen and most other coagulation factors during the two years of use. Thus, again, the net effect of these two changes on the exposed potential for hypercoagulation at the end of the first year needs further evaluation throughout the five years of Norplant-2 use.

There are currently four progestogens used in implantable contraceptives marketed or tested in clinical trials: levonorgestrel in Norplant and Jadelle, etonogestrel (3-keto-desogestrel) in Implanon, nestorone in Elcometrine, and nomegestrol acetate in Uniplant and Surplant. Each progestogen was evaluated for hormonal activity and for safety in a wide variety of tests in vitro and in animals prior to their use in women. All four progestogens underwent pre-clinical testing that generally followed the format for animal testing of steroidal contraceptives published by the World Health Organization and the US Food and Drug Administration (FDA). Most of the progestogens have been tested for genotoxicity in bacterial and mammalian cultured cells and in rodents. All were tested for toxicity in short- and long-term toxicology studies in rodents and dogs or monkeys, and all were tested for their effects on reproduction and fetal development. In most cases, the progestogens were tested for carcinogenicity in two rodent species, rats and mice. Early clinical trials in small numbers of women provided additional safety data prior to the exposure of large numbers of women in Phase 3 clinical trials. The published data and data submitted to the FDA demonstrate that the implantable progestogens have no significant or unusual toxicities and have a similar safety profile to the progestogens found in the approved oral contraceptives.

This study was conducted to determine any cardiovascular morbidity with Norplant use by electrocardiography. Thirty Nigerian women seeking long-term reversible contraception were recruited. The clients had baseline blood pressure checks and electrocardiography (ECG) tracings. These were repeated at the 12, 24 and 36 months follow-up visits and the results were analysed. The mean age of subjects was 32.4 +/- 3.98 years. The mean weight at pre-insertion and at the 12, 24 and 36 months follow-up visits showed a statistically significant rise after 2 years (p < 0.01). The blood pressures did not show any significant changes throughout the period of study. There was statistically significant prolongation of the PR and QRS intervals at the 12 month visit; mean PR interval (seconds) pre-insertion 0.153 +/- 0.003, and at 12 months 0.173 +/- 0.006 (P = 0.019), mean QRS interval (seconds) pre-insertion 0.056 +/- 0.003 and at 12 months 0.074 +/- 0.002 (P = 0.005). After 3 years of Norplant use, prolongation of the mean QRS interval remained evident (p = 0.011) while mean PR interval had returned to pre-insertion levels. There is a tendency to prolongation of PR and QRS (ECG) intervals in Norplant users; accordingly, it may be prudent for clients with cardiac conditions showing longer ECG intervals, to consider alternative methods of contraception.

OBJECTIVE

To determine the acceptance of Norplant implants while it was in use and share our experience with other Norplant providers.

METHODS

Retrospective descriptive study.

METHODS

The family planning clinic of the Jos University Teaching Hospital, Jos, Nigeria.

RESULTS

During the 21-year period, January 1985 to December 2005, a total of eighteen thousand, two hundred and ninety one (18,291) new clients accepted various modern contraceptive methods in the family planning clinic of Jos University Teaching Hospital, Nigeria. Norplant was accepted by 1,333 clients (4.9%) as against the intrauterine devices (IUDs) 25.4%, and Oral Contraceptive Pills (OCP) 22.9%. Female sterilisation was a contraceptive method of choice in 21.2%, the injectables in 13.9%, and the male condom in 9.3%. Failure rate was 0.37% and continuity rate was high among users. The Norplant contraceptive implant was accepted by women of mean age of 29.6 years and women of all parity. The acceptance pattern demonstrated a multi-nodal pattern from the time of introduction in 1985 to December 2005 when supply came to an abrupt stop. The greatest barriers to Norplant use were non- availability and high cost of the commodity.

CONCLUSIONS

Norplantimplants provided contraceptive protection with high reliability, safety, independence from user compliance, rapid return of pre-existing fertility after removal, good tolerability, and relatively simple and quick insertion and removal. The capsules will definitely be used as a reference for similar contraceptive products in the contraceptive market.

BACKGROUND

Modern contraceptive methods accepted by 17,846 new clients in Jos University Teaching Hospital, a tertiary health institution, over two decades are presented.

METHODS

This was a review of the contraceptive trend in new clients who used the various methods of contraception over an 18-year period, 1985-2002.

RESULTS

The accepted methods were the intrauterine device (26.1%), oral contraceptive pills (23.5%), female sterilization (21.7%), the Injectable (14.2%), male condom (9.5%), Norplant implants (4.9%) and vasectomy (0.1%). Reversible methods were used by 78.2% and the permanent forms by 21.8%. The women were the acceptors of the methods in 90.5%, while men contributed only 9.5% of the new acceptors. Ten men only had vasectomy over the period of study.

CONCLUSIONS

The Intrauterine device was the leading method of contraception accepted by the women and male vasectomy was the least accepted by men. There is the need for increased male involvement in contraceptive issues.

Experience with the contraceptive NORPLANT in Egypt dates back to early 1980 when the first multicentre trial was initiated. To date, more than 3000 women have received this contraceptive at the Assiut University Family Clinic alone. Analysis of the overall experience in this clinic has indicated a 5-year cumulative continuation rate of 51 and a pregnancy rate of 1.8 per 100 women. Clinical pharmacology studies pertaining to the safety of NORPLANT in our community have indicated no deleterious effect on the lipid profile, liver functions and blood coagulation system. Two studies conducted in Egypt have indicated that the initiation of NORPLANT use shortly after delivery does not have any unfavourable effect on lactational performance, or on physical or psychomotor development of the breast-fed infants. This is particularly important in Arab and Moslem cultures where prolonged breast-feeding is emphasized. A study utilizing focus-group discussion to assess users' attitudes to NORPLANT has indicated the need to improve the informational/educational package given in the service by emphasizing certain cultural considerations. On the whole, this first implant method has proven to be safe and acceptable in Egypt, where there is a special need for long-term methods for contraception, particularly as sterilization is not socially acceptable.

OBJECTIVE

Although Norplant implantable contraceptives were introduced first in Finland, their use has been infrequent. The objective of this study was to investigate what kind of women use Norplant in Finland, who suggested its use, and from what source women get their information on Norplant.

METHODS

A questionnaire was mailed to all women having had Norplant inserted one to two years before the study initiation (June 1992) in seven family-planning clinics in the Helsinki city area (n = 262). After one reminder, the response rate was 82%.

RESULTS

Most of the users were 25-34 years old, and many of them had had a previous abortion. Half of the women were still considering a (subsequent) child. All the women had used some birth control method before Norplant and reported several problems with it. Women reported that they themselves had chosen Norplant, but physicians and nursing staff in the family-planning clinic were their most important information sources. Most women considered that they had received sufficient information before insertion regarding both the good and bad aspects of the method.

CONCLUSIONS

Women with previous abortions are a special users' group for Norplant, even though most users are in no way exceptional women.

The Norplant contraceptive implant system is a commonly used method of contraception worldwide. Implant placement and removal are usually simple office-based outpatient procedures. Norplant removal can occasionally become difficult, usually secondary to improper insertion. In these instances, we describe a method of Norplant removal that can easily be performed with use of high-resolution fluoroscopy with associated digital subtraction imaging.