Fetal malformation and failed medical termination of pregnancy

Abstract

Claudette Gonzalez and colleagues (May 30, p 1624)1Gonzalez CH Marques-Dias MJ Kim CA et al.Congenital abnormalities in Brazilian children associated with misoprostol misuse in first trimester of pregnancy.Lancet. 1998; 351: 1624-1627Summary Full Text Full Text PDF PubMed Scopus (205) Google Scholar describe birth defects after failed illegal abortion in 42 infants who were exposed to misoprostol at doses of 200–1600 μg during the first 3 months of gestation. This report underscores both the risk of misuse of misoprostol used as a sole agent to procure abortion and the social consequences of the restrictive laws on abortion in Brazil. Misoprostol is registered for use in association with mifepristone for legal termination of early pregnancy (up to 49 days of gestation) in France. The licensed regimen has proved over 95% effective in inducing complete abortion.2Peyron R Aubeny E Targosz V et al.Early termination of pregnancy with mifepristone (RU486) and the orally active prostaglandin misoprostol.N Engl J Med. 1993; 328: 1509-1513Crossref PubMed Scopus (317) Google Scholar In the UK and Sweden, the prostaglandin PgE1 analogue gemeprost is registered for use in association with mifepristone for termination of early pregnancy of up to 63 days'gestation, and efficacy has been shown to be about 95%.3UK multicentre study groupThe efficacy and tolerance of mifepristone and prostaglandin in termination of pregnancy of less than 63 days gestation; UK multicentre study–final results.Contraception. 1997; 55: 1-5Summary Full Text PDF PubMed Scopus (74) Google Scholar The regimens of oral misoprostol or vaginal gemeprost in association with mifepristone are associated with a complete failure rate of between 1·5% and 0·3%, respectively.2Peyron R Aubeny E Targosz V et al.Early termination of pregnancy with mifepristone (RU486) and the orally active prostaglandin misoprostol.N Engl J Med. 1993; 328: 1509-1513Crossref PubMed Scopus (317) Google Scholar, 3UK multicentre study groupThe efficacy and tolerance of mifepristone and prostaglandin in termination of pregnancy of less than 63 days gestation; UK multicentre study–final results.Contraception. 1997; 55: 1-5Summary Full Text PDF PubMed Scopus (74) Google Scholar The Exelgyn (the French company set up by ES to further develop and market Mifegyne [mifepristone] outside the USA) datasheet indicates that it is essential that termination of pregnancy by another method be undertaken in the event of failure. Nevertheless, if a woman changes her mind or the clinician fails to follow-up or make a diagnosis, some pregnancies will continue. We reviewed 71 cases of continuing pregnancy after failed early medical termination of pregnancy. The cases occurred between 1987 and 1998, and in that time we estimate that about 405 000 early medical terminations of pregnancy had been done in the UK, France, and Sweden. In 21 of these cases mifepristone was used alone, in the remaining cases mifepristone was associated with a prostaglandin analogue: misoprostol 400 μg orally (22), sulprostone 0·25–0·5 mg intramuscularly (four), gemeprost 1 mg vaginally (ten), and an unspecified prostaglandin (14). In eight of the 71 cases, malformation of the fetus or baby was reported. The table shows details of the drug regimen used, age of pregnancy, and outcome in those for whom abnormality was reported. There were no reported cases of malformation associated with use of misoprostol when used with mifepristone.TableFetal malformation associated with failed medical termination of pregnancyCaseGestatiionMif dose(mg)PG typeOutcomeDefect17 weeks400NoneTToPSirenomelia, cleft palate28 weeks600GemeprostABNBilateral talipes equinovares39 weeks 2 days600GemeprostABNFingernail defect 348 weeks600GemeprostTToPTalipes equinovares59 weeks600GemeprostTToPAcheiria, talipes equinovares67–8 weeks600GemeprostTToPAnencephalia, talipes equinovares78 weeks 4 days600GemeprostABNHeart malformation86–7 weeks200GemeprostTToPCerebrellum atrophyMif=mifepristone, Pg=prostaglandin, TToP=therapeutic termination of pregnancy, ABN=abnormality at term. Open table in a new tab Mif=mifepristone, Pg=prostaglandin, TToP=therapeutic termination of pregnancy, ABN=abnormality at term. Our findings show the safety of legal, early, medical termination of pregnancy in association with mifepristone and prostaglandin, but also provide information on the risk associated with continuing a pregnancy to term after a failure of the method. The apparent risk should be viewed with respect to the rate of spontaneous fetal malformation or non-viability, which might be as high as 34% at the stage of gestation appropriate for early medical termination of pregnancy.4Blanch G Quenby S Ballantyne ES et al.Embryonic abnormalities at medical termination of pregnancy with mifepristone and misoprostol during first trimester: observational study.BMJ. 1998; 316: 1712-1713Crossref PubMed Scopus (20) Google Scholar We emphasise the need for rigorous adherence of the recommended procedure and counselling of women who change their minds about termination after a failed medical procedure should be undertaken to explain the possible risks to the fetus and the high rate of naturally occurring abnormalities that may lead to later miscarriage or non-viability.