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 range18 Years

SexFEMALE

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

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 range18 Years

SexFEMALE

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)