A Phase 4 interventional study of Clindamycin and Placebo in Pregnancy, Prematurity and Preterm Birth, sponsored by Christiana Care Health Services. Completed at 1 site in India. Open to female participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2016-07-18.
Sponsored by Christiana Care Health Services · Phase 4, Interventional, and Prevention
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)
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 1,726 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Clindamycin 300mg orally twice daily for five days
Drug: Clindamycin
This will be an identical placebot
Drug: Placebo
Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
Also known as: Cleocin
This will be an identical placebo comparator made of starch.
Preterm birth prior to 37 weeks
Preterm birth prior to 37 weeks
Time frame: Time of birth
Preterm birth prior to 34 weeks
Preterm birth prior to 34 weeks
Time frame: Time of birth
Late Miscarriage
miscarriage between 16-20 weeks
Time frame: Time of delivery
Low Birth weight
Birth Weight\< 2500 gm
Time frame: Time of delivery
Very Low birth Weight
Very Low birth Weight is birthweight \<1500gm
Time frame: Time of delivery
Neonatal complications through 42 days after delivery
Neonatal complications through 42 days after delivery (to assess benefit or no harm)
Time frame: 42 days post delivery
Maternal complications through 42 days postpartum
Maternal complications through 42 days postpartum (to assess benefit or no harm)
Time frame: 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 frame: Time of delivery
neonatal mortality
neonatal mortality
Time frame: Time of delivery
maternal and neonatal complications through 42 days postpartum,
maternal and neonatal complications through 42 days postpartum,
Time frame: 42 days postpartum
Incremental cost of preventing preterm birth
Determine the costs of preventing preterm birth
Time frame: 42 days postpartum
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Christiana Care Health Services