Skip to main content
OpenTrials
Completed

NCT Number: NCT04073264

Isthmocele After Two Different Sutures in Cesarean Section

Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT.

A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another.

The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gabriele Saccone

Naples, 80129, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women with singleton gestations
  • Between ≥37 and ≤42 gestational age
  • >18 <45 years
  • Undergoing primary or secondary elective or urgent cesarean delivery

Exclusion criteria

  • Multiple gestations
  • Preterm cesarean
  • 2 or more prior cesarean deliveries
  • Uterine malformations
  • Prior myomectomy
  • Placenta accreta/previa

Treatment and study plan

monofilament

Procedure

In the intervention group,monofilament absorbable suture,will be used.

Primary outcomes

  1. incidence of cesarean scar defects at ultrasound 6-months follow-up

    Time frame: 6-months follow-up after cesarean

Secondary outcomes

  1. incidence of scar defects at hysteroscopy at 6 months follow-up

    Time frame: 6-months follow-up after cesarean

  2. Symptoms of cesarean scar defect

    Time frame: 6-months follow-up after cesarean

    including pain, Abnormal bleeding, Vaginal discharge, Painful periods

  3. RMT

    Time frame: 6-months follow-up after cesarean

    residual myometrial thickness at ultrasound

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2019
Registry last updated
Aug 24, 2021

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.

Published trials that share one or more normalized conditions with this study.