Serial Screening and Treatment of Bacterial Vaginosis Trial

Description

The purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.

Conditions

Bacterial Vaginosis, Preterm Delivery

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Study Overview

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Study Details

Study overview

The purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.

Serial Screening and Treatment of Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: A Randomized Control Trial

Serial Screening and Treatment of Bacterial Vaginosis Trial

Condition
Bacterial Vaginosis
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University Children's Hospital, Loma Linda, California, United States, 92354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female
  • * Age greater than or equal to 18 years old
  • * Pregnancy at less than 32 weeks gestational age at initial obstetric visit with Loma Linda Maternal Fetal Medicine (MFM) Clinic
  • * History of at least one prior preterm delivery \>16 and \<37 weeks not due to iatrogenic indications, or short cervical length \<2.5cm
  • * Willing to receive prenatal standard of care and comply with treatment plan and other study procedures at Loma Linda
  • * Patients not deemed to be high risk for preterm delivery
  • * Patient with cervical dilation ≥1cm on initial exam or with protruding membranes
  • * Current pregnancy is multigestation
  • * Medical indications for iatrogenic preterm delivery during this pregnancy (e.g. preeclampsia with severe features)
  • * Desires termination during this pregnancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Loma Linda University,

Study Record Dates

2027-12