Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)

This study aims to explore the impact of three different suturing techniques (Running, Interrupted & Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche

Study Overview

• Status: Recruiting
• Conditions: Caesarean Scar Niche
• Intervention / Treatment: Procedure: Interrupted Sutures; Procedure: Locked Sutures; Biological: Running Continuous Sutures

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdalla Moussa; Phone Number: +20127664430; Email: Dr_abdallamousa@yahoo.com
• Study Contact Backup: Name: Sally Collins; Phone Number: +44 7958 656885; Email: sally.collins@wrh.ox.ac.uk

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Ibrahim Fawzy; Phone Number: +201062641235; Email: ibrahimfawzyibrahimfawzy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women with a singleton pregnancy scheduled for elective cesarean section
2. Gestational age at the time of cesarean section between 38 and 40 weeks.
3. Willingness to participate in the study and provide informed consent
4. Age between 18 and 35 years old.
5. BMI <30

Exclusion Criteria:

1. Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)
2. Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
3. Current smokers.
4. Non-cephalic presentation of the fetus.
5. Low-lying anterior wall placenta and placenta previa.
6. Inability to provide informed consent (e.g., cognitive impairment, language barrier)
7. Any condition deemed by the attending physician to pose a risk to the participant or compromise the study's integrity, for example, Patients who will require excessive suturing for further hemostasis or those who require ligation of one or both uterine arteries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (A); Interrupted Sutures: The first layer of the uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures.	Procedure: Interrupted Sutures; The first layer of uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures.
Experimental: Group (B); Locked Sutures: The first layer of the uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures.	Procedure: Locked Sutures; The first layer of uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures.
Experimental: Group (C); Running Continuous Sutures: Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length.	Biological: Running Continuous Sutures; Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of caesarean scar niche and its dimensions.	Follow-up visits will be scheduled at 6-12 weeks post-cesarean section to assess caesarean section niche formation using trans-vaginal ultrasound using Samsung Elite with endovaginal probe of frequency 6 - 12 MHz. Trained sonographers, blinded to the participants' suturing group, will perform the ultrasound examinations to evaluate caesarean section niche presence and its dimensions.	6-12 weeks post-cesarean section

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative time	during operation
Estimate blood loss	during operation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MD-308-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No