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

A

Assiut University

Status

Unknown

Conditions

Caesarean Section

Treatments

Procedure: Classic technique
Procedure: External Pop-Out Cesarean Section

Study type

Interventional

Funder types

Other

Identifiers

NCT02755168
EPO

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

single fetus more than 37 weeks of gestation elective Caesarean section

Exclusion criteria

non-cephalic presentation placenta previa hydrocephalus Multiple pregnancy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

External Pop-Out Cesarean Section
Other group
Treatment:
Procedure: External Pop-Out Cesarean Section
Classic technique
Other group
Treatment:
Procedure: Classic technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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