Isthmocele After Two Different Sutures in Cesarean Section

Cesarean Scar Defect Clinical Trial

Official title:

Isthmocele After Two Different Sutures in Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073264
• Other study ID #: 129/19
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 25, 2021

Study information

• Verified date: August 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 25, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Scar Defect

Intervention

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

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of cesarean scar defects at ultrasound 6-months follow-up		6-months follow-up after cesarean
Secondary	incidence of scar defects at hysteroscopy at 6 months follow-up		6-months follow-up after cesarean
Secondary	Symptoms of cesarean scar defect	including pain, Abnormal bleeding, Vaginal discharge, Painful periods	6-months follow-up after cesarean
Secondary	RMT	residual myometrial thickness at ultrasound	6-months follow-up after cesarean