Clindamycin to Reduce Preterm Birth in a Low Resource Setting

July 15, 2016 updated by: Matthew Hoffman, Christiana Care Health Services

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1726

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Belgaum, Karnataka, India
        • Jawaharlal Nehru Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clindamycin
Clindamycin 300mg orally twice daily for five days
Drug: Clindamycin
Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
Other Names:
  • Cleocin
Placebo Comparator: placebo
This will be an identical placebot
Drug: Placebo
This will be an identical placebo comparator made of starch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth prior to 37 weeks
Time Frame: Time of birth
Preterm birth prior to 37 weeks
Time of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth prior to 34 weeks
Time Frame: Time of birth
Preterm birth prior to 34 weeks
Time of birth
Late Miscarriage
Time Frame: Time of delivery
miscarriage between 16-20 weeks
Time of delivery
Low Birth weight
Time Frame: Time of delivery
Birth Weight< 2500 gm
Time of delivery
Very Low birth Weight
Time Frame: Time of delivery
Very Low birth Weight is birthweight <1500gm
Time of delivery
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)
42 days post delivery
Maternal complications through 42 days postpartum
Time Frame: 42 days post delivery
Maternal complications through 42 days postpartum (to assess benefit or no harm)
42 days post delivery
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
Time of delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal mortality
Time Frame: Time of delivery
neonatal mortality
Time of delivery
maternal and neonatal complications through 42 days postpartum,
Time Frame: 42 days postpartum
maternal and neonatal complications through 42 days postpartum,
42 days postpartum
Incremental cost of preventing preterm birth
Time Frame: 42 days postpartum
Determine the costs of preventing preterm birth
42 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Collaborators

Thrasher Research Fund
Jawaharlal Nehru Medical College

Investigators

  • Principal Investigator: Matthew K Hoffman, MD MPH, Christiana Care Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thrasher (DDD# 601465)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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