Recruiting

NCT Number: NCT06741371

Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

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

Recruiting

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Key information

Conditions

Uterine Scar

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Cairo, Abbasya, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Monocryl

Procedure

Closure of the uterine scar by monofilament suture material

Primary outcomes

The incidence of isthmocele by transvaginal ultrasound 6 months after delivery

Time frame: 6 months

Effect of using monofilament sutures on the development of uterine scar niche

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Hamed, Prof

CONTACT

01226067272 ext. 202

Mourad Faham

CONTACT

[email protected]

01095830113 ext. 202

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 19, 2024
Registry last updated: Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed