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

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: Not yet recruiting
• 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 (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: azhar samir, master; Phone Number: 01024514152; Email: azharsmyr8@gmail.com
• Study Contact Backup: Name: Ali Elsaman., professor; Phone Number: 01004137041; Email: ali_elsaman@yahoo.com

Participation Criteria

Eligibility Criteria

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

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
intact lower uterine segment	lenght of lower uterine segment in centimeters after head extraction .number of participants with uterine artery injury during cs.	through the study completion average one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of incision extensions infection	number of participants with rt or lt incision extension after fetal head extraction	through the study completion average one year
intraoperative blood loss related to repaire of the incision	number of towels used in the hemostasis during the repaire of the incison . post operative hemoglobin in gm/dl	through the study completion average one year
operative time	total time of surgery	through the study completion average one year
fetal wellbeing	apgar score of the fetus	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 (Anticipated): April 16, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 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): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EPO teqnique

Drug and device information, study documents

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