Clinical trial NCT05385276: Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women
Official title: Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women "A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 today, thus any useful refinement in the operative technique, however minimal, is likely to yield substantial benefits.

In morbidly obese women with a panniculus, the supraumbilical incision is a new technique that showed definite advantages over the Pfannenstiel incision that will avoid burying the wound under a large panniculus and affords excellent abdominal exposure, less blood loss, less post-operative pain, earlier ambulation, and shorter hospital stay. All these advantages were attributed to minimal tissue manipulation.

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, and logistical challenges.

The rapid upswing in obesity prevalence across nations, ages, and ethnic groups has reached alarming and pandemic proportions.

The prevalence of morbid obesity (BMI\>40 kg/m2) has increased by 50% between 2000 and 2005, with 8% of women in the reproductive age group being morbidly obese.

The percentage of women with a body mass index (BMI) of 50 Kg/m2 or more has increased five-fold in 20 years. Obesity is currently the most prevalent health threat the world over and its influence on general health is rapidly increasing.

The incidence of pregnancy-related pathology is higher in obese patients. Obstetricians are often confronted with difficult decisions when such patients are about to give birth. Indeed, in obese patients, labor is induced twice as frequently and vaginal delivery has to be interrupted more frequently due to an abnormal fetal heart rate or fetopelvic disproportion.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Mean operative time
timeFrame: during the procedure
Secondary outcomes:
measure: Mean Intra-operative blood loss
timeFrame: during the procedure
measure: Occurrence of Post-operative Surgical site infection
timeFrame: 7 days
measure: Occurrence of surgical complications
timeFrame: during the operation
measure: Mean hospital stay
timeFrame: 3 days postoperatively
measure: VAS score of pain
timeFrame: 24 hours
measure: Mean Intra-operative blood loss
timeFrame: During the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Mohamed Hamed, MD
role: PRINCIPAL_INVESTIGATOR
References: