Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Primary Outcome Measures:

• Preterm birth prior to 37 weeks [ Time Frame: Time of birth ] [ Designated as safety issue: No ]
  Preterm birth prior to 37 weeks
  
  

Secondary Outcome Measures:

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

Other Outcome Measures:

• neonatal mortality [ Time Frame: Time of delivery ] [ Designated as safety issue: Yes ]
  neonatal mortality
  
  
• maternal and neonatal complications through 42 days postpartum, [ Time Frame: 42 days postpartum ] [ Designated as safety issue: Yes ]
  maternal and neonatal complications through 42 days postpartum,
  
  
• Incremental cost of preventing preterm birth [ Time Frame: 42 days postpartum ] [ Designated as safety issue: No ]
  Determine the costs of preventing preterm birth
  
  

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.