Status:
COMPLETED
Clindamycin to Reduce Preterm Birth in a Low Resource Setting
Lead Sponsor:
Christiana Care Health Services
Collaborating Sponsors:
Jawaharlal Nehru Medical College
Thrasher Research Fund
Conditions:
Pregnancy
Prematurity
Eligibility:
FEMALE
13+ years
Phase:
PHASE4
Brief 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 t...
Detailed Description
The primary study objective is to definitively test whether 300 mg oral clindamycin two times per day for 5-days administered at 13-20 weeks of gestation in women with a vaginal pH≥5 reduces the incid...
Eligibility Criteria
Inclusion
- Women with a singleton Intrauterine pregnancy between 13-20 weeks
- Maternal age of 18 or older or if \< 18 assent of the women's parent/guardian
- Vaginal PH \> 5.0
Exclusion
- Use of antibiotics within the 14 days prior to randomization
- Known sensitivity to antibiotics
- Uterine anomalies
- Major fetal anomalies
- Medical conditions that may result in iatrogenic prematurity(e.g.diabetes, Lupus, Hypertension)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
1726 Patients enrolled
Trial Details
Trial ID
NCT01800825
Start Date
July 1 2013
End Date
April 1 2016
Last Update
July 18 2016
Active Locations (1)
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1
Jawaharlal Nehru Medical College
Belagavi, Karnataka, India