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Clindamycin to Reduce Preterm Birth in a Low Resource Setting

NCT01800825 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1726

Last updated 2016-07-18

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Clindamycin

Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days

DRUG

Placebo

This will be an identical placebo comparator made of starch.

Sponsors & Collaborators

  • Jawaharlal Nehru Medical College

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Matthew K Hoffman, MD MPH · Christiana Care Health Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01800825 on ClinicalTrials.gov