Status:
UNKNOWN
Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women
Lead Sponsor:
Ain Shams Maternity Hospital
Conditions:
Cesarean Section Complications
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
cesarean section is one of the most common operative procedures performed in modern obstetrics, that become increasingly common in both developed and developing countries for a variety of reasons toda...
Detailed Description
The prevalence of obesity has reached pandemic proportions across nations. Morbid obesity has a dramatic impact on pregnancy outcomes. Cesarean section in these women poses many surgical, anesthetic, ...
Eligibility Criteria
Inclusion
- Patients presenting with morbid obesity (BMI \> 40)
- Patients with an abdominal panniculus covering the supra pubic skin crease.
- Patients with a singleton pregnancy.
- All indications for elective cesarean section.
- Hemoglobin ≥ 10 g/dl.
- Since obesity is a disease associated commonly with co-morbidities such as diabetes mellitus, hypertension and sometimes chest problem these conditions will not be excluded, despite being significant factors that may affect wound healing and this will be analyzed in subgroups.
- Preoperative glycemic control (HbA1C level \< 7 percent) for women with diabetes.
Exclusion
- Antepartum Hemorrhage and placenta previa (more bleeding and operative time anticipated will interfere with the interpretation of operative date)
- Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative).
- Multiple gestation (higher blood loss is anticipated).
- Patients diagnosed with intra amniotic infections (infections increases bleeding and incidence for post-operative infections).
- Patients with (HELLP syndrome) hemolysis, elevated liver enzymes and low platelets or bleeding disorders (the need for blood and blood products is higher than average).
- Patients with bleeding disorders or auto immune diseases (both affects bleeding and time needed for hemostasis as well as tissue healing).
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05385276
Start Date
May 1 2021
End Date
February 1 2023
Last Update
May 23 2022
Active Locations (1)
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1
Ain Shams University Maternity Hospital
Cairo, Egypt, 11865