The purpose of this study is to monitor the safety of the medications usedin the preterm labor study by collecting information on the health anddevelopment of the child after child's mother participated in a retosibanstudy for preterm labor during the child's mother's pregnancy

• Conditions: Preterm labour and improve neonatal health; MedDRA version: 18.0Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-000499-24-IT
• Lead Sponsor: GLAXOSMITHKLINE S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-14
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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.
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

Exclusion Criteria

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