ISRCTN ISRCTN14204141
DOI https://doi.org/10.1186/ISRCTN14204141
Secondary identifying numbers MEC/02/14 P02.205; NTR448
Submission date
27/02/2007
Registration date
27/02/2007
Last edited
05/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr J C M van Huisseling
Scientific

Groene Hart Hospital
P.O. Box 1098
Gouda
2800 BB
Netherlands

Phone +31 (0)18 250 5050
Email hans.van.huisseling@ghz.nl

Study information

Study designObservational, single centre, cross-sectional survey
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeScreening
Scientific titleBordetella pertussis serology in pregnancy
Study acronymKinkzwang
Study hypothesisAbout 6% of the population between three and 79 years suffers each year of a B. pertussis infection, including pregnant women. These women are a source of infection for their newborn babies.
Ethics approval(s)Approval received from the local medical ethics committee (Commissie Medische Ethiek, Leids Universitair Medisch Centrum, Leiden) (ref: P02-205).
ConditionB. pertussis infection in pregnancy
InterventionSerology for Immunoglobulin G (IgG) against pertussis toxin in blood of the mother and cord blood. The test used is the test as used by the National Institute for Public Health and the Environment (RIVM) (The Netherlands).
Intervention typeOther
Primary outcome measure1. Positive B. pertussis serology
2. Cata questionnaires
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/08/2002
Overall study end date01/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants500
Participant inclusion criteriaAll pregnant women delivering at the department of gynecology and obstetrics of the Groene Hart Hospital.
Participant exclusion criteriaDoes not comply with the above inclusion criteria
Recruitment start date01/08/2002
Recruitment end date01/06/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Groene Hart Hospital
Gouda
2800 BB
Netherlands

Sponsor information

Groene Hart Hospital (The Netherlands)
Hospital/treatment centre

Department of Gynaecology and Obstetrics
P.O. Box 1098
Gouda
2800 BB
Netherlands

Website http://www.ghz.nl/
ROR logo "ROR" https://ror.org/0582y1e41

Funders

Funder type

Government

National Institute for Public Health and the Environment (RIVM) (The Netherlands) - performing the serology

No information available

All other costs are covered by the principal investigator.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2009 05/01/2021 Yes No

Editorial Notes

05/01/2021: Publication reference added.