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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Clindamycin
* Drug: Placebo
* Drug: Clindamycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clindamycin Cure 1<br>Arm 1 | Drug: Clindamycin<br>* 300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart<br>* Other names: non applicable;|
| Active Comparator: Clindamycin Cure 2<br>Arm 2 | Drug: Clindamycin<br>* 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<br>* Other names: non applicable;|
| Placebo Comparator: Placebo<br>Arm placebo | Drug: Placebo<br>* Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart<br>* Other names: non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature delivery (16 to 32 weeks of gestation) |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Preterm delivery, Bacterial vaginosis, Randomized Clinical Trial, Clindamycin