Serial Screening and Treatment of Bacterial Vaginosis Trial (SECRETIVA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Delivery; Bacterial Vaginosis
• Intervention / Treatment: Other: Additional vaginal swabs

Detailed Description

Preterm delivery affects 10% of all pregnancies in the United States. This risk is further increased in pregnant women with a history of preterm delivery. There are multiple etiology contributing of preterm labor. Of these, the presence of inflammation and infection have been a well-established cause. Bacterial vaginosis (BV), a common vaginal infection in pregnancy, may often be asymptomatic. Studies demonstrate a strong association between BV and preterm labor. Therefore it is recommended that women at high risk for preterm delivery are treated for this infection irregardless of symptoms. In this study the investigators hypothesize that increased testing for bacterial vaginosis, with subsequent timely treatment, may decrease the risk of preterm delivery in patients who are at high risk. The investigators suspect that the increase in monitoring will help diagnose asymptomatic bacterial vaginosis infections allowing for prompt treatment and avoidance of preterm labor.

Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control. No experimental drugs or devices will be used.

• The intervention-arm will have a pelvic exam performed with vaginal swab collection at their initial obstetric visit. The women undergoing the intervention will then subsequently undergo additional vaginal swab collections in 2 week intervals starting at 16 weeks gestational age until 34 weeks gestational age.
• The control arm will undergo the standard of care. There will be no placebo for the control group.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikia Gray-Hutto, RN, CCRP; Phone Number: 44428 9095584000; Email: nhutto@llu.edu
• Study Contact Backup: Name: Ashra Denise Tugung, BSc; Phone Number: 15580 9095584000; Email: atugung@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Children'S Hospital
      • Contact: Ashra Tugung, BSc; Phone Number: 909-651-5580; Email: atugung@llu.edu
      • Principal Investigator: Ruofan Yao, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Arm; The intervention-arm will have a pelvic exam performed with vaginal swab collection at their initial obstetric visit (standard of care). The women undergoing the intervention will then subsequently undergo additional vaginal swab collections in 2 week intervals starting at 16 weeks gestational age until 34 weeks gestational age. Subjects will be informed of the results of the vaginal swab. If positive for an infection, subjects will be provided with the appropriate treatment in pregnancy.	Other: Additional vaginal swabs; Every 2 weeks from 16 weeks gestational age to 34 weeks gestational age
No Intervention: Control Arm; The control arm will undergo the standard of care with vaginal swab collection at their initial obstetric visit. The control arm will not undergo additional vaginal swab collections unless otherwise indicated under standard of care (further testing for bacterial vaginosis is completed in women who describe symptoms with the diagnosis or present for preterm contractions and/or pelvic cramping). There will be no placebo for the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with premature delivery (before 37 weeks gestation)	At delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay of mothers	The length of hospital stay for mothers will be measured in hours from the time of admission to labor and delivery unit to the time of discharge from the post-partum unit.	Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission
Length of hospital stay of neonates	The length of hospital stay for neonates will be measured in hours from the time of admission (birth) to discharge from the postpartum unit or neonatal intensive care unit	Number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bacterial Vaginosis; Vaginoses, Bacterial
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Premature Birth; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: 5220115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No