Randomised double blind placebo controlled trial of antimicrobial treatment in pregnant women at risk of preterm labour
| ISRCTN | ISRCTN43735180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43735180 |
| Protocol serial number | N0263022099 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 25/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr GCL Lachelin
Scientific
Scientific
Department of Obstetrics and Gynaecology
Royal Free and University College Medical School
86-96 Chenies Mews
London
WC1E 6HX
United Kingdom
| Phone | +44 (0)20 7209 6054 |
|---|---|
| gillian.lachelin@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised double blind placebo controlled trial of antimicrobial treatment in pregnant women at risk of preterm labour |
| Study objectives | Does treatment of fetal fibronectin positive pregnant women with an antimicrobial drug reduce the incidence of preterm labour and delivery? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Preterm labour |
| Intervention | Randomised controlled trial: A. Antibiotic B. Placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Preterm labour and delivery. Delivery after 37 weeks gestation. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 75 |
| Key inclusion criteria | 75 Patients from Obstetrics/Midwifery. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/07/1997 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Obstetrics and Gynaecology
London
WC1E 6HX
United Kingdom
WC1E 6HX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/05/2016: No publications found, verifying study status with principal investigator
