Condition category
Pregnancy and Childbirth
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
14/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J C M van Huisseling

ORCID ID

Contact details

Groene Hart Hospital
P.O. Box 1098
Gouda
2800 BB
Netherlands
+31 (0)18 250 5050
hans.van.huisseling@ghz.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC/02/14 P02.205; NTR448

Study information

Scientific title

Acronym

Kinkzwang

Study hypothesis

About 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

Approval received from the local medical ethics committee (Commissie Medische Ethiek, Leids Universitair Medisch Centrum, Leiden) (ref: P02-205).

Study design

Observational, single centre, cross-sectional survey

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

B. pertussis infection in pregnancy

Intervention

Serology 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Positive B. pertussis serology
2. Cata questionnaires

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2002

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women delivering at the department of gynecology and obstetrics of the Groene Hart Hospital.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/08/2002

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Groene Hart Hospital
Gouda
2800 BB
Netherlands

Sponsor information

Organisation

Groene Hart Hospital (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.ghz.nl/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

All other costs are covered by the principal investigator.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes