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Clindamycin to Reduce Preterm Birth in a Low Resource Setting

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ClinicalTrials.gov Identifier: NCT01800825
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : July 18, 2016
Sponsor:
Collaborators:
Jawaharlal Nehru Medical College
Thrasher Research Fund
Information provided by (Responsible Party):
Matthew Hoffman, Christiana Care Health Services

February 20, 2013
February 28, 2013
July 18, 2016
July 2013
April 2016   (Final data collection date for primary outcome measure)
Preterm birth prior to 37 weeks [ Time Frame: Time of birth ]
Preterm birth prior to 37 weeks
Same as current
Complete list of historical versions of study NCT01800825 on ClinicalTrials.gov Archive Site
  • Preterm birth prior to 34 weeks [ Time Frame: Time of birth ]
    Preterm birth prior to 34 weeks
  • Late Miscarriage [ Time Frame: Time of delivery ]
    miscarriage between 16-20 weeks
  • Low Birth weight [ Time Frame: Time of delivery ]
    Birth Weight< 2500 gm
  • Very Low birth Weight [ Time Frame: Time of delivery ]
    Very Low birth Weight is birthweight <1500gm
  • Neonatal complications through 42 days after delivery [ Time Frame: 42 days post delivery ]
    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 ]
    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 ]
    The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery
Same as current
  • neonatal mortality [ Time Frame: Time of delivery ]
    neonatal mortality
  • maternal and neonatal complications through 42 days postpartum, [ Time Frame: 42 days postpartum ]
    maternal and neonatal complications through 42 days postpartum,
  • Incremental cost of preventing preterm birth [ Time Frame: 42 days postpartum ]
    Determine the costs of preventing preterm birth
Same as current
 
Clindamycin to Reduce Preterm Birth in a Low Resource Setting
Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pregnancy
  • Prematurity
  • Preterm Birth
  • Bacterial Vaginosis
  • Drug: Clindamycin
    Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
    Other Name: Cleocin
  • Drug: Placebo
    This will be an identical placebo comparator made of starch.
  • Active Comparator: Clindamycin
    Clindamycin 300mg orally twice daily for five days
    Intervention: Drug: Clindamycin
  • Placebo Comparator: placebo
    This will be an identical placebot
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1726
Same as current
April 2016
April 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
13 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01800825
Thrasher (DDD# 601465)
Yes
Not Provided
Not Provided
Matthew Hoffman, Christiana Care Health Services
Christiana Care Health Services
  • Jawaharlal Nehru Medical College
  • Thrasher Research Fund
Principal Investigator: Matthew K Hoffman, MD MPH Christiana Care Health Services
Christiana Care Health Services
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP