Comparative satisfaction of receiving medical abortion service from nurses and auxiliary nurse-midwives or doctors in Nepal: results of a randomized trial.

BACKGROUND: Early first-trimester medical abortion (MA) service (≤ 63 days) has been provided by doctors and nurses under doctors' supervision since 2009 in Nepal. This paper assesses whether MA services provided by specifically trained and certified nurses and auxiliary nurse-midwives independently from doctors' supervision, is considered as satisfactory by women as those provided by doctors. METHODS: The data come from a multi-center, randomized, controlled equivalence trial conducted between April 2009 and March 2010 in five district hospitals in Nepal. Women seeking MA were randomly assigned to doctors or nurses and auxiliary nurse-midwives(ANMs).Eligible women were administered 200 mg mifepristone orally followed by 800 µg misoprostol vaginally two days later by their assigned providers and followed up 10-14 days later. At the follow-up visit women's reported satisfaction with MA service they received was measured. RESULTS: Of 1295 women screened for eligibility, 535 were randomly assigned to a doctor and 542 to a nurse or ANM. Nineteen women were lost-to-follow up in the former group and 27 were lost-to-follow up or did not complete the acceptability interview in the latter group. This study is, therefore, based on516womenin the doctor's group and 515 women in the nurse or ANM group. All women in the nurse or ANM group reported being satisfied or highly satisfied by MA compared to 99% in the doctor's group. Satisfaction was similar regardless of the type of provider; 38% among nurse or ANM and 35% among the doctor group were "highly satisfied", and 62% and 64%, respectively, were "satisfied". Women's experiences such as 'less than expected amount or duration of bleeding following MA', 'shorter than expected duration of the abortion process', and 'able to manage symptoms', were found to be associated with women's higher satisfaction with MA. Counseling and information on the method, potential complications of MA and post-abortion contraception was nearly universal. No statistically significant differences were found in the level of satisfaction by age, parity, marital status, education or occupation of women. CONCLUSIONS: Women's satisfaction with MA service provided by trained nurses or auxiliary nurse-midwives was similar to that provided by doctors. The findings, therefore, provide support for extending safe and accessible medical abortion services by government-trained nurses and auxiliary nurse midwives to women seeking early first trimester pregnancy termination. TRIAL REGISTRATION: The trial was retrospectively registered with ClinicalTrials.gov (identifier: NCT01186302 ). Registered August 20, 2010.

Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A.

OBJECTIVES: To compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) intrauterine device (LNG-IUD) or the copper T 380 A IUD (TCu380A). STUDY DESIGN: This was an open-label 7-year randomized controlled trial in 20 centres, 11 of which in China. Data on 1884 women with interval insertion of the LNG-IUD and 1871 of the TCu380A were analysed using life tables with 30-day intervals and Cox proportional hazards models. RESULTS: The cumulative 7-year pregnancy rate of the LNG-IUD was 0.5 (standard error 0.2) per 100, significantly lower than 2.5 (0.4) per 100 of the TCu380A, cumulative method discontinuation rates at 7 years were 70.6 (1.2) and 40.8 (1.3) per 100, respectively. Dominant reasons for discontinuing the LNG-IUD were amenorrhea (26.1 [1.3] per 100) and reduced bleeding (12.5 [1.1] per 100), particularly in Chinese women and, for the TCu380A, increased bleeding (9.9 [0.9] per 100), especially among non-Chinese women. Removal rates for pain were similar for the two intrauterine devices (IUDs). Cumulative rates of removal for symptoms compatible with hormonal side effects were 5.7 (0.7) and 0.4 (0.2) per 100 for the LNG-IUD and TCu380A, respectively, and cumulative losses to follow-up at 7 years were 26.0 (1.4) and 36.9 (1.3) per 100, respectively. CONCLUSION: The LNG-IUD and the TCu380A have very high contraceptive efficacy, with the LNG-IUD significantly higher than the TCu380A. Overall rates of IUD removals were higher among LNG-IUD users than TCu380A users. Removals for amenorrhea appeared culturally associated. IMPLICATIONS: The 52-mg LNG-IUD and the TCu380A have very high contraceptive efficacy through 7 years. As an IUD, the unique side effects of the LNG-IUD are reduced bleeding, amenorrhea and symptoms compatible with hormonal contraceptives.

