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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06741371

Enrollment

140

Registered

2024-12-19

Start date

2024-01-01

Completion date

2025-03-01

Last updated

2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Scar

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

Interventions

PROCEDUREMonocryl

Closure of the uterine scar by monofilament suture material

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactMohammed Hamed, Prof

01226067272

Backup ContactMourad Faham

Muradmostafa@med.asu.edu.eg01095830113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026