title: A randomized trial of misoprostol versus laminaria before dilation and evacuation in 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: 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.
authors.forename: Daniel
authors.initials: D
authors.lastname: Grossman
authors.affiliation: Women's Health Research Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Deborah
authors.initials: D
authors.lastname: Constant
authors.affiliation: 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.
authors.forename: Naomi
authors.initials: N
authors.lastname: Lince-Deroche
authors.affiliation: Women's Health Research Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Jane
authors.initials: J
authors.lastname: Harries
authors.affiliation: Department of Obstetrics & Gynaecology, University of Stellenbosch and Tygerberg Hospital, Cape Town, South Africa.
authors.forename: Judy
authors.initials: J
authors.lastname: Kluge
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage / Q000009:adverse effects; D000028:Abortion, Induced / Q000009:adverse effects*; D000278:Administration, Buccal; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000187:drug effects*; D003967:Diarrhea / Q000139:chemically induced; D004106:Dilatation / Q000009:adverse effects; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007795:Laminaria; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects; D017060:Patient Satisfaction; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011262:Pregnancy Trimester, Second; D011292:Premedication / Q000009:adverse effects*; D012646:Self Administration; D016037:Single-Blind Method; D013019:South Africa; D014619:Vacuum Curettage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol
keywords: Abortion; Cervical priming; Midtrimester; Second trimester