An estimated 900,000 pregnancies fail in the first trimester each year in the US. Traditionally, early pregnancy failure (EPF) has been treated by suction curettage, but prostaglandin analogues such as misoprostol may be an effective and safe alternative to surgery. This randomized trial enrolled 652 women with EPF at a gestational age of 13 weeks or less, who were randomly assigned in a 3:1 ratio to either receive 800 μg of misoprostol, inserted into the posterior vaginal fornix (n = 491), or undergo curettage by manual or electric vacuum aspiration (n = 161). All of those taking part in the trial were generally healthy and hemodynamically stable. They kept a bleeding diary for 2 weeks and were reassessed on or about day 15.
Baseline demographic features and the status of pregnancies were similar in the two treatment groups. Reduction in hemoglobin levels was greater in women given misoprostol than those having curettage (−0.7 gm/dL versus 0.2 gm/dL, P < 0.001). Also noted more often in misoprostol-treated women were a fall in hemoglobin of 2 gm/dL or greater and a nadir hemoglobin level less than 10 gm/dL. More women in the misoprostol group reported “any bleeding” or “heavy bleeding” on every day of the 2-week study period. It was not unusual for bleeding to continue beyond 2 weeks. Interviews on study 15 indicated that misoprostol recipients viewed bleeding as less acceptable than those who bled following curettage. In addition, women given misoprostol were likelier to seek further medical care for bleeding. Greater changes in hemoglobin after misoprostol were independently associated with increasing gestational age, parity, and younger maternal age. Nearly all adverse events related to bleeding were noted in women given misoprostol. Fifteen women in this group required curettage, and 4 required blood transfusion.
Despite causing more prolonged and heavier bleeding than suction curettage in women with EPF, misoprostol remains a safe alternative because intervention for bleeding is seldom necessary.
Creinin, for the National Institute of Child Health and Human Development Management of Early Pregnancy Failure Trial; Columbia University, New York, New York; Clinical Trials and Surveys Corp, Baltimore, Maryland; National Institute of Child Health and Human Development, National Institutes of Health, Division of Health and Human Services, Bethesda, Maryland; University of Miami, Miami, Florida; Penn Fertility Care and the Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia; and University of Pittsburgh and McGee Women’s Research Institute, Pittsburgh, Pennsylvania
Am J Obstet Gynecol 2007;196