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Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

A

Ain Shams Maternity Hospital

Status

Enrolling

Conditions

Uterine Scar

Treatments

Procedure: Monocryl

Study type

Interventional

Funder types

Other

Identifiers

NCT06741371
FMASU MD333/2023

Details and patient eligibility

About

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

Enrollment

140 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

140 participants in 2 patient groups

Monocryl arm
Experimental group
Treatment:
Procedure: Monocryl
Vicryl arm
No Intervention group

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Mourad Faham; Mohammed Hamed, Prof

Data sourced from clinicaltrials.gov

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