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

Study Overview

• Status: Completed
• Conditions: Cesarean Scar Defect
• Intervention / Treatment: Procedure: monofilament

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80129
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: monofilament; monofilament absorbable suture	Procedure: monofilament; In the intervention group,monofilament absorbable suture,will be used.
Active Comparator: polifilament; synthetic absorbable braided (polifilament) suture	Procedure: monofilament; In the intervention group,monofilament absorbable suture,will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of cesarean scar defects at ultrasound 6-months follow-up	6-months follow-up after cesarean

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Saccone G, De Angelis MC, Zizolfi B, Gragnano E, Musone M, Zullo F, Bifulco G, Di Spiezio Sardo A. Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100592. doi: 10.1016/j.ajogmf.2022.100592. Epub 2022 Feb 4.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 25, 2021

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 129/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No