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Daily Low Dose Mifepristone Has Contraceptive Potential By J Fam Plann Reprod Health Care: first published as 10.1783/147118902101196441 on 1 July 2002. Downloaded from Journal Club women discontinued due to problems with included Medline; Popline, the Cochrane infections (STIs), chlamydia and gonorrhoea in compliance to the study. Although women were Controlled Trials Register and EMBASE. Of the particular. Rates of expulsion, perforation, not randomised, statistical tests showed both 12 randomised trials identified, one was infection and failure were comparable to IUD groups were similar with respect to demographic excluded due to non-randomisation, one was insertion at other times. A follow-up details of women and infants. The results excluded as it did not identify the main outcomes appointment for an IUD check is essential. This indicated there was no significant difference in of this review, and two were excluded due to study has highlighted the need for prospective mean volume of milk produced between the two design faults and unethical practice. Women of studies of currently used copper devices, and groups. Milk volume was measured as pre- and any age and gravity were included. All trials indeed hormonal intrauterine systems. post-feed infant weight, over 24 hours as is the included had been carried out in the 1970s and standard method of assessment. The composition 1980s. The two largest and most Reviewed by Dr Susan Brechin, DFFP, MRCOG of milk was similar in both groups in terms of methodologically sound World Health Subspecialty Trainee Sexual and Reproductive triglyceride, protein and lactose content. It was Organization (WHO) studies, which included Health, The Sandyford Initiative, Glasgow, UK calculated that the suckling infant received a 4476 women-years of data, were both carried out maximum of 0.01–0.05 µg/kg/day desogestrel. almost 20 years ago in 1983. The IUDs used This accounts for 2.6–3.7% of the daily maternal during these studies included the Copper 7, Mifepristone as a contraceptive dose. No significant differences were noted in Lippes Loop and the Copper T220. agent weight, length and biparietal diameter up to the The following rates were obtained from the two seventh cycle of treatment. When infants were WHO studies. Insertion of an IUD immediately Daily low dose mifepristone has contraceptive followed up at 18 and 30 months there were no following therapeutic abortion was associated potential by suppressing ovulation and clinically relevant differences between the two with: perforation rates of 1 per 1000 insertions menstruation: a double blind randomized groups. The authors conclude that 75 µg (3/2348 cases); expulsion rates of 7% (157 control trial of 2 mg and 5 mg per day for 120 desogestrel progestogen-only pill is a safe and expulsions); failure rates of 2 per 100 woman days. Brown A, Cheng L, Suiqing L, et al. J Clin effective method of contraception for lactating years (this included 70 intrauterine and Endocrinol Metab 2002; 87: 63–70 women. Efficacy cannot be concluded from the extrauterine pregnancies); and rates of pelvic study as pregnancy rates were not reported, infection (PID) of 0.4 per 100 woman years (12 It has previously been demonstrated that however the authors refer to the effectiveness of cases of PID). Insertion of an IUD immediately antiprogestins have contraceptive potential. This the desogestrel pill from published data where following spontaneous abortion was associated current study is a double-blind randomised desogestrel is known to inhibit ovulation and has with: perforation rates of 0.9 per 1000 insertions control trial (RCT) of daily mifepristone (2 mg a 12-hour window for missed pills. Bias may (1 in 1060 insertions); expulsion rates of 0.9% versus 5 mg) for 120 days. It was conducted in have been introduced due to the non- (128 expulsions); failure rates of 2 per 100 Edinburgh (58 subjects) and Shanghai (40 randomisation of women and also because woman years (21 intrauterine pregnancies); and subjects). In addition to examining effects on neither patient nor researchers were blinded. It is rates of PID of 0.2 per 100 women years (three ovulation and bleeding, contraceptive efficacy unclear if laboratory staff were blinded. cases of PID). The authors also noted that the was examined in a subgroup of 50 subjects who However, automated testing was used to identify risk of expulsion increased with increasing used it as their sole method of contraception. milk