ZINN: Retosiban versus atosiban for spontaneous pre-term labour
Research type
Research Study
Full title
Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
IRAS ID
167451
Contact name
Dilly OC Anumba
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2014-001826-13
Clinicaltrials.gov Identifier
IND number, 73287
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
More than 50,000 babies are born prematurely (before 37 weeks’ gestation) 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.
As the risks for complications are greater the earlier the baby is born, retosiban is being developed to prolong pregnancy in mothers experiencing spontaneous preterm labour. Results from a previous study show that retosiban may prolong pregnancy sufficiently to improve outcomes for the neonate.
The purpose of this study is to demonstrate that retosiban is more effective at prolonging pregnancy than atosiban, a currently approved tocolytic therapy. Participants will be randomised to receive either retosiban or atosiban in a 1:1 ratio. Study drug will be given as an intravenous infusion over 48 hours.
After treatment, participants will be followed every week until they deliver and 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 during the study: physical examination, vital signs, ECG, ultrasound, blood and urine testing, foetal monitoring, questionnaires, assessment of the infant and review of medical records. If consent is given, infants will be followed in a separate study until they are at least 2 years old.
This study is sponsored by GlaxoSmithKline. Approximately 330 patients will participate in this study worldwide with 30 patients from 5 hospitals in the UK.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0003
Date of REC Opinion
23 Feb 2015
REC opinion
Further Information Favourable Opinion