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Journal of Perinatal Medicine

Official Journal of the World Association of Perinatal Medicine

Editor-in-Chief: Dudenhausen, Joachim W.

Editorial Board Member: / Bancalari, Eduardo / Greenough, Anne / Genc, Mehmet R. / Chervenak, Frank A. / Chappelle, Joseph / Bergmann, Renate L. / Bernardes, J.F. / Bevilacqua, G. / Blickstein, Isaac / Cabero Roura, Luis / Carbonell-Estrany, Xavier / Carrera, Jose M. / D`Addario, Vincenzo / D'Alton, MD, Mary E. / Dimitrou, G. / Grunebaum, Amos / Hentschel, Roland / Köpcke, W. / Kawabata, Ichiro / Keirse, Marc J.N.C. / Kurjak M.D., Asim / Lee, Ben H. / Levene, Malcolm / Lockwood, Charles J. / Marsal, Karel / Makatsariya, Alexander / Nishida, Hiroshi / Ogata, Edward / Papp, Zoltán / Pejaver, Ranjan Kumar / Pooh, Ritsuko K. / Romero, Roberto / Saugstad, Ola D. / Schenker, Joseph G. / Sen, Cihat / Seri, Istvan / Vetter, Klaus / Winn, Hung N. / Young, Bruce K. / Zimmermann, Roland


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1619-3997
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Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial

1, 2 / Sue Ross1–3, , / Selphee Tang1 / Leslie Miller1 / Reg Sauve2, 4 / Rollin Brant2, 5, 6

1Department of Obstetrics and Gynecology, University of Calgary, Calgary, AB, Canada

2Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada

3Departments of Family Medicine, University of Calgary, Calgary, AB, Canada

4Department of Pediatrics (Neonatology), University of Calgary, Calgary, AB, Canada

5Centre for Community Child Health Research, BC Research Institute for Children’s and Women’s Health, Vancouver, BC, Canada

6Department of Statistics, University of British Columbia, Vancouver, BC, Canada

Corresponding author: Stephen Wood Department of Obstetrics and Gynaecology University of Calgary, Foothills Medical Centre 4th Floor, North Tower, 1441 – 29th Street NW, Calgary, AB Canada T2N 4J8 Tel.: +1-403-944-8458 Fax: +1-403-270-4249

Citation Information: . Volume 40, Issue 6, Pages 593–599, ISSN (Online) 1619-3997, ISSN (Print) 0300-5577, DOI: 10.1515/jpm-2012-0057, July 2012

Publication History

Received:
2012-03-25
Accepted:
2012-06-18
Published Online:
2012-07-14

Abstract

Aim: We sought to assess the effect of progesterone in increasing or decreasing duration of pregnancy for mothers with twins and triplets.

Methods: Women with multiple pregnancy were randomized at 16+0 to 20+6 weeks’ gestation to receive daily doses of either 90 mg progesterone vaginal gel or placebo until 35+6 weeks or delivery. Primary outcome was gestational age (GA) at delivery. Secondary outcomes included preterm birth, infant morbidity and mortality, and adverse events up to 28 days after delivery. A sample size of 40 per group was required to detect a 2-week difference in GA at delivery.

Results: Eighty-four women were randomized (42 to progesterone, 42 to placebo). Median GA at delivery was 36+3 and 36+2, respectively (difference, 1 day; 95% confidence interval, 4 to –1 days, P=0.585). There were no clinically or statistically significant differences between groups for risk of delivery before 35 or 37 weeks’ GA, rates of infant morbidity and mortality, treatment compliance, or adverse events.

Conclusions: Daily treatment with progesterone gel did not prolong multiple pregnancy compared with placebo. Effective prevention strategies are needed to reduce preterm deliveries among women with multiple gestations.

Keywords: Controlled clinical trial; multiple; pregnancy; preterm birth; progesterone

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