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Screening for Bacterial Vaginosis to Prevent Premature Birth (SECRETIVA Trial)

N/A

Recruiting

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Age greater than or equal to 18 years old

Must not have

Desires termination during this pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)

Awards & highlights

No Placebo-Only Group

Summary

This trialwill determine if bacterial vaginosis increases the risk of preterm delivery in women with a history of preterm births. Subjects will be randomly tested or not.

Who is the study for?

This trial is for pregnant women over 18, less than 32 weeks along, with a history of early delivery or short cervix. They must get care at Loma Linda and follow the study plan. It's not for those with certain conditions like severe preeclampsia or who aren't at high risk for early birth.

What is being tested?

The study tests if extra vaginal swabs to screen for bacterial vaginosis can prevent preterm births in women with a history of it. Participants are randomly placed into two groups: one gets regular testing and treatment; the other follows standard prenatal care.

What are the potential side effects?

There may be minimal side effects from additional vaginal swabs such as discomfort during the procedure. However, specific side effects will depend on any treatments used if bacterial vaginosis is detected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I want to end my current pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)

This trial's timeline: 3 weeks for screening, Varies for treatment, and number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Length of hospital stay of mothers

Length of hospital stay of neonates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Intervention ArmActive Control1 Intervention

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.

Group II: Control ArmActive Control1 Intervention

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.

0 / 3Eligibility criteria met