Pregnancy | Clindamycin to Reduce Preterm Birth in a Low Resource Setting
Pregnancy research study
What is the primary objective of this study?
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)
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ClindamycinClindamycin 300 mg Orally will be administered twice daily for a total of 5 days
Drug:PlaceboThis will be an identical placebo comparator made of starch.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ClindamycinClindamycin 300mg orally twice daily for five days
placeboThis will be an identical placebot
Start Date: July 2013
Completed Date: April 2016
Phase: Phase 4
Primary Outcome: Preterm birth prior to 37 weeks
Secondary Outcome: Preterm birth prior to 34 weeks
Study sponsors, principal investigator, and references
Principal Investigator: Matthew K Hoffman, MD MPH
Lead Sponsor: Christiana Care Health Services
Collaborator: Jawaharlal Nehru Medical College
Lamont RF, Nhan-Chang CL, Sobel JD, Workowski K, Conde-Agudelo A, Romero R. Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysis. Am J Obstet Gynecol. 2011 Sep;205(3):177-90. doi: 10.1016/j.ajog.2011.03.047. Epub 2011 Apr 2. Review.