This study focuses on pregnant women who are at a high risk of preterm birth, which is a birth that occurs before 37 weeks of pregnancy. The research looks at individuals with vaginal flora abnormalities, meaning an imbalance in the natural bacteria found in the vagina, and Bacterial vaginosis, a common condition caused by an overgrowth of certain bacteria. The purpose of the study is to evaluate if using a new testing method to identify these imbalances early in pregnancy can help reduce the number of early births.
Participants may receive different treatments depending on their assigned group. Medications used in the study include clotrimazole, metronidazole, azithromycin, ceftriaxone, and doxycycline. Some treatments are taken by mouth as a tablet, while others are administered through an intramuscular injection, which is a shot given into a muscle, or as a vaginal capsule, which is a soft medication inserted into the vagina. Some participants may also receive a placebo instead of the active medication.
During the study, women will undergo screening to check for bacterial imbalances using molecular biology, a method used to look at the genetic material of bacteria to identify them. The course of the study involves monitoring the health of both the mother and the baby throughout the pregnancy and following the outcomes of the birth. This includes tracking various health factors such as the length of the pregnancy and any medical needs for the newborn.
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