Clinical Trial: A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Post-marketing, Observational, Retrospective, Cohort Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Brief Summary: The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
Detailed Summary: In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during pregnancy as part of the National immunization program in Brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the RefortrixTM (Tdap) maternal immunization program.
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Occurrence of any of the pre-specified pregnancy-related AEs in Exposed and Unexposed subjects [ Time Frame: Week 27 of pregnancy ]Gestational diabetes, Pregnancy-related hypertension (including pre-eclampsia, eclampsia and HELLP syndrome), Pregnancy haemorrhage (ante-partum (after 24 weeks of gestation), intra-partum or post-partum)
- Occurrence of pre-specified neonate-related outcomes in neonates from Exposed and Unexposed subjects [ Time Frame: For pre-term birth: Week 27 up to week 37 of pregnancy. For small for gestational age: Week 27 of pregnancy ]Preterm birth, Small for gestational age
Original Primary Outcome:
- Occurrence of any of the pre-specified pregnancy-related AEs in Exposed and Unexposed subjects [ Time Frame: After week 27 of pregnancy ]Gestational diabetes, Pregnancy-related hypertension (including pre-eclampsia, eclampsia and HELLP syndrome), Pregnancy haemorrhage (ante-partum (after 24 weeks of gestation), intra-partum or post-partum)
- Occurrence of pre-specified neonate-related outcomes in neonates from Exposed and Unexposed subjects [ Time Frame: For pre-term birth: After week 27 up to week 37 of pregnancy. For small for gestational age: After week 27 of pregnancy ]Preterm birth, Small for gestational age
Current Secondary Outcome:
- Occurrence of pregnancy-related AEs of interest/neonate-related events up to delivery in Exposed and Unexposed subjects [ Time Frame: Week 27 ]Premature rupture of membranes, Preterm premature rupture of membranes, Premature uterine contraction, Neonatal death, Maternal death, Still birth, Neonatal hypoxic ischaemic encephalopathy
- Occurrence of congenital anomalies in the neonates of Exposed and Unexposed subjects [ Time Frame: Week 27 up to birth ]
- Occurrence of pregnancy-related AEs and birth outcomes per calendar year in the Unexposed cohort [ Time Frame: Week 27 ]
Original Secondary Outcome:
- Occurrence of pregnancy-related AEs of interest/neonate-related events up to delivery in Exposed and Unexposed subjects [ Time Frame: After week 27 ]Premature rupture of membranes, Preterm premature rupture of membranes, Premature uterine contraction, Neonatal death, Maternal death, Still birth, Neonatal hypoxic ischaemic encephalopathy
- Occurrence of congenital anomalies in the neonates of Exposed and Unexposed subjects [ Time Frame: After week 27 up to birth ]
- Occurrence of pregnancy-related AEs and birth outcomes per calendar year in the Unexposed cohort [ Time Frame: After week 27 ]
Information By: GlaxoSmithKline
Dates:
Date Received: April 28, 2016
Date Started: May 6, 2016
Date Completion: May 31, 2017
Last Updated: May 16, 2017
Last Verified: May 2017