Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women

NCT ID: NCT05385276

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-02-01

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transverse supraumbilical incision

The skin incision will be performed as a straight transverse skin incision 3-5cm above the umbilicus after maximum retraction of the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment.

Group Type: EXPERIMENTAL

Transverse supraumbilical incision

Intervention Type: PROCEDURE

The skin incision will be performed as a straight transverse skin incision 3-5cm above umbilicus after maximum retraction the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm) .

Pfannenstiel Incision

The skin incision is a transverse upward concavity, typically initiated two finger breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).

Group Type: EXPERIMENTAL

Pfannenstiel Incision

Intervention Type: PROCEDURE

The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).

Interventions

Transverse supraumbilical incision

The skin incision will be performed as a straight transverse skin incision 3-5cm above umbilicus after maximum retraction the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm) .

Intervention Type: PROCEDURE

Pfannenstiel Incision

The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mahmoud Arafa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Hamed, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Arafa, MSc

Role: CONTACT

mohamedarafa1991@gmail.com

01022728663

Mohamed Hamed, MD

Role: CONTACT

01226067272

Facility Contacts

Mohamed Arafa, MSc

Role: primary

Mohamed Hamed, MD

Role: backup

Other Identifiers

07052022

Identifier Type: -

Identifier Source: org_study_id