External Pop Out cs vs Conventional Method for Fetal Head Extraction in Repeatedcaesarean Section. (EPO)

External Pop Out Caesarean Section Versus Conventional Method for Fetal Head Extraction in Repeated Caesarean Section, a Randomized Controlled Trial.

To establish feasibility and safety of the use of external pop out as a novel technique for foetal head delivery during c s, the effect of application of this method on a previously scarred uterus will be studied as a better way regarding preservation of the integrity of the lower uterine segment, operative time, time needed for head delivery, incision extension, blood loss, incidence of bladder injury.

Study Overview

• Status: Completed
• Conditions: EPO Teqnique in Fetal Head Extraction
• Intervention / Treatment: Procedure: conventional cs; Procedure: external pop out teqnique

Detailed Description

Caesarean delivery (cs) is the most common major surgical procedure performed with over 1,2million performed per year . The increase in caesarean section rates seems uncontrollable with no signs that it is slowing down .

A great concern of caesarean delivery complications is incision extension , un intended extensions of uterine incision frequently occurs at the time of caesarean delivery with estimated incidence of 4-8% .

Some measures are taken to guard against incision extension as expansion of uterine incision in cephalocaudal direction which is associated with lower risk of un intended extension Head extraction during caesarean section is one of the most critical steps during caesarean section and one of the major contributors to un intended uterine incision extension . Delivery of the foetal head should be within 3minutes from opening the uterine incision.

Difficult extraction causes different hazards as foetal respiratory distress syndrome , incision extension, bleeding.

The original technique of foetal head extraction entails introduction of obstetrician hands or other instruments into lower uterine segment (LUS) .

Criticizing the standard:

Insertion of obstetrician hand inside the uterine incision will occupy more space and this will increase possibility of incision extension and puts the LUS at risk of damage and increased blood loss, increased operative time , Interfere with head rotation &repositioning of the head may happen during head delivery leading to difficult extraction.

Inadequate opening will add more pressure on uterine incision increasing possibility of extension.

In cases of repeated c s , lower uterine segment is thin, adherent to the urinary bladder this makes the conventional method of head extraction unreliable causing more bleeding, extension, bladder injury, more operative time, postoperative adhesions.

The rational of EPO technique:

Support of the lower uterine segment and bladder without introduction of the obstetrician hand in the uterine incision so as not to occupy more space ; this help rotation of the foetal head facilitating head delivery, protecting LUS incision from extension.

Preoperative sonographic assessment of the lower uterine segment thickness will be done within two weeks of delivery using transabdominal us with critical cut off value of 2.5 mm which is associated with dehiscent scar according to ROC curve.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut Governorate
    • Asyut, Assiut Governorate, Egypt
      • Faculty of Medicine, Obstetrics and Gynecology department, Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Cases with repeated c s.
• Elective c s.
• Singleton pregnancy.

• Full term pregnancy.

  -BMI below30

• Cephalic presentation.
• Women who accepted to participate in the study.
• Placenta away from the lower segment

Exclusion Criteria:

• Fibroid uterus.
• Infection as chorioamnionitis.
• Maternal comorbidities.
• Uterine anomalies.
• Major Foetal congenital anomalies.
• Placenta previa.

Placental separation.

Dehiscent LUS scar as assessed by us with cut off value 2.5mm.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: • Group 1(conventional c s); this arm will be exposed to the conventional method of cesserian section which entail introduction of the operator hand below the fetal head during its extraction	Procedure: conventional cs; opening the lower uterine segment with introduction of the surgeon hand below the fetal head during its extraction
Other: • Group2(EPO technique); this group will be exposed to external pop out teqnique which entails support of lower uterine segment without introduction of the obstetrician hand into uterine incision	Procedure: external pop out teqnique; support of lower uterine segment without introduction of the surgeon hand below the fetal head during its extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of uterine incision extension or LUS injury	The percentage of participants who developed uterine incision extension or lower uterine segment injury in both groups of study.	through the study completion average one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of severity of incision extension or injury	measuring the extension or injury in cm or associated bladder or uterine artery injury	through the study completion average one year
Amount of intraoperative blood loss	Number of towels used in the hemostasis during repair of the incison or an extension/injury	through the study completion average one year
Total operative time and uterotomy to head delivery time	Total time of whole surgery and the time from uterine incision and head delivery in minutes	through the study completion average one year
Post operative hemoglobin level	Estimation of HB level (gm/dl) after 24 hours postoperative	24 hours postoperative in each participant through the study completion average one year
Need for blood transfusion	excessive intraoperative blood loss or affected vitals of the patient	Intraoperative or postoperative before discharge from the hospital
Hospital stay	Postoperative hospital stay in days	Through the study completion average one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Hisham abou taleb, professor, Assiut University

Publications and helpful links

General Publications

• Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
• Fioretti BT, Reiter M, Betran AP, Torloni MR. Googling caesarean section: a survey on the quality of the information available on the Internet. BJOG. 2015 Apr;122(5):731-9. doi: 10.1111/1471-0528.13081. Epub 2014 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): July 24, 2022
• Study Completion (Actual): August 28, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EPO technique

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The anonymized participants data and study protocols can be shared after publication when reasonably requested .These data will be available also for other qualified researchers after publication as an accessory data at the site of publishing journal.
• IPD Sharing Time Frame: After publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No