Premature Birth Clinical Trial
Official title:
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.
This is an open-label, comparative, and prospective study. Pregnant women, pregnancy week 26
to 36+6, between the ages 18-45, who were hospitalized in the high risk department, with
history of previous preterm delivery and/or with premature contractions. Patient with
premature ruptured membrane will be excluded.
In the hospital pregnant women with history of previous preterm delivery or with premature
contractions, (participants) will be examined by speculum with no lubricant, The clinician
will use the VS-SENSE to sample vaginal secretions and will immediately observe and record
the color obtained.Should the VS-SENSE produce positive results the physician will consider
giving clindamycin treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
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