Oral Clindamycin during early pregnancy for prevention of preterm labor at community level
Phase 4
Completed
- Conditions
- Health Condition 1: null- Pregnant Woman with Vaginal pHâ?¥5 between 13 to 20 weeksHealth Condition 2: O600- Preterm labor without delivery
- Registration Number
- CTRI/2013/07/003799
- Lead Sponsor
- Thrasher Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1726
Inclusion Criteria
Women residing in the 12 study area clusters that present to the study PHCs/SCs for antenatal care (ANC) at 13 to 20 weeks gestation and provide cognizant written informed consent have no known sensitivity to antibiotics (clindamycin) and have singleton pregnancies are eligible for participation
Exclusion Criteria
Women using antibiotics within the prior 14 days will be excluded from study
Symptomatic women will be excluded if they have received antibiotics within the prior 14 days (including the date of the ANC visit at which the participants pH is assessed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 300 mg oral clindamycin twice daily for 5-days administered at 13-20 weeks of gestation to women with a vaginal pHâ?¥5 will reduce the incidence of preterm delivery in women receiving placebo from 17.5% by 30%, e.g., to 12.25%,Timepoint: at the time of delivery
- Secondary Outcome Measures
Name Time Method The oral clindamycin reduces the incidence of very preterm delivery (34 weeks), miscarriage, low birth weight (LBW, â?¤2,500 grams), neonatal mortality rate (NMR) and either reduces or does not significantly affect the rates of maternal and neonatal complications through 42 days postpartumTimepoint: at the time of delivery