ARIOS: Follow-up of infants born to mothers in retosiban studies
Research type
Research Study
Full title
Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Studies
IRAS ID
167453
Contact name
Ruppa Geethanath
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2014-000499-24
Clinicaltrials.gov Identifier
IND number, 73287
Duration of Study in the UK
3 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.
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.
The purpose of this follow-up study is to assess safety and outcomes in infants who were exposed to retosiban or comparator in phase 3 spontaneous preterm labour treatment studies. Infants will be followed until they are at least 2 years old.
There are no study visits; parents will be asked to provide information about the health and development of their child by signing into a secure website. Parents will be alerted by text or e-mail when it is time for various questions to be completed (when the child is aged 2, 6, 9, 12, 15, 18, 21 and 24 months). The answers provided will be reviewed by study staff who may refer the child to other healthcare providers as necessary. Medical records from healthcare provider visits that occur during this time will be reviewed.
This study is sponsored by GlaxoSmithKline. Infants from 5 hospitals in the UK will be followed.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0004
Date of REC Opinion
19 Feb 2015
REC opinion
Further Information Favourable Opinion