Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

ConditionUterine Scar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorAin Shams Maternity Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age: 20-45 years old

Singleton pregnancy.

Gestational age between 37 completed weeks to 42 weeks.

Patients undergoing elective primary caesarean section

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Monocryl

    Procedure/Surgery

    Closure of the uterine scar by monofilament suture material

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Monocryl armExperimental treatment 1 intervention
Group B: Vicryl armNo intervention 0 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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