A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.

STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN, SIZE, DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. PARTICIPANTS, SETTING, METHODS: The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of ≥70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5), and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2), respectively. Bleeding disturbances, the most frequent reason for method discontinuation, were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group, 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1), respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P < 0.0001). In the observational comparison between IUD and implant users, the 3-year relative risk for pregnancy in IUD group compared with the combined implant group was 5.7 per 100 W-Y (95% CI 4.4-7.3) (P = 0.0003). The 3-year expulsion rate of the IUD was 17.8 per 100 W-Y (95% CI 14.5-21.9), while the discontinuation rate for bleeding disturbances was 8.5 (95% CI 6.7-10.9). Frequency of complaints of headache and dizziness was not significantly different between implant and IUD users (P = 0.16 and 0.77, respectively), acne and bleeding irregularities were more frequent among implant users (P < 0.0001), while heavy bleeding and lower abdominal pain occurred more often among IUD than implant users (P < 0.0001). LIMITATIONS, REASONS FOR CAUTION: Few women were ≤19 years old or nulligravida, the proportion of implant users ≥70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant, but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003.

A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data.

BACKGROUND: Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. STUDY DESIGN: A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. RESULTS: A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8% and 0.2%; and at follow-up, 27.2% and 26.7% of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1% of IUDs were expelled. CONCLUSION: Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A.

Complications of first-trimester abortion by vacuum aspiration after cervical preparation with and without misoprostol: a multicentre randomised trial.

BACKGROUND: Little information is available about the incidence of complications from vacuum aspiration for first-trimester abortion after cervical preparation with prostaglandin analogues. We compared incidence of complications from vacuum aspiration in women who had had cervical preparation with misoprostol and those who had not. METHODS: We did a randomised parallel-group trial at 14 centres in nine countries between Oct 22, 2002, and Sept 24, 2005. Healthy women seeking first-trimester abortion were randomly assigned via a computer-generated randomisation sequence stratified by centre, to receive vaginal administration of either two 200 µg tablets of misoprostol or two placebo tablets 3 h before abortion by vacuum aspiration. Participants and health-care personnel other than staff administering the treatment were masked to group assignment. Follow-up was up to 2 weeks. The primary outcome was one or more complications of vacuum aspiration (cervical tear, uterine perforation, incomplete abortion, uterine re-evacuation, pelvic inflammatory disease, or any other serious adverse event). We included women undergoing treatment and vacuum aspiration in the analysis of immediate complications; whereas, in the analysis of delayed complications, we included only those followed-up. In the analysis of any immediate or delayed complication, we excluded women lost to follow-up. This trial is registered, number ISRCTN85366519. FINDINGS: We randomly assigned 2485 women to the misoprostol group and 2487 to the placebo group. Two women in the misoprostol group did not have vacuum aspiration. 56 women in each group were lost to follow-up. 50 (2%) of 2427 women in the misoprostol group and 74 (3%) of 2431 in the placebo group had one or more complication of vacuum aspiration (relative risk [RR] 0·68, 95% CI 0·47-0·96). No women in the misoprostol group had cervical tears and three had uterine perforations compared with two women in the placebo group who had cervical tears and one who had perforation. 19 (<1%) women given misoprostol and 55 (2%) on placebo had incomplete abortions (0·35, 0·21-0·58), of whom 14 (<1%) versus 48 (2%) needed uterine re-evacuation (0·29, 0·16-0·53). We noted no difference between groups in incidence of pelvic inflammatory disease (30 [1%] vs 25 [1%]; RR 1·20, 0·71-2·04) or other serious adverse events. The main side-effects of misoprostol during the 3 h treatment were abdominal pain (1355 [55%] of 2484 women vs 545 [22%] of 2487 women in the placebo group) and vaginal bleeding (909 [37%] vs 167 [7%]). INTERPRETATION: Cervical preparation with 400 µg of vaginal misoprostol can reduce incidence of complications from vacuum aspiration for first trimester abortion. FUNDING: UN Development Programme/UN Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO, and the Packard Foundation.

