Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

Impact of Using Synthetic Absorbable Monofilament Versus Multifilament Suture Material for Uterine Closure on the Development of Uterine Isthmocele : A Rondamized Controlled Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Uterine Scar
• Intervention / Treatment: Procedure: Monocryl

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed Hamed, Prof; Phone Number: 202 01226067272
• Study Contact Backup: Name: Mourad Faham; Phone Number: 202 01095830113; Email: Muradmostafa@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasya
    • Cairo, Abbasya, Egypt
      • Recruiting
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monocryl arm	Procedure: Monocryl; Closure of the uterine scar by monofilament suture material
No Intervention: Vicryl arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery	Effect of using monofilament sutures on the development of uterine scar niche	6 months

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD333/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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