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

Not Applicable

Completed

• Conditions: Caesarean Section
• Interventions: Procedure: Classic technique; Procedure: External Pop-Out Cesarean Section

• Registration Number: NCT02755168
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-23
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Study Start: 2017-05-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic technique	Classic technique	-
External Pop-Out Cesarean Section	External Pop-Out Cesarean Section	-

Primary Outcome Measures

Name	Time	Method
The success rate of External POP out technique	20 minutes

Secondary Outcome Measures

Name	Time	Method
Time of head extraction	5 minutes
Number of women will need blood transfusion	24 hours
Easiness score:	5 minutes	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.

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt