Status:
COMPLETED
Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Pfizer
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with s...
Eligibility Criteria
Inclusion
- Nugent score \>= 7
- pregnant women \< 15 weeks (strictly)
- signed informed consent
- \>=18 old
- speaking and understanding French language
Exclusion
- metrorrhagias during 7 days before
- birth anticipated in an other area
- clindamycin allergy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
3105 Patients enrolled
Trial Details
Trial ID
NCT00642980
Start Date
April 1 2006
End Date
June 1 2011
Last Update
October 1 2025
Active Locations (1)
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1
Hopital Jeanne de Flandre
Lille, France, 59 000