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Completed

NCT Number: NCT04871022

Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

1. Double layer unlocked suture; 2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

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Key information

Conditions

Uterine Scar Defect

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Mongi Slim la Marsa

Tunis, La Marsa, 2046, Tunisia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Planned cesarean
  • Primary cesarean
  • ≥ 38 gestational weeks

Exclusion criteria

  • Previous cesarean
  • Women < 18 years old
  • Multiple gestation
  • Mullerian anomalies
  • Active labor
  • Diabetes
  • BMI >35 kg/m2
  • Placenta praevia
  • Chronic systemic disease
  • Covid-19 infection

Treatment and study plan

Double layer closure of the hysterotomy

Procedure

Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.

Purse closure of the hysterotomy

Procedure

Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium

Primary outcomes

  1. Residual myometrium thickness

    Time frame: 6 months after intervention

Secondary outcomes

  1. Operative time

    Time frame: Same day of intervention: day 1

  2. Estimated blood loss

    Time frame: Same day of intervention: day 1

  3. Mean number of haemostatic sutures

    Time frame: Same day of intervention: day 1

  4. scar width

    Time frame: Same day of intervention: day 1

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Sep 27, 2022

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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