Pertussis in Pregnancy Safety (PIPS) Study - Evaluating health outcomes in infants of mothers vaccinated with the tetanus, diphtheria, and pertussis (Tdap) vaccine during pregnancy and to describe the adverse events in pregnant women who received the Tdap vaccine

Not Applicable

• Conditions: health outcomes in infants of mothers vaccinated with Tdap during pregnancy; adverse events in pregnant women who received Tdap vaccine; Public Health - Epidemiology

• Registration Number: ACTRN12613001045707
• Lead Sponsor: niservices

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Study one-NZ women who are pregnant during the study period 2009-2013.
Study two- Pregnant women who have received the Tdap vaccine during pregnancy between 28 and 38 weeks of gestation. Compliant with routine antenatal care, including at least one ultrasound early in pregnancy. Have associated information on the specific vaccines given, including batch number

Exclusion Criteria

Study 1 no exclusion
Study 2 If a woman has already had her baby prior to being contacted by the study team she will not be enrolled in the study

Study & Design

• Study Type: Observational
• Study Design: Not specified