Trial record 15 of 39 for:    Open Studies | "Vaginitis"

Clindamycin to Reduce Preterm Birth in a Low Resource Setting

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Christiana Care Health Services
Sponsor:
Collaborators:
Jawaharlal Nehru Medical College
Thrasher Research Fund
Information provided by (Responsible Party):
Matthew Hoffman, Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01800825
First received: February 20, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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)


Condition Intervention Phase
Pregnancy
Prematurity
Preterm Birth
Bacterial Vaginosis
Drug: Clindamycin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Preterm birth prior to 37 weeks [ Time Frame: Time of birth ] [ Designated as safety issue: No ]
    Preterm birth prior to 37 weeks


Secondary Outcome Measures:
  • Preterm birth prior to 34 weeks [ Time Frame: Time of birth ] [ Designated as safety issue: No ]
    Preterm birth prior to 34 weeks

  • Late Miscarriage [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
    miscarriage between 16-20 weeks

  • Low Birth weight [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
    Birth Weight< 2500 gm

  • Very Low birth Weight [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
    Very Low birth Weight is birthweight <1500gm

  • Neonatal complications through 42 days after delivery [ Time Frame: 42 days post delivery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery


Other Outcome Measures:
  • neonatal mortality [ Time Frame: Time of delivery ] [ Designated as safety issue: Yes ]
    neonatal mortality

  • maternal and neonatal complications through 42 days postpartum, [ Time Frame: 42 days postpartum ] [ Designated as safety issue: Yes ]
    maternal and neonatal complications through 42 days postpartum,

  • Incremental cost of preventing preterm birth [ Time Frame: 42 days postpartum ] [ Designated as safety issue: No ]
    Determine the costs of preventing preterm birth


Estimated Enrollment: 1726
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cleocin
Placebo Comparator: placebo
This will be an identical placebot
Drug: Placebo
This will be an identical placebo comparator made of starch.
Other Name: Placebo

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800825

Contacts
Contact: Mrutyunjaya Bellad, MD mbbellad@hotmail.com
Contact: Shivaprasad Goudar, MD sgoudar@jnmc.edu

Locations
India
Jawaharlal Nehru Medical College Recruiting
Belgaum, Karnataka, India
Contact: Shivaprasad S Goudar, MD       sgoudar@jnmc.edu   
Contact: Mrutyunjaya B Bellad, MD       Mbellad@hotmail.com   
Principal Investigator: Mrutyunjaya B Bellad, MD         
Sponsors and Collaborators
Christiana Care Health Services
Jawaharlal Nehru Medical College
Thrasher Research Fund
Investigators
Principal Investigator: Matthew K Hoffman, MD MPH Christiana Care Health Services
  More Information

Additional Information:
Publications:

Responsible Party: Matthew Hoffman, Vice Chair of Department of Obstetrics and Gynecology, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01800825     History of Changes
Other Study ID Numbers: Thrasher (DDD# 601465)
Study First Received: February 20, 2013
Last Updated: January 17, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Christiana Care Health Services:
Pregnancy
Prematurity
Preterm birth
bacterial vaginosis

Additional relevant MeSH terms:
Vaginitis
Vaginosis, Bacterial
Premature Birth
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Clindamycin
Clindamycin-2-phosphate
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014