composition. The safety of the desogestrel gestational age, with rates increasing 4.5-fold Both 2 mg and 5 mg of mifepristone suppressed pill for lactating women has been demonstrated from first to second trimester abortion. ovulation (90% and 95%, respectively) and in this study. There were a number of factors that could induced amenorrhoea in the majority of cycles have introduced bias. Many of the studies (65% and 88%, respectively), although this was Reviewed by Dr Susan Brechin, DFFP, MRCOG included were more than 20 years old and in that a more consistent finding with the 5 mg dose. Subspecialty Trainee in Sexual and Reproductive time clinical practice has changed. The IUDs Even in cycles in which ovulation did occur, the Health, The Sandyford Initiative, Glasgow, UK used in these studies are not used today. Only histology of the endometrium was such that it one IUD included had doses of copper would be unlikely to support a pregnancy. comparable to IUDs in use today which often Furthermore, there were no pregnancies amongst Intrauterine device insertion contain 380 mm2 of copper. This may affect the 50 subjects in over 200 months of exposure. following abortion efficacy data presented since those devices with Despite prolonged anovulation with continued higher levels of copper have lower failure rates oestrogen secretion, it is reassuring that end-of- Insertion of an intrauterine contraceptive than do those with low doses of copper or inert study endometrial biopsies displayed no device after induced or spontaneous abortion: devices. Problems interpreting the results from evidence of hyperplasia or atypia. Few side a review of the evidence. Stanwood NL, Grimes these studies to our present clinical practice may effects were reported and menses resumed DA, Schulz KF. Br J Obstet Gynaecol 2001; arise as a result of a number of factors. The within 3 weeks of cessation of treatment. http://jfprhc.bmj.com/ 108: 1168–1173 majority of women included in the studies Interestingly, Chinese subjects proved more underwent surgical termination of pregnancy sensitive to mifepristone as they experienced The purpose of this systematic review was to (STOP), rather than medical termination of greater ovarian suppression and a higher assess the safety and efficacy of immediate post- pregnancy with prostaglandins (MTOP). This incidence of amenorrhoea. This may be related abortal intrauterine contraceptive device (IUD) may influence the incidence of post-abortal to their lower body mass index (BMI) or dietary insertion. The introduction clearly outlined infection in the study population. The authors effects on the enterohepatic circulation of potential benefits of immediate IUD insertion: concluded that IUD insertion immediate post- steroids. Importantly, this study provides providing immediate contraception when the therapeutic or spontaneous abortion was safe and medium-term data to support the potential of woman’s motivation is high, and the avoidance effective. Rates of pelvic infection (PID), one of mifepristone (2 mg or 5 mg) as a daily on September 30, 2021 by guest. Protected copyright. of the discomfort associated with insertion. the main outcomes measured, may differ in these contraceptive pill, by inhibiting ovulation and/or Disadvantages of immediate IUD insertion may older studies to the rates today. Rates of PID may through effects on the endometrium. This include: increased risk of perforation; increased be reduced by: increasing the numbers of women oestrogen-free alternative to the progestogen- risk of expulsion; increased risk of pelvic undergoing medical termination of pregnancy, only-pill would also have the advantage of infection; and possibly reduced efficacy. The thus avoiding uterine instrumentation; active amenorrhoea. Larger studies of long-term authors comprehensively and systematically screening for sexually transmitted disease pre- duration are now needed. reviewed randomised controlled trials (RCTs), in termination; and the use of prophylactic which at least one arm involved the insertion of antibiotic policies. The rates of infection may Reviewed by Dr Sharon Cameron, MD, MRCOG an IUD immediately after spontaneous or increase, however, due to the increasing Lecturer/Subspecialty Trainee in Reproductive therapeutic abortion. Databases searched background rates of sexually transmitted Medicine, University of Edinburgh, UK 166 The Journal of Family Planning and Reproductive Health Care 2002: 28(3).
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