Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer

NCT02167438 | Terminated

• 1 other identifier: PB_004
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section

Keywords

Cesarean; Section; second; stage; labor

Outcome Measures

Primary Outcomes (1)

• Measuring the reduction in Cesarean section rates.

  This study is a single-site, prospective, randomized, concurrently-controlled study. Subjects will undergo screening to determine their enrollment eligibility. All subjects who meet inclusion criteria will be offered participation in this study.

  12 Months

Secondary Outcomes (1)

• Measuring the reduction of second-stage of labor times.

  12 Months

Study Arms (2)

Investigational

EXPERIMENTAL

Application of the Hem-Avert device.

Device: Hem-Avert Perianal Stabilizer

Control

NO INTERVENTION

No Application of the Hem-Avert device.

Interventions

Hem-Avert Perianal Stabilizer DEVICE

Investigational

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Stetrix, Inc.: lead

Study Sites (1)

Saint Francis Hospital

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)