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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02755168
Collaborator
(none)
500
1
2
12
41.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: External Pop-Out Cesarean Section
  • Procedure: Classic technique
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section
Actual Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: External Pop-Out Cesarean Section

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.

Other: Classic technique

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

Outcome Measures

Primary Outcome Measures

  1. The success rate of External POP out technique [20 minutes]

Secondary Outcome Measures

  1. Number of women will need blood transfusion [24 hours]

  2. Time of head extraction [5 minutes]

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • single fetus

  • more than 37 weeks of gestation

  • elective Caesarean section

Exclusion Criteria:
  • non-cephalic presentation

  • placenta previa

  • hydrocephalus

  • Multiple pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Khairy Ali, lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT02755168
Other Study ID Numbers:
  • EPO
First Posted:
Apr 28, 2016
Last Update Posted:
Aug 1, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 1, 2017