Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

Not Applicable

Recruiting

• Conditions: Uterine Scar

• Registration Number: NCT06741371
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section.

The difference between monofilament and multifilament sutures and the special properties of each one .

The primary outcome of the study is to know which material conducts more scar niche formation .

Secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Age: 20-45 years old

  • Singleton pregnancy.
  • Gestational age between 37 completed weeks to 42 weeks.
  • Patients undergoing elective primary caesarean section

Exclusion Criteria

• History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent CS scar and the old scar)

  • Abnormal placental invasion (placenta previa and accrete ) ( more liable to undergo Cesarean hysterectomy)
  • Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids). (may be localized at the suture line and therefore affect the scar)
  • Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative)
  • Any medical Co-morbidity (diabetes mellitus, Hypertension and Thyroid abnormalities) (more liable to affect the healing)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery	6 months	Effect of using monofilament sutures on the development of uterine scar niche

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Cairo, Abbasya, Egypt