Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

NCT04198324 | Completed

• 