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

NCT06695793 | Recruiting

• 1 other identifier: MD-308-2024
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Caesarean Scar Niche

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Operative time

  during operation

• Estimate blood loss

  during operation

Study Arms (3)

Group (A)

EXPERIMENTAL

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

Group (B)

EXPERIMENTAL

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

Group (C)

EXPERIMENTAL

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

Interventions

Interrupted Sutures PROCEDURE

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.

Group (A)

Locked Sutures PROCEDURE

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.

Group (B)

Running Continuous Sutures BIOLOGICAL

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.

Group (C)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)
• Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
• Current smokers.
• Non-cephalic presentation of the fetus.
• Low-lying anterior wall placenta and placenta previa.
• Inability to provide informed consent (e.g., cognitive impairment, language barrier)
• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (5)

Cairo University

Cairo, Egypt

RECRUITING

Cairo University

Cairo, Egypt

RECRUITING

Cairo University

Cairo, Egypt

RECRUITING

Cairo University

Cairo, Egypt

RECRUITING

Cairo University

Cairo, Egypt

RECRUITING

Central Study Contacts

Abdalla Moussa

CONTACT

+20127664430; Dr_abdallamousa@yahoo.com

Sally Collins

CONTACT

+44 7958 656885; sally.collins@wrh.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obgyn Cairo university

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

EG (5)