Pregnancy Clinical Trial
Official title:
Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy
Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an
increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to
reduce the risk of prematurity have not found a statistically significant diminution of risk
(<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of
these findings is that some of these treatment were administered vaginally, most often
during the second or third trimester
Aim: To reduce the frequency of late abortions and very preterm birth by prescribing
clindamycin vs placebo to patients diagnosed with BV before 13 weeks.
Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be
defined as at low risk when they have no history of spontaneous preterm delivery or late
abortion. Women with such histories will be defined as at high risk.
Low risk patients will be asked to participate in a trial with 3 equal parallel groups,
comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300
mgx2/d) and placebo.
High-risk patients will be asked to participate in a trial with 2 parallel groups to assess
the usefulness of repeating antibiotic treatment monthly by comparing the administration of
one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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