ClinicalTrials.gg
RecruitingNCT06741371Updated Dec 19, 2024

Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

An interventional study of Monocryl in Uterine Scar, sponsored by Ain Shams Maternity Hospital. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Jan 2024, registered Dec 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Uterine Scar

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03

In context

Cicatrix

611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.

This study's planned enrollment of 140 is above the median of 40 across 512 interventional studies indexed under Cicatrix.

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Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, drugs and chronic use of (more than 14 days pre-operative)
    • Any medical Co-morbidity (diabetes mellitus, Hypertension and Thyroid abnormalities) (more liable to affect the healing)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Monocryl arm

    Procedure: Monocryl

  • No intervention
    Vicryl arm

Interventions

  • ProcedureMonocryl

    Closure of the uterine scar by monofilament suture material

06

What researchers measure

Primary outcomes

  1. The incidence of isthmocele by transvaginal ultrasound 6 months after delivery

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine
    Cairo, Abbasya, Egypt
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06741371
Responsible party
Mohammed Essam ElDin Mohammed (Assistant lecturer, Ain Shams Maternity Hospital) — Principal investigator
First posted
Dec 19, 2024
Start date
Jan 1, 2024
Primary completion
Jan 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Dec 19, 2024

Study contacts

Mohammed Hamed, Prof
Contact
01226067272 ext. 202
Mourad Faham
Contact
Muradmostafa@med.asu.edu.eg
01095830113 ext. 202

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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