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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

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

SECRETIVA Trial 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.Check my eligibility

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.See study design

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.

SECRETIVA Trial 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.

SECRETIVA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with premature delivery (before 37 weeks gestation)

Other outcome measures

Length of hospital stay of mothers

Length of hospital stay of neonates

SECRETIVA 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,384 Total Patients Enrolled

Media Library

Intervention Arm Clinical Trial Eligibility Overview. Trial Name: NCT05278130 — N/A

Bacterial Vaginosis Research Study Groups: Intervention Arm, Control Arm

Bacterial Vaginosis Clinical Trial 2023: Intervention Arm Highlights & Side Effects. Trial Name: NCT05278130 — N/A

Intervention Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05278130 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants for this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this research endeavor, first advertised on October 20th 2022, is currently recruiting participants. A total of 600 individuals must be sourced from a single medical centre to complete the study."

Answered by AI

Are there any vacancies for participation in this experiment?

"Affirmative. Clinicaltrials.gov information shows that, as of December 7th 2022, this trial is still recruiting participants who initially registered on October 20th 2022. The study needs to collect data from 600 patients at 1 research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Serial Screening and Treatment of Bacterial Vaginosis Trial

Ruofan Yao 2022. "Serial Screening and Treatment of Bacterial Vaginosis Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05278130.

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