Clinical Trials Directory

Trials / Completed

CompletedNCT04073264

Isthmocele After Two Different Sutures in Cesarean Section

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
300 (actual)
Sponsor
Federico II University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREmonofilamentIn the intervention group,monofilament absorbable suture,will be used.

Timeline

Start date
2019-09-01
Primary completion
2021-07-20
Completion
2021-07-25
First posted
2019-08-29
Last updated
2021-08-24

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04073264. Inclusion in this directory is not an endorsement.