Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Study Overview
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Brief Summary
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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)

Detailed Description
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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 incidence of preterm delivery in Karnataka, India by at least 30%. The national incidence of gestation <37 weeks in India is 14.5%, was 18% in the study area in 2011 and was 20% among women with vaginal pH≥5 in the recently completed Jawaharlal Nehru Medical Collage (JNMC) hospital-based study of clindamycin to reduce preterm birth. Using a two tailed test, α=0.05, 1-β=80%, a 17.5% rate of prematurity in women with vaginal pH≥5, a 2.5% refusal and a 7.5% loss to follow-up, assuming 86% of women presenting for antenatal care are 13-20 weeks gestation and 1% otherwise ineligible, and a multiple comparisons adjustment, 1,726 women, half in the clindamycin and half in the placebo group, need to be enrolled to test the primary hypothesis. The effects of clindamycin on spontaneous preterm birth, miscarriage, low birthweight (LBW), neonatal mortality (NMR), maternal and neonatal complications through 42 days postpartum, the utility of vaginal pH≥5 to identify women at risk for preterm delivery and the costs of preterm birth prevented by oral clindamycin treatment and compliance with the 5-day treatment regimen will also be assessed. This will be the first investigation to test whether oral clindamycin prevents preterm birth in a community-based, developing country setting, where most global newborn deaths occur.

Official Title
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Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial

Conditions
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Pregnancy, Prematurity, Preterm Birth, Bacterial Vaginosis

Intervention / Treatment
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* Drug: Clindamycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clindamycin<br>Clindamycin 300mg orally twice daily for five days | Drug: Clindamycin<br>* Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days<br>* Other names: Cleocin;|
| Placebo Comparator: placebo<br>This will be an identical placebot | Drug: Placebo<br>* This will be an identical placebo comparator made of starch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth prior to 37 weeks | Preterm birth prior to 37 weeks | Time of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth prior to 34 weeks | Preterm birth prior to 34 weeks | Time of birth | 
| Late Miscarriage | miscarriage between 16-20 weeks | Time of delivery | 
| Low Birth weight | Birth Weight< 2500 gm | Time of delivery | 
| Very Low birth Weight | Very Low birth Weight is birthweight <1500gm | Time of delivery | 
| Neonatal complications through 42 days after delivery | Neonatal complications through 42 days after delivery (to assess benefit or no harm) | 42 days post delivery | 
| Maternal complications through 42 days postpartum | Maternal complications through 42 days postpartum (to assess benefit or no harm) | 42 days post delivery | 
| The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery | The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery | Time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Preterm birth, bacterial vaginosis, Prematurity