NEWBORN-1 Study of Retosiban vs Placebo in Women in Pre-Term Labour
Research type
Research Study
Full title
Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
IRAS ID
189680
Contact name
Andrew Shennan
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2014-003326-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 73287
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
More than 50,000 babies are born prematurely in the UK each year. Babies born prematurely are at risk of death, short term medical complications, long term disabilities and developmental problems. Spontaneous preterm labour precedes more than half of premature births.
Treatment of spontaneous preterm labour is aimed at improving outcomes for the infant. Short term tocolytic therapy is recommended for delaying birth so that corticosteroids can be given and the mother can be transferred to a special care unit. Corticosteroids reduce the risks of neonatal death and complications, but there is no evidence that current tocolytic treatments improve outcomes beyond the effect of the corticosteroids.
Retosiban is being developed for the treatment of spontaneous preterm labour. Results from a previous study show that retosiban may prolong pregnancy sufficiently to improve outcomes for the newborn.
The study’s objective is to show retosiban can improve newborn outcomes by prolonging pregnancy. Participants will be randomised to receive either retosiban or placebo as an intravenous infusion for 48 hours. Participants will receive corticosteroids and investigators are permitted to use magnesium sulphate for neuroprotection at their discretion.
After treatment, participants will be followed every week until they deliver and at 6 weeks after delivery. Infants will be followed from delivery to 28 days after a due date of 40 weeks. The following procedures will be performed: physical examination, vital signs, ECG, ultrasound, blood and urine testing, foetal monitoring, questionnaires, assessment of the infant and review of medical records. If consented, infants will be followed in a separate study until at least 5 years old.
GlaxoSmith Kline is sponsoring this study which will involve 900 patients worldwide, including 40 patients in the UK.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0533
Date of REC Opinion
13 Jan 2016
REC opinion
Further Information Favourable Opinion