TerminatedNot Applicable

The Association Between the Transfer of Lactobacilli From the Gastrointestinal Tract to the Vagina and the Prevention / Eradication of Abnormal Vaginal Flora in High Risk Pregnancies

Stopped: After completing the part of assessing lactobacilli transfer, it was decided not to proceed further with the masked part of the study.

Israel40 participantsStarted 2016-01

Plain-language summary

Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV) by taking vaginal smear. Treatment will be given according to the results.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pregnant women from at least 13 weeks of gestation with a risk factor for preterm labor Exclusion Criteria: * Women with preterm premature rupture of the membranes * Immunocompromised women * Planned elective preterm birth for reasons other than preterm premature rupture of membranes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The amount of lactobacilli in the vaginal

Timeframe: once a month until week 36.6 of labor

The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period

Timeframe: From date of randomization until the date of first documented episode or until delivery (around 4 months)

The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period

Timeframe: From date of randomization until the date of first documented episode or until delivery (around 4 months)

The rate of women with AVF/BV at enrollment whose infection was not eradicated following antibiotics, who restored the normal vaginal flora during the study period

Timeframe: Until delivery (around 4 months)

Trial details

NCT IDNCT02430246

SponsorHaEmek Medical Center, Israel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03-14

View on ClinicalTrials.gov More Pregnancy trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The amount of lactobacilli in the vaginal

Timeframe: once a month until week 36.6 of labor

The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period

Timeframe: From date of randomization until the date of first documented episode or until delivery (around 4 months)

The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period

Timeframe: From date of randomization until the date of first documented episode or until delivery (around 4 months)

The rate of women with AVF/BV at enrollment whose infection was not eradicated following antibiotics, who restored the normal vaginal flora during the study period

Timeframe: Until delivery (around 4 months)