A prospective randomized comparison of sublingual and oral misoprostol when combined with mifepristone for medical abortion at 12–20 weeks gestation

• Published in: Human reproduction (Oxford) Vol. 20; no. 11; pp. 3062 - 3066
• Main Authors: Tang, Oi Shan, Chan, Carina C.W., Kan, Anita S.Y., Ho, Pak Chung
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.11.2005; Oxford Publishing Limited (England)
• Subjects: Abortifacient Agents, Nonsteroidal - administration & dosage; abortion; Abortion, Induced - methods; Administration, Oral; Administration, Sublingual; Adult; Biological and medical sciences; Double-Blind Method; Drug Therapy, Combination; Female; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Mifepristone - administration & dosage; misoprostol; Misoprostol - administration & dosage; Misoprostol - adverse effects; oral; Pregnancy; Pregnancy Trimester, Second; Prospective Studies; second trimester; sublingual; oral; abortion; second trimester; sublingual; misoprostol; Antineoplastic agent; Second trimester; Induced abortion; Oral administration; Antiulcer agent; abortion/misoprostol/oral/second trimester/sublingual; Antihormone; Misoprostol; Pregnancy; Vertebrata; Randomization; Mammalia; Abortifacient; Antisecretory agent; Antiprogesterone; Mifepristone; Comparative study; Prostaglandin derivatives
• ISSN: 0268-1161; 1460-2350
• DOI: 10.1093/humrep/dei196

BACKGROUND: Sublingual misoprostol has been shown to be effective in medical abortion. A prospective double-blinded placebo-controlled trial was done to compare the efficacy and side-effects of sublingual to oral misoprostol when used with mifepristone for medical abortion from 12 to 20 weeks gestation. METHODS: A total of 120 women at 12–20 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either sublingual or oral misoprostol 400 mg every 3 h for a maximum of five doses 36–48 h later. The course of misoprostol was repeated if the woman did not abort within 24 h. RESULTS: There was no significant difference (P = 0.43) in the success rate at 24 h [relative risk = 1.075; 95% confidence interval (CI): 0.94–1.19]. Abortion occurred in 91.4% in the sublingual group (95% CI: 81.0–96.7%) as compared to 85.0% (95% CI: 73.7–92.1%) in the oral group. The median induction-to-abortion interval was significantly shorter (P = 0.009) in the sublingual group (5.5 h) as compared to the oral group (7.5 h). The incidence of fever was higher in the sublingual group (P < 0.0001). The incidences of other side-effects were similar. CONCLUSION: Sublingual misoprostol, when combined with mifepristone, is effective for medical abortion in the second trimester. The induction-to-abortion interval is shorter when sublingual misoprostol is used when compared to oral misoprostol.