Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose-ranging study.

ABSTRACT:

Aims

The aims of the present study were to investigate the maternal, fetal and neonatal safety and tolerability, pharmacodynamics and pharmacokinetics of intravenous (IV) retosiban in pregnant women with spontaneous preterm labour (PTL) between 34^0/7 and 35^6/7  weeks' gestation.

Methods

In parts A and B of a three-part, double-blind, placebo-controlled, multicentre study, women were randomized 3:1 (Part A) or 2:1 (Part B) to either 12-h IV retosiban followed by a single dose of oral placebo (R-P) or 12-h IV placebo followed by single-dose oral retosiban (P-R).

Results

A total of 29 women were randomized; 20 to R-P and nine to P-R. An integrated analysis found that adverse events were infrequent in mothers/newborns and consistent with events expec

SUBMITTER: Thornton S 

PROVIDER: S-EPMC5595955 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature