Isthmocele After Two Different Sutures in Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Scar Defect

• Registration Number: NCT04073264
• Lead Sponsor: Federico II University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Study Start: 2019-09-01
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
incidence of cesarean scar defects at ultrasound 6-months follow-up	6-months follow-up after cesarean

Secondary Outcome Measures

Name	Time	Method
Symptoms of cesarean scar defect	6-months follow-up after cesarean	including pain, Abnormal bleeding, Vaginal discharge, Painful periods
RMT	6-months follow-up after cesarean	residual myometrial thickness at ultrasound
incidence of scar defects at hysteroscopy at 6 months follow-up	6-months follow-up after cesarean

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Napoli, Italy