EPO Teqnique in Fetal Head Extraction
Conditions
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.
Interventions
PROCEDUREconventional cs
after opening the lower uterine segment, introduction of the surgeon fingers inside the uterus below the fetal head during its extraction
PROCEDUREexternal 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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of uterine incision extension or LUS injury | through the study completion average one year | The percentage of participants who developed uterine incision extension or lower uterine segment injury in both groups of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The degree of severity of incision extension or injury | through the study completion average one year | measuring the extension or injury in cm or associated bladder or uterine artery injury |
| Amount of intraoperative blood loss | through the study completion average one year | Number of towels used in the hemostasis during repair of the incison or an extension/injury |
| Total operative time and uterotomy to head delivery time | through the study completion average one year | Total time of whole surgery and the time from uterine incision and head delivery in minutes |
| Need for blood transfusion | Intraoperative or postoperative before discharge from the hospital | excessive intraoperative blood loss or affected vitals of the patient |
| Hospital stay | Through the study completion average one year | Postoperative hospital stay in days |
| Post operative hemoglobin level | 24 hours postoperative in each participant through the study completion average one year | Estimation of HB level (gm/dl) after 24 hours postoperative |
Countries
Egypt
Outcome results
None listed