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

Study Overview
=================
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.

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

Conditions
-----------------
EPO Teqnique in Fetal Head Extraction

Intervention / Treatment
-----------------
* Procedure: conventional cs
* Procedure: external pop out teqnique


Participation Criteria
=================
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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: • Group 1(conventional c s)<br>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<br>* opening the lower uterine segment with introduction of the surgeon hand below the fetal head during its extraction<br>|
| Other: • Group2(EPO technique)<br>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<br>* support of lower uterine segment without introduction of the surgeon hand below the fetal head during its extraction<br>|

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 |