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

• Status: Terminated
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA

Criteria

Inclusion Criteria:

• Gestational age (GA) between 34^0/7 and 35^6/7 weeks.

• Subjects with symptoms of preterm labour.

• Subjects with a singleton pregnancy.

Exclusion Criteria:

• Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy.

• Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery.

• Use of cervical cerclage or a pessary in situ in the current pregnancy.

• The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial.