Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Dehiscence; Cesarean Wound; Dehiscence
• Intervention / Treatment: Procedure: Closure of the uterus with endometrium at the time of cesarean; Procedure: Closure of the uterus without endometrium at the time of cesarean

Detailed Description

Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41380
    • Kocaeli University

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:

• Term pregnancy (≥37 weeks of gestation)
• Singleton pregnancy
• Primary cesarean

Exclusion Criteria:

• Previous cesarean section
• Previous uterine surgery
• Multiple gestations
• Mullerian anomalies
• Active labor
• Placenta previa/accreta

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Entire fold uterine closure; The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium.	Procedure: Closure of the uterus with endometrium at the time of cesarean; Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.
Experimental: Non-endometrial uterine closure; The uterus will be sewn with locked sutures that pass through myometrium without endometrium.	Procedure: Closure of the uterus without endometrium at the time of cesarean; Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with isthmocele six month after cesarean section	Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography	6 months after intervention
Mean myometrium thickness	Myometrial thickness measured at incision site with transvaginal ultrasonography	6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spotting	The rate of spotting complains of patients	6 months after intervention

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Şener Gezer, M.D, Kocaeli University

Publications and helpful links

General Publications

• Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: KIA 2019/94

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