External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section

Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section

Caesarean section is one the most common operations worldwide, its rates are globally increasing. A multitude of efforts had been done aiming at reduction of Caesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions . The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8% .

The vulnerability of the lower uterine segment for tears are related to stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.

The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment . This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection adhesions and blood transfusion. Adherence to the available the generated good quality evidence bases practice in Caesarean section is anticipated to decease such morbidities.

The idea of the present technique was derived from the fact that during vaginal delivery the main task of obstetrician is to support the perineum while the fetal head extends to get out through birth canal.

Study Overview

• Status: Unknown
• Conditions: Caesarean Section
• Intervention / Treatment: Procedure: External Pop-Out Cesarean Section; Procedure: Classic technique

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Assiut University
    • Contact: MOhammed k Ali, MD; Phone Number: 0882414616; Email: m_khairy2001@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• single fetus
• more than 37 weeks of gestation
• elective Caesarean section

Exclusion Criteria:

• non-cephalic presentation
• placenta previa
• hydrocephalus
• Multiple pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: External Pop-Out Cesarean Section	Procedure: External Pop-Out Cesarean Section; During fetal head extraction, the obstetrician puts four fingers of his right hand on the lower segment at uterovesical pouch. The palmar aspect of the fingers will be resting on the uterovesical peritoneal reflection not on directly on the fetal head. While the palmar aspect of the fingers was facing the lower segment they were pushed deep below the fetal head.
Other: Classic technique	Procedure: Classic technique; During fetal head extraction, the obstetrician puts four fingers of his right hand inside the uterus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success rate of External POP out technique	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women will need blood transfusion		24 hours
Time of head extraction		5 minutes
Easiness score:	The ES was calculated at a graduated Likert-type scale from zero to 100; in which zero means terribly difficult and 100 means very easy.	5 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: April 23, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 29, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: EPO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No