Bordetella pertussis serology in pregnancy
| ISRCTN | ISRCTN14204141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14204141 |
| Protocol serial number | MEC/02/14 P02.205; NTR448 |
| Sponsor | Groene Hart Hospital (The Netherlands) |
| Funders | National Institute for Public Health and the Environment (RIVM) (The Netherlands) - performing the serology, All other costs are covered by the principal investigator. |
- 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 of protocol
Not provided at time of registration
Contact information
Dr J C M van Huisseling
Scientific
Scientific
Groene Hart Hospital
P.O. Box 1098
Gouda
2800 BB
Netherlands
| Phone | +31 (0)18 250 5050 |
|---|---|
| hans.van.huisseling@ghz.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational, single centre, cross-sectional survey |
| Secondary study design | Cross sectional study |
| Scientific title | Bordetella pertussis serology in pregnancy |
| Study acronym | Kinkzwang |
| Study objectives | 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(s) | Approval received from the local medical ethics committee (Commissie Medische Ethiek, Leids Universitair Medisch Centrum, Leiden) (ref: P02-205). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Positive B. pertussis serology |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 500 |
| Key inclusion criteria | All pregnant women delivering at the department of gynecology and obstetrics of the Groene Hart Hospital. |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Groene Hart Hospital
Gouda
2800 BB
Netherlands
2800 BB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
