Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
25/05/2016
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 GCL Lachelin

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Royal Free and University College Medical School
86-96 Chenies Mews
London
WC1E 6HX
United Kingdom
+44 (0)20 7209 6054
gillian.lachelin@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263022099

Study information

Scientific title

Randomised double blind placebo controlled trial of antimicrobial treatment in pregnant women at risk of preterm labour

Acronym

Study hypothesis

Does treatment of fetal fibronectin positive pregnant women with an antimicrobial drug reduce the incidence of preterm labour and delivery?

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Pregnancy and Childbirth: Preterm labour

Intervention

Randomised controlled trial:
A. Antibiotic
B. Placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Preterm labour and delivery. Delivery after 37 weeks gestation.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1997

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

75 Patients from Obstetrics/Midwifery.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

75

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/07/1997

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics and Gynaecology
London
WC1E 6HX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

University College London Hospitals NHS Trust (UK)

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

25/05/2016: No publications found, verifying study status with principal investigator