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Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis

NCT00642980 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3105

Last updated 2025-10-01

No results posted yet for this study

Summary

Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (\<= 32 wks: OR=0.49 \[0.05-5.1\], \< 37 wks: OR=0.83 \[0.59-1.17\]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester

Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.

Conditions

  • Pregnancy

Interventions

DRUG

Clindamycin

300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart

DRUG

Placebo

Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart

DRUG

Clindamycin

300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Damien SUBTIL, MD PhD · University Hospital, Lille (France)

  • Gilles Brabant, MD · Groupe Hospitalier de l' Institut Catholique, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642980 on ClinicalTrials.gov