Daniel Grossman1, Deborah Constant2, Naomi Lince-Deroche3, Jane Harries2, Judy Kluge4. 1. Ibis Reproductive Health, Oakland, CA; Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA. Electronic address: DGrossman@ibisreproductivehealth.org. 2. Women's Health Research Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa. 3. Ibis Reproductive Health, Johannesburg, South Africa (at the time of the study); Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. 4. Department of Obstetrics & Gynaecology, University of Stellenbosch and Tygerberg Hospital, Cape Town, South Africa.
Abstract
OBJECTIVE: To compare complication rates, efficacy and acceptability of buccal misoprostol to laminaria for cervical preparation before dilation and evacuation (D&E) in South Africa. STUDY DESIGN: We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1-2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13-19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power. RESULTS: Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0-18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20-5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostol participants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4-16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups. CONCLUSIONS: Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea. IMPLICATIONS: Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.
RCT Entities:
OBJECTIVE: To compare complication rates, efficacy and acceptability of buccal misoprostol to laminaria for cervical preparation before dilation and evacuation (D&E) in South Africa. STUDY DESIGN: We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1-2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13-19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power. RESULTS: Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0-18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20-5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostolparticipants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4-16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups. CONCLUSIONS: Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea. IMPLICATIONS: Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.
Authors: Naomi Lince-Deroche; Deborah Constant; Jane Harries; Judith Kluge; Kelly Blanchard; Edina Sinanovic; Daniel Grossman Journal: PLoS One Date: 2018-06-28 Impact factor: 3.240