Preterm Delivery Clinical Trial
Official title:
Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
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.
Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases
of preterm delivery. Due to increasing maternal age and use of assisted reproduction the
number of multiple gestations is larger than ever. If markers of preterm delivery can be
identified and means of preventing preterm delivery are found, it will be possible to reduce
the number of children admitted to hospital because of prematurity.
Recently, two larger randomised studies investigated the effect of progesterone in singleton
pregnancies of women who had previously delivered preterm. They both found a significant
reduction in the preterm delivery rate in the progesterone group compared to a placebo
group.
The study will be performed as a randomized, double-blind placebo controlled study of twin
pregnancies in Denmark and Austria. The women will be randomised in a 1:1 ratio to two
groups (progesterone versus placebo). Randomisation will be stratified per centre and
according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins
compared to dichorionic twins.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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