Bacterial Vaginosis, Pregnancy, Prematurity, Preterm Birth
Conditions
Keywords
Pregnancy, Prematurity, Preterm birth, bacterial vaginosis
Brief 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)
Detailed description
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.
Interventions
DRUGClindamycin
Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
DRUGPlacebo
This will be an identical placebo comparator made of starch.
Sponsors
Jawaharlal Nehru Medical College
Thrasher Research Fund
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth prior to 37 weeks | Time of birth | Preterm birth prior to 37 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Birth weight | Time of delivery | Birth Weight\< 2500 gm |
| Neonatal complications through 42 days after delivery | 42 days post delivery | Neonatal complications through 42 days after delivery (to assess benefit or no harm) |
| Maternal complications through 42 days postpartum | 42 days post delivery | 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 of delivery | The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery |
| Preterm birth prior to 34 weeks | Time of birth | Preterm birth prior to 34 weeks |
| Late Miscarriage | Time of delivery | miscarriage between 16-20 weeks |
| Very Low birth Weight | Time of delivery | Very Low birth Weight is birthweight \<1500gm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incremental cost of preventing preterm birth | 42 days postpartum | Determine the costs of preventing preterm birth |
| neonatal mortality | Time of delivery | neonatal mortality |
| maternal and neonatal complications through 42 days postpartum, | 42 days postpartum | maternal and neonatal complications through 42 days postpartum, |
Countries
India
Outcome results
None listed