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Completed

NCT Number: NCT04198324

Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.

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Key information

Conditions

Cesarean Section; Dehiscence Cesarean Wound; Dehiscence

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Term pregnancy (≥37 weeks of gestation)
  • Singleton pregnancy
  • Primary cesarean

Exclusion criteria

  • Previous cesarean section
  • Previous uterine surgery
  • Multiple gestations
  • Mullerian anomalies
  • Active labor
  • Placenta previa/accreta

Treatment and study plan

Closure of the uterus with endometrium at the time of cesarean

Procedure

Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.

Closure of the uterus without endometrium at the time of cesarean

Procedure

Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.

Primary outcomes

  1. Number of patients with isthmocele six month after cesarean section

    Time frame: 6 months after intervention

    Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography

  2. Mean myometrium thickness

    Time frame: 6 months after intervention

    Myometrial thickness measured at incision site with transvaginal ultrasonography

Secondary outcomes

  1. Spotting

    Time frame: 6 months after intervention

    The rate of spotting complains of patients

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2019
Registry last updated
Dec 16, 2020

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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