Clinical trial NCT04968340: External Pop Out cs vs Conventional Method for Fetal Head Extraction in Repeatedcaesarean Section.
Official title: External Pop Out Caesarean Section Versus Conventional Method for Fetal Head Extraction in Repeated Caesarean Section, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: EPO Teqnique in Fetal Head Extraction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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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Primary outcomes:
measure: intact lower uterine segment
timeFrame: through the study completion average one year
Secondary outcomes:
measure: incidence of incision extensions infection
timeFrame: through the study completion average one year
measure: intraoperative blood loss related to repaire of the incision
timeFrame: through the study completion average one year
measure: operative time
timeFrame: through the study completion average one year
measure: fetal wellbeing
timeFrame: through the study completion average one year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hisham abou taleb, professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.