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OpenTrials
Completed

NCT Number: NCT02755168

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

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Classic technique

Procedure

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

Primary outcomes

  1. The success rate of External POP out technique

    Time frame: 20 minutes

Secondary outcomes

  1. Number of women will need blood transfusion

    Time frame: 24 hours

  2. Time of head extraction

    Time frame: 5 minutes

  3. Easiness score:

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2016
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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