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

Cairo University (CU)

Status: Enrolling

Conditions: Caesarean Scar Niche

Treatments: Biological: Running Continuous Sutures; Procedure: Locked Sutures; Procedure: Interrupted Sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT06695793

MD-308-2024

Details and patient eligibility

About

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

Enrollment: 225 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

Group (A)

Experimental group

Description:

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.

Treatment:

Procedure: Interrupted Sutures

Group (B)

Experimental group

Description:

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.

Treatment:

Procedure: Locked Sutures

Group (C)

Experimental group

Description:

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.

Treatment:

Biological: Running Continuous Sutures