Clindamycin to Reduce Preterm Birth in a Low Resource Setting

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christiana Care Health Services
• Collaborators: Jawaharlal Nehru Medical College; Thrasher Research Fund
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)