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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Prematurity Preterm Birth Bacterial Vaginosis | Drug: Clindamycin Drug: Placebo | Phase 4 |
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 |

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 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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- Preterm birth prior to 37 weeks [ Time Frame: Time of birth ]Preterm birth prior to 37 weeks
- 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
- 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 |
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)

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
India | |
Jawaharlal Nehru Medical College | |
Belgaum, Karnataka, India |
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:
Pregnancy Prematurity Preterm birth bacterial vaginosis |
Additional relevant MeSH terms:
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 |