At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,726 enrolled
Drug / intervention
Clindamycin +1 moredrug
Likely dose
Clindamycin 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial
In Brief
A Phase 4 clinical trial evaluating Clindamycin and Placebo for Pregnancy and 3 related conditions. Completed, enrolled 1,726 participants across 1 site.
Detailed Summary
Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Prematurity, Preterm Birth, Bacterial Vaginosis
CountriesIndia
CollaboratorsJawaharlal Nehru Medical College, Thrasher Research Fund
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartJul 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedFeb 28, 2013
Enrollment StartJul 1, 2013
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.3 years ago
Interventions
Clindamycindrug
Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
Placebodrug
This will be an identical placebo comparator made of starch.