Best Incision in Cesarean Section of Obese Women

Status Completed

Clinical Trial Summary

The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are: Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery. Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.

Clinical Trial Description

This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined as pre-pregnancy body mass index ≥40 kg/m2. Patients will be randomly allocated to one of two groups (30 patients per group): Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision 2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus sheath in the same line as the skin incision, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment. Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, followed by transverse incision of the anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment. The primary outcome measures will be operative time, estimated blood loss, post-operative pain scores, and wound complication rates. Secondary outcomes will include length of hospital stay, patient satisfaction scores, and cosmetic results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06032637
Study type	Interventional
Source	Al-Azhar University
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2022
Completion date	October 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.