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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613001045707

Acronym

Pertussis in Pregnancy Safety (PIPS) Study

Enrollment

300

Registered

2013-09-19

Start date

2013-10-21

Completion date

2014-01-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The rates and patterns of adverse events following administration of Tdap during pregnancy (including the rates and patterns of any adverse pregnancy outcome, and the outcomes in infants up to one year of age), are similar to those where no vaccination during pregnancy occurred

Interventions

This is a two-component observational study that will collect data both retrospectively and prospectively. Data for all pregnant women and their infants in NZ between 2009 and 2013 will be obtained and pertussis vaccine exposure during pregnancy verified (Study One). A sub-study will actively follow mothers who received Tdap during pregnancy with one also following their infants for upto one year after birth (Study Two ).

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

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

Outcome results