Official Title: “Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

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 such histories will be defined as at high risk.

Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.

High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• Premature delivery (16 to 32 weeks of gestation)
  • Time Frame: At delivery
    Safety Issue?: Yes

Secondary Measures

• Preterm labor, PPROM, Spontaneous preterm labor, PROM, Abruptio placentae, Chorioamnionitis, Fever > 38°C during labor, Post partum fever (> 38°), Post-partum wound infections, Perinatal death, NICU transfer, Bacterial neonatal colonisation.
  • Time Frame: At delivery
    Safety Issue?: Yes

Inclusion Criteria:

• Nugent score >= 7
• pregnant women < 15 weeks (strictly)
• signed informed consent
• >=18 old
• speaking and understanding French language

Exclusion Criteria:

• metrorrhagias during 7 days before
• birth anticipated in an other area
• clindamycin allergy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Lille

Overall Clinical Trial Officials and Contacts

Damien Subtil, PhD Principal Investigator University Hospital, Lille (France)  

Overall Contact: Damien SUBTIL, PHD 33 +3 20 44 66 26 d-subtil@chru-lille.fr

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642980

Study ID Number: University Hospital Lille (F)

ClinicalTrials.gov Identifier: NCT00642980

Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Website of the study (for patients and all kinds of public)