Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support (EPO)

May 11, 2020 updated by: Ahmed Mohamed Abbas, Assiut University

Delivery of Fetal Head During Cesarean Section; Acceptability and Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support; A Cross- Sectional Study

Cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%(

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

B. Eligible women who will present to the hospital and fulfill the inclusion criteria during the study period will be enrolled in the study.

Description

Inclusion Criteria:

  1. Singleton term pregnancy
  2. Cephalic presentation
  3. Women who will accept to participate in the study

Exclusion Criteria:

  1. Non-cephalic presentation
  2. Congenital fetal anomalies
  3. Multiple pregnancy
  4. Preterm caesarean < 37 weeks
  5. Cases with marked adhesions obscuring the lower uterine segment thickness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of cesarean sections that are required for the obstetrician to reach turning point .
Time Frame: 1 month
the number needed to achieve a good learning curve
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • EPOLC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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