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

NCT02755168 | Completed

• 1 other identifier: EPO
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Caesarean Section

Outcome Measures

Primary Outcomes (1)

• The success rate of External POP out technique

  20 minutes

Secondary Outcomes (3)

• Number of women will need blood transfusion

  24 hours

• Time of head extraction

  5 minutes

• Easiness score:

  5 minutes

Study Arms (2)

External Pop-Out Cesarean Section

OTHER

Procedure: External Pop-Out Cesarean Section

Classic technique

OTHER

Procedure: Classic technique

Interventions

External Pop-Out Cesarean Section PROCEDURE

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.

External Pop-Out Cesarean Section

Classic technique PROCEDURE

During fetal head extraction, the obstetrician puts four fingers of his right hand inside the uterus.

Classic technique

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: April 28, 2016
• Study Start: May 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: November 1, 2020
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

EG (1)