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A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth — TERM  

Preterm Labor Clinical Trial

Official title:
A Phase 2, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Safety and Efficacy of OBE001 After Oral Administration in Pregnant Women With Threatened Preterm Labour.

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.

Clinical Trial Description

The study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34^0/7 and 35^6/7 weeks of gestation.

The study will be in 2 parts as follows:

- from screening until the day of delivery (including a treatment period up to seven days)

- a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later).

In addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02326142
Study type Interventional
Source ObsEva SA
Contact
Status Terminated
Phase Phase 2
Start date March 2015
Completion date October 2017
View Details
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