Back to resultsReverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix
Primary Purpose
Obstructed Labor at Second Stage of Labor
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
reverse breech extraction technique or push technique
Sponsored by
About this trial
This is an interventional treatment trial for Obstructed Labor at Second Stage of Labor
Eligibility Criteria
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
Sites / Locations
- Faculty of Medecine At Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Women allocated to this group will deliver by using reverse breech extraction technique.
Women allocated to this group will deliver by using Push technique.
Arm Description
Outcomes
Primary Outcome Measures
Uterine incision extension
uterine extensions will include angle extensions on lower segments and into the broad ligaments".
Secondary Outcome Measures
Full Information
NCT ID
NCT05707650
First Posted
January 15, 2023
Last Updated
January 22, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05707650
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructed Labor at Second Stage of Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Women allocated to this group will deliver by using reverse breech extraction technique.
Arm Type
Active Comparator
Arm Title
Women allocated to this group will deliver by using Push technique.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
reverse breech extraction technique or push technique
Intervention Description
using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix
Primary Outcome Measure Information:
Title
Uterine incision extension
Description
uterine extensions will include angle extensions on lower segments and into the broad ligaments".
Time Frame
intra-operative
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ebtihal ahmed, baccalaureus
Phone
01062477324
Email
betoooo_b2@yahoo.com
Facility Information:
Facility Name
Faculty of Medecine At Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ebtihal ahmed, baccalarous
Phone
01062477324
Email
betoooo_b2@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
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
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