Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer

Stopped early · Not applicable

Conditions studied: Cesarean Section

In brief

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.

Key facts

Study ID: NCT02167438
Run by: Stetrix, Inc.
People needed: 117
Starts: 2014-10-01
Expected to finish: 2016-12-01
Last updated by the study team: 2017-03-22

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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)
Previous Cesarean Section
PTL (preterm labor)
Known major fetal anomaly or fetal demise.
Suspected or proven chorioamnionitis
Placenta previa
Maternal insulin dependent diabetes
Maternal health conditions deemed as risk factors by investigators such as renal or cardiopulmonary disease

Where it is running

Saint Francis Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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