Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Phase 2 Completed 677 enrolled Rigshospitalet, Denmark AP Moeller Foundation · collab The Danish Medical Research Council · collab The Danish Medical Society in Copenhagen · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.

Timeline

Start: 2006-06
Primary completion: 2009-02
Completion: 2010-09

Publications

Results Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.
Results Klein K, Rode L, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultrasound Obstet Gynecol. 2011 Sep;38(3):281-7. doi: 10.1002/uog.9092.
Rode L, Klein K, Larsen H, Holmskov A, Andreasen KR, Uldbjerg N, Ramb J, Bodker B, Skibsted L, Sperling L, Hinterberger S, Krebs L, Zingenberg H, Weiss EC, Strobl I, Laursen L, Christensen JT, Skogstrand K, Hougaard DM, Krampl-Bettelheim E, Rosthoj S, Vogel I, Tabor A. Cytokines and the risk of preterm delivery in twin pregnancies. Obstet Gynecol. 2012 Jul;120(1):60-8. doi: 10.1097/AOG.0b013e31825bc3cd.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Progesterone	Other / unclassified	200 mg	Intravenous

Indications

No indication recorded.