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

Caesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755168
• Other study ID #: EPO
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2016
• Last updated: July 29, 2017
• Start date: May 1, 2017
• Est. completion date: May 2018

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• single fetus

• more than 37 weeks of gestation

• elective Caesarean section

Exclusion Criteria:

• non-cephalic presentation

• placenta previa

• hydrocephalus

• Multiple pregnancy

Related Conditions & MeSH terms

• Caesarean Section

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of External POP out technique		20 minutes
Secondary	Number of women will need blood transfusion		24 hours
Secondary	Time of head extraction		5 minutes
Secondary	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