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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-08-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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EPO Teqnique in Fetal Head Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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• 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

Group Type OTHER

No interventions assigned to this group

• 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

Group Type OTHER

No interventions assigned to this group

Interventions

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conventional cs

after opening the lower uterine segment, introduction of the surgeon fingers inside the uterus below the fetal head during its extraction

Intervention Type PROCEDURE

external pop out teqnique

support of lower uterine segment from outside without introduction of the surgeon fingers inside the uterus, guiding the fetal head to pop out from the uterine incision

Intervention Type PROCEDURE

Eligibility Criteria

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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.

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Azhar Samir Aboelfadl

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hisham abou taleb, professor

Role: STUDY_DIRECTOR

Assiut University

Locations

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Faculty of Medicine, Obstetrics and Gynecology department, Assiut University

Asyut, Assiut Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND

PMID: 16260200 (View on PubMed)

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.