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ClinicalTrials.gov ID

NCT06695793

Lead Sponsor

Cairo UniversityOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

225Estimated

Last Update Posted

Nov 19, 2024Actual

Start Date

Nov 1, 2024Actual

Primary Completion Date

May 1, 2026Estimated

Completion Date

Nov 1, 2026Estimated

Official Title

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

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

• Caesarean Scar Niche

• Interrupted Sutures
• Locked Sutures
• Running Continuous Sutures

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Cairo UniversityOTHER

Dr_abdallamousa@yahoo.com+201277664430

mizoelsherbini@yahoo.com+20100158300

dr_mahmoudsoliman@yahoo.com+201222251268

ibrahimfawzyibrahimfawzy@gmail.com+201062641235