Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study.

ABSTRACT:

Aim

The aim was to investigate the efficacy and safety of intravenous retosiban in women with spontaneous preterm labour.

Methods

This was a randomized, double-blind, placebo-controlled, phase 2 trial. Retosiban was administered intravenously for 48 h to women in spontaneous preterm labour between 30(0/7) and 35(6/7)  weeks' gestation with an uncomplicated singleton pregnancy in an in-patient obstetric unit. Outcome measures were uterine quiescence (primary endpoint), days to delivery, preterm delivery and safety.

Results

Uterine quiescence was achieved in 62% of women who received retosiban (n = 30) compared with 41% who received placebo (n = 34). The relative risk (RR) was 1.53 (95% credible interval [CrI] 0.98, 2.48; NS). Retosiban resulted in a significant increas

SUBMITTER: Thornton S 

PROVIDER: S-EPMC4594710 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature