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A Trial to Reduce Adhesions Following a Primary Cesarean Section

NCT01819467 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-08-16

Study results available
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Summary

The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section.

A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.

Conditions

  • Tissue Adhesions

Interventions

DEVICE

Seprafilm

Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section

Sponsors & Collaborators

  • New Hanover Regional Medical Center

    collaborator OTHER

  • South East Area Health Education Center, Wilmington, NC

    lead OTHER

Principal Investigators

  • Henry A Easley, MD · South East Area Health Education Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819467 on ClinicalTrials.gov