RecruitingNot ApplicableNCT06741371

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


Sponsor

Ain Shams Maternity Hospital

Enrollment

140 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 45 Years

Inclusion Criteria4

  • Age: 20-45 years old
  • Singleton pregnancy.
  • Gestational age between 37 completed weeks to 42 weeks.
  • Patients undergoing elective primary caesarean section

Exclusion Criteria5

  • 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)

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Interventions

PROCEDUREMonocryl

Closure of the uterine scar by monofilament suture material


Locations(1)

Faculty of medicine

Cairo, Abbasya, Egypt

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NCT06741371