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

NCT02755168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-07-31

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Classic technique

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-08-01
Completion
2020-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755168 on ClinicalTrials.gov