Clinical trial NCT01800825: Clindamycin to Reduce Preterm Birth in a Low Resource Setting
Official title: Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Prematurity
Preterm Birth
Bacterial Vaginosis
Keywords: Pregnancy
Prematurity
Preterm birth
bacterial vaginosis
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Jawaharlal Nehru Medical College
name: Thrasher Research Fund
First posted: 2013-02-28
Enrollment: 1726
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Preterm birth prior to 37 weeks
timeFrame: Time of birth
Secondary outcomes:
measure: Preterm birth prior to 34 weeks
timeFrame: Time of birth
measure: Late Miscarriage
timeFrame: Time of delivery
measure: Low Birth weight
timeFrame: Time of delivery
measure: Very Low birth Weight
timeFrame: Time of delivery
measure: Neonatal complications through 42 days after delivery
timeFrame: 42 days post delivery
measure: Maternal complications through 42 days postpartum
timeFrame: 42 days post delivery
measure: The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery
timeFrame: Time of delivery
Other outcomes:
measure: neonatal mortality
timeFrame: Time of delivery
measure: maternal and neonatal complications through 42 days postpartum,
timeFrame: 42 days postpartum
measure: Incremental cost of preventing preterm birth
timeFrame: 42 days postpartum
Locations:
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
state: Karnataka
Study officials:
affiliation: Christiana Care Health Services
name: Matthew K Hoffman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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