The purpose of this study is to monitor the safety of the medications used in the preterm labor study by collecting information on the health and development of the child after child’s mother participated in a retosiban study for preterm labor during the child’s mother’s pregnancy.
- Conditions
- preterm labour and improve neonatal healthMedDRA version: 19.0 Level: PT Classification code 10036595 Term: Premature delivery System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2014-000499-24-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 330
Infants eligible for enrollment in the study must meet all of the following criteria:
1.Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III retosiban clinical studies.
2.Infant is alive at 28 days post EDD.
3.Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of participants aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
All infants who meet the inclusion criteria will be eligible to enroll in the study. There are no formal exclusion criteria for participation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method