NCT01739543

Brief Summary

A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

November 29, 2012

Last Update Submit

March 14, 2013

Conditions

Complications; Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Reduce C-section Rate

    The primary objective (purpose) of this study is to evaluate the success rate of the HEM-AVERT® device as a method of reducing C-section rates

    24 hours

Secondary Outcomes (1)

  • Reduce duration of 2nd stage of labor.

    24 hours

Study Arms (2)

Investigational

EXPERIMENTAL

Subject receives Hem-Avert Device.

Device: Hem-Avert

Control

NO INTERVENTION

Subject does not receive Hem-Avert Device.

Interventions

Hem-AvertDEVICE

Application of Hem-Avert

Also known as: Hem-Avert Perianal Stabilizer
Investigational

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is scheduled for vaginal delivery.
  • Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form.
  • Subjects' pre-natal examination indicates that this is to be a single birth delivery.

You may not qualify if:

  • Subject's scheduled for vaginal delivery with anticipated complications.
  • Subject is unable to understand and sign the informed consent form.
  • Subject does not deliver at study facility (hospital).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niagara Falls Memorial Medical Center

Niagara Falls, New York, 14301, United States

Location

Related Publications (1)

  • Burns DA. Effectiveness of a novel device in the reduction of cesarean deliveries. ISRN Obstet Gynecol. 2013 Sep 1;2013:173278. doi: 10.1155/2013/173278. eCollection 2013.

    PMID: 24078876DERIVED

Study Officials

  • Dan Burns, M.D.

    Unafilliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)