TerminatedNot Applicable

Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer

Stopped: Lack of enrollment

United States117 participantsStarted 2014-10

Plain-language summary

This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Inclusion criteria

✓. Pregnant women between the ages of 18 and 40 years old at the time of enrollment
✓. Gestational age between 34 and 42 weeks at the time of enrollment
✓. Live singleton gestation
✓. Candidate for vaginal delivery.
✓. Willing and able to comply with the study plan as indicated by understanding and signing the subject informed consent form

Exclusion criteria

✕. Subject unable to speak English
✕. Subject unable to understand and sign the informed consent form
✕. Delivery planned outside the clinical center
✕. Subject is scheduled for vaginal delivery with anticipated complications (i.e. including but not limited to non-vertex presentation or macrosomia \>4,000 grams)
✕. Subject scheduled for an elective cesarean birth
✕. Preeclampsia with severe features, eclampsia, HELLP syndrome
✕. Multiple Gestation
✕. PROM (premature rupture of membranes)

What they're measuring

Measuring the reduction in Cesarean section rates.

Timeframe: 12 Months

Trial details

NCT IDNCT02167438

SponsorStetrix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Cesarean Section trials