Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix

January 22, 2023 updated by: Ebtihal Ahmed, Ain Shams University

Management of impacted fetal head during second stage cesarean requires careful and gentle attention to various surgical steps for delivery of a fetus without adverse maternal and neonatal outcomes, mostly by an experienced surgeon as in such situations, the lower uterine segment may be over-distended and indistinguishable from the vagina. Therefore, the uterine incision may inadvertently be placed too low, or in the vagina.

Also, it may be difficult for the operating surgeon to maneuver his hand below the deeply engaged fetal head, which may be further compounded by the presence of molding and edema on the fetal head (caput succedaneum).

This prospective controlled study was conducted at labor ward of department of obstetrics and gynecology at Ain Shams University Maternity Hospital to compare between the two techniques. A total of 70 pregnant women were enrolled and divided into two equal groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Medecine At Ain Shams University
        • Contact:

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • Singleton pregnancies.

    • Cephalic presentation will undergo cesarean section in advanced labor with the fetal head deeply engaged in the pelvis defined as fully dilated cervix and vertex at or below zero station

Exclusion Criteria:

  • • Twins Pregnancies.

    • Breech or transverse presentation.
    • Woman has other obstetric indication to cs ex, fetal distress.
    • Woman has risk factor for bleeding ex, bleeding disorders

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Women allocated to this group will deliver by using reverse breech extraction technique.
Procedure: reverse breech extraction technique or push technique
using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix
ACTIVE_COMPARATOR: Women allocated to this group will deliver by using Push technique.
Procedure: reverse breech extraction technique or push technique
using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine incision extension
Time Frame: intra-operative
uterine extensions will include angle extensions on lower segments and into the broad ligaments".
intra-operative

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

January 1, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS492/2021

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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