WithdrawnNot Applicable

Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test

Stopped: Business Strategic Decision

United States0Started 2018-03-28

Plain-language summary

A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI).

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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

Inclusion criteria

✓. Subject is ≥ 18 years of age
✓. Subject has singleton gestation
✓. Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
✓. Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:
✓. Cervical dilation \> 2cm
✓. Cervical length of ≤25 mm via transvaginal ultrasound
✓. Subject has onset of contractions was within 48 hours of enrollment in the study
✓. Subject has documented intact amniotic membranes

What they're measuring

performance of vaginal fluid test

Timeframe: 18 months

performance of amniocentesis test

Timeframe: 18 months

Trial details

NCT IDNCT03497234

SponsorHologic, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Intra-Amniotic Infection of Foetus trials