Provision of DMPA by community health workers: what the evidence shows.

BACKGROUND: To reduce a large unmet need for family planning in many developing countries, governments are increasingly looking to community health workers (CHWs) as an effective service delivery option for health care and as a feasible option to increase access to family planning services. This article synthesizes evidence on the feasibility, safety and effectiveness of community-based delivery of the injectable contraceptive depot-medroxyprogesterone acetate (DMPA). STUDY DESIGN: Manual and electronic search and systematic review of published and unpublished documents on delivery of contraceptive injectables by CHWs. RESULTS: Of 600 identified documents, 19 had adequate information on injectables, almost exclusively intramuscular DMPA, provided by CHWs. The data showed that appropriately trained CHW demonstrate competency in screening clients, providing DMPA injections safely and counseling on side effects, although counseling appears equally suboptimal in both clinic and community settings. Clients and CHWs report high rates of satisfaction with community-based provision of DMPA. Provision of DMPA in community-based programs using CHWs expanded access to underserved clients and led to increased uptake of family planning services. CONCLUSIONS: We conclude that DMPA can be provided safely by appropriately trained and supervised CHWs. The benefits of community-based provision of DMPA by CHWs outweigh any potential risks, and past experiences support increasing investments in and expansion of these programs.

Can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal.

BACKGROUND: Medical abortion is under-used in developing countries. We assessed whether early fi rst-trimester medical abortion provided by midlevel providers (government-trained, certified nurses and auxiliary nurse midwives) was as safe and effective as that provided by doctors in Nepal. METHODS: This multicentre randomised controlled equivalence trial was done in fi ve rural district hospitals in Nepal. Women were eligible for medical abortion if their pregnancy was of less than 9 weeks (63 days) and if they resided less than 90 min journey away from the study clinic. Women were ineligible if they had any contraindication to medical abortion. We used a computer-generated randomisation scheme stratified by study centre with a block size of six. Women were randomly assigned to a doctor or a midlevel provider for oral administration of 200 mg mifepristone followed by 800 µg misoprostol vaginally 2 days later, and followed up 10-4 days later. The primary endpoint was complete abortion without manual vacuum aspiration within 30 days of treatment. The study was not masked. Abortions were recorded as complete, incomplete, or failed (continuing pregnancy). Analyses for primary and secondary endpoints were by intention to treat, supplemented by per-protocol analysis of the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT01186302. FINDINGS: Of 1295 women screened, 535 were randomly assigned to a doctor and 542 to a midlevel provider. 514 and 518, respectively, were included in the analyses of the primary endpoint. Abortions were judged complete in 504 (97.3%) women assigned to midlevel providers and in 494 (96.1%) assigned to physicians. The risk difference for complete abortion was 1.24% (95% CI -0.53 to 3.02), which falls within the predefined equivalence range (-5% to 5%). Five cases (1%) were recorded as failed abortion in the doctor cohort and none in the midlevel provider cohort; the remaining cases were recorded as incomplete abortions. No serious complications were noted. INTERPRETATION: The provision of medical abortion up to 9 weeks' gestation by midlevel providers and doctors was similar in safety and effectiveness. Where permitted by law, appropriately trained midlevel health-care providers can provide safe, low-technology medical abortion services for women independently from doctors. FUNDING: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization.

The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial.

BACKGROUND: Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared. STUDY DESIGN: Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years. RESULTS: Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI: 4.4-6.4) per 100 and 2.5 (95% CI: 1.9-3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9-2.0) and 0.5 (95% CI: 0.3-0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI: 0.7-1.9) and 2.5 (95% CI: 1.8-3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different. CONCLUSIONS: The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.

Prostate cancer and vasectomy: a hospital-based case-control study in China, Nepal and the Republic of Korea.

BACKGROUND: The study of a possible relationship between vasectomy and prostate cancer has yielded mixed results. Data from developing countries are limited. STUDY DESIGN: We conducted a hospital-based case-control study in China, Nepal and the Republic of Korea to evaluate the risk of prostate cancer after vasectomy. RESULTS: Prostate cancer in 294 cases (confirmed by independent pathologists) and 879 matched controls were included. The odds ratio of prostate cancer in men with a history of vasectomy was 1.21 [95% confidence interval (95% CI)=0.79, 1.87]. No significant trend was observed in risk by time since vasectomy or age at vasectomy. The odds ratio for localized disease was 1.02 (95% CI=0.53, 1.95); the odds ratio for later stages was 1.41 (95% CI=0.78, 2.53). No confounding factor was identified. The study illustrated differential misclassification of disease by vasectomy status; reference pathologists determined that 28% of men with a history of vasectomy, compared with 17% of men without a history of vasectomy, were misdiagnosed with prostate cancer by local pathologists. CONCLUSION: Vasectomy is not associated with an increased risk of prostate cancer in developing countries where the rate of the disease is low.

Intrauterine devices - upper and lower genital tract infections.

The clinical diagnosis of a pelvic inflammatory disease (PID) is notoriously difficult. The incidence rate of PIDs among intrauterine device (IUD) users as reported from different studies depends heavily on the definition used and the means available for diagnosing PIDs. It varies by almost 10-fold from 1 per 100 to 1 per 1000 woman-years in different publications. PID risk has been found to be 6-fold higher in the first month after IUD insertion than it is thereafter. It is not known if the overall PID risk in IUD users beyond the first month of IUD insertion is higher than that in nonusers; however, if it is higher, the additional risk is small. The PID risk in IUD users is modified by the number of sexual partners of the IUD user and that of her partner(s), community prevalence of STDs and age of the IUD user. Bacterial vaginosis appears not to be associated with IUD use. Overall, bacterial vaginosis is not associated with PIDs, but specific subgroups of patients with BV that may be difficult to identify clinically are at an increased risk for PIDs. Because of the long duration of use of current copper IUDs, replacement of the IUD is infrequent and insertion-associated PIDs should consequently also be less frequent. IUD use has become safer with respect to PIDs through more effective screening and counseling procedures described in current guidelines for the initiation of IUD use. Current guidance must be followed to preserve the IUD as a safe contraceptive method.

Once-a-month contraceptive pills in China: a review of available evidence.

OBJECTIVE: A review of evidence was conducted to assess the safety, effectiveness and continuation of once-a-month contraceptive pills. METHODS: Papers were identified by electronic searches in Chinese and international databases and manual searches of Chinese journals and index of family planning literature. Data on pharmacokinetics, clinical performance and laboratory examinations were extracted from 17 papers of mixed quality on pills containing quinestrol 3 mg and norgestrel 12 mg (Quin-Ng) or levonorgestrel 6 mg (Quin-Lng) used by women in China. RESULTS: Quin-Lng pills gave steady-state serum levels of ethinylestradiol between 0.20-0.25 and 0.15 ng/mL. The 1-year perfect use pregnancy rate was 1.1 per 100 women-years. Nausea and increased leukorrhea were common; bleeding control was good. Hypertension developed in 5.8% of Quin-Ng pill users during the first year of use. For Quin-Ng and Quin-Lng once-a-month pills, 1 year continuation rates were 73.6 and 82.1 per 100, respectively. CONCLUSIONS: Lack of good quality data prevents confident assessment of the safety and efficacy of once-a-month pills. Short-term safety information indicates a high incidence of bothersome side effects and hypertension. The high monthly estrogen and progestogen doses raise questions about the safety of the once-a-month pills.

Female genital mutilation and obstetric outcome: WHO collaborative prospective study in six African countries.

BACKGROUND: Reliable evidence about the effect of female genital mutilation (FGM) on obstetric outcome is scarce. This study examines the effect of different types of FGM on obstetric outcome. METHODS: 28 393 women attending for singleton delivery between November, 2001, and March, 2003, at 28 obstetric centres in Burkina Faso, Ghana, Kenya, Nigeria, Senegal, and Sudan were examined before delivery to ascertain whether or not they had undergone FGM, and were classified according to the WHO system: FGM I, removal of the prepuce or clitoris, or both; FGM II, removal of clitoris and labia minora; and FGM III, removal of part or all of the external genitalia with stitching or narrowing of the vaginal opening. Prospective information on demographic, health, and reproductive factors was gathered. Participants and their infants were followed up until maternal discharge from hospital. FINDINGS: Compared with women without FGM, the adjusted relative risks of certain obstetric complications were, in women with FGM I, II, and III, respectively: caesarean section 1.03 (95% CI 0.88-1.21), 1.29 (1.09-1.52), 1.31 (1.01-1.70); postpartum haemorrhage 1.03 (0.87-1.21), 1.21 (1.01-1.43), 1.69 (1.34-2.12); extended maternal hospital stay 1.15 (0.97-1.35), 1.51 (1.29-1.76), 1.98 (1.54-2.54); infant resuscitation 1.11 (0.95-1.28), 1.28 (1.10-1.49), 1.66 (1.31-2.10), stillbirth or early neonatal death 1.15 (0.94-1.41), 1.32 (1.08-1.62), 1.55 (1.12-2.16), and low birthweight 0.94 (0.82-1.07), 1.03 (0.89-1.18), 0.91 (0.74-1.11). Parity did not significantly affect these relative risks. FGM is estimated to lead to an extra one to two perinatal deaths per 100 deliveries. INTERPRETATION: Women with FGM are significantly more likely than those without FGM to have adverse obstetric outcomes. Risks seem to be greater with more extensive FGM.

Mifepristone-induced early abortion and outcome of subsequent wanted pregnancy.

Follow-up information on subsequent pregnancies after mifepristone (RU486)-induced abortion is scarce. The authors examined whether one mifepristone-induced first-trimester abortion affects the outcome of a subsequent wanted pregnancy. In a study conducted in 1998-2001 at antenatal clinics in Beijing, Chengdu, and Shanghai, China, the authors enrolled 4,925 women with no history of induced abortion, 4,931 women with one previous mifepristone-induced abortion, and 4,800 women with one previous surgical abortion and followed them through pregnancy and childbirth. The adjusted odds ratio for preterm delivery in women with one mifepristone abortion compared with women with no abortion was 0.77 (95% confidence interval: 0.61, 0.98). Although the mean birth weight of infants born to women with mifepristone abortion was 33 g (95% confidence interval: 17, 49) higher than that of infants born to women with no abortion, the frequencies of low birth weight and mean lengths of pregnancy were similar. There were no significant differences in risk of preterm delivery, frequency of low birth weight, or mean infant birth weight in the comparisons of women with previous mifepristone abortion and women with surgical abortion. This study suggests that one early abortion induced by mifepristone in nulliparous women has no adverse effects on the outcome of a subsequent pregnancy.

Implantable contraceptives for women.

Progestogen-only implantable contraceptives are used by increasing numbers of women worldwide. This review outlines the evidence accumulated on these methods to date. Reviews of toxicological evaluations, clinical trials, endocrinological, epidemiological and social science studies, as well as operations research and economic evaluation were undertaken in preparation for an Expert Consultation convened by the World Health Organization in 2001. At the meeting, these reviews were further evaluated and the research results summarized in this consensus paper. A large body of evidence demonstrates the high contraceptive effectiveness and safety of the 5-year levonorgestrel-releasing implants Norplant and Jadelle. Information on the 3-year etonogestrel-releasing implant Implanon is more limited, but suggests that this implant has a high contraceptive effectiveness and a satisfactory safety profile. Information available on levonorgestrel-releasing implants manufactured and approved in China suggests that their clinical performance is satisfactory, but was insufficient to allow their full safety assessment. For all implants, there is insufficient information on their use by women with medical conditions. Provision of contraceptive implants requires good quality family planning services and specific provider training.