Hum. Reprod. Advance Access originally published online on September 14, 2008
Human Reproduction 2009 24(1):106-112; doi:10.1093/humrep/den328
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Comparison of vaginal and sublingual misoprostol for second trimester abortion: randomized controlled equivalence trial
1 UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, 1211 Geneva 27, Switzerland 2 Centro Rosarino de Estudios Perinatales, Rosario, Argentina 3 Karolinska Institutet, Stockholm, Sweden 4 Research Center of Maternal and Child Health Protection, Yerevan, Armenia 5 Zhordania Institute of Human Reproduction, Tbilisi, Georgia 6 University of Szeged, Szeged, Hungary 7 All India Institute of Medical Sciences, New Delhi, India 8 SAT Hospital, Trivandrum, India 9 National Institute for Research in Reproductive Health, Indian Council of Medical Research and Sir JJ Group of Hospitals, Mumbai, India 10 University Department of Obstetrics and Gynaecology, Ljubljana, Slovenia 11 Reproductive Health and HIV Research Unit, Soweto, South Africa 12 Institute for the Protection of Mother and Newborn, Hanoi, Vietnam 13 Hanoi Obstetrics and Gynaecology Hospital, Hanoi, Vietnam 14 Tu Du Hospital, Ho Chi Minh City, Vietnam
15 Correspondence address. E-mail: helena.vonhertzen{at}gmail.com
BACKGROUND: To identify an effective misoprostol-only regimen for the termination of second trimester pregnancy, we compared sublingual and vaginal administration of multiple doses of misoprostol in a randomized, placebo-controlled equivalence trial.
METHODS: Six hundred and eighty-one healthy pregnant women requesting medical abortion at 13–20 weeks' gestation were randomly assigned within 11 gynaecological centres in seven countries into two treatment groups: 400 µg of misoprostol administered either sublingually or vaginally every 3 h up to five doses, followed by sublingual administration of 400 µg misoprostol every 3 h up to five doses if abortion had not occurred at 24 h after the start of treatment. We chose 10% as the margin of equivalence. The primary end-point was the efficacy of the treatments to terminate pregnancy in 24 h. Successful abortion within 48 h was also considered as an outcome along with the induction-to-abortion-interval, side effects and women's perceptions on these treatments.
RESULTS: At 24 h, the success (complete or incomplete abortion) rate was 85.9% in the vaginal administration group and 79.8% in the sublingual group (difference: 6.1%, 95% CI: 0.5 to 11.8). Thus, equivalence could not be concluded overall; the difference, however, was driven by the nulliparous women, among whom vaginal administration was clearly superior to sublingual administration (87.3% versus 68.5%), whereas no significant difference was observed between vaginal and sublingual treatments among parous women (84.7% versus 88.5%). The rates of side effects were similar in both groups except for fever, which was more common in the vaginal group. About 70% of women in both groups preferred sublingual administration.
CONCLUSIONS: Equivalence between vaginal and sublingual administration could not be demonstrated overall. Vaginal administration showed a higher effectiveness than sublingual administration in terminating second trimester pregnancies, but this result was mainly driven by nulliparous women. Fever was more prevalent with vaginal administration. Registered with International Standard Randomized Controlled Trial number ISRCTN72965671 [controlled-trials.com] .
Key words: second trimester/induced abortion/misoprostol/sublingual/vaginal
Submitted on June 6, 2008; resubmitted on July 30, 2008; accepted on August 4, 2008.
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