Clindamycin to Reduce Preterm Birth in a Low Resource Setting
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| ClinicalTrials.gov Identifier: NCT01800825 |
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Recruitment Status
:
Completed
First Posted
: February 28, 2013
Last Update Posted
: July 18, 2016
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Sponsor:
Christiana Care Health Services
Collaborators:
Jawaharlal Nehru Medical College
Thrasher Research Fund
Information provided by (Responsible Party):
Matthew Hoffman, Christiana Care Health Services
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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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pregnancy Prematurity Preterm Birth Bacterial Vaginosis | Drug: Clindamycin Drug: Placebo | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 1726 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | April 2016 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Clindamycin
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Clindamycin
Clindamycin 300mg orally twice daily for five days
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Drug: Clindamycin
Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
Other Name: Cleocin
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Placebo Comparator: placebo
This will be an identical placebot
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Drug: Placebo
This will be an identical placebo comparator made of starch.
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Primary Outcome Measures
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- Preterm birth prior to 37 weeks [ Time Frame: Time of birth ]Preterm birth prior to 37 weeks
Secondary Outcome Measures
:
- 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
Other Outcome Measures:
- 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
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800825
Locations
| India | |
| Jawaharlal Nehru Medical College | |
| Belgaum, Karnataka, India | |
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 |
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) |
| First Posted: | February 28, 2013 Key Record Dates |
| Last Update Posted: | July 18, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Matthew Hoffman, Christiana Care Health Services:
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Pregnancy Prematurity Preterm birth bacterial vaginosis |
Additional relevant MeSH terms:
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Premature Birth Vaginal Diseases Vaginosis, Bacterial Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Genital Diseases, Female Bacterial Infections Vaginitis |
Clindamycin Clindamycin palmitate Clindamycin phosphate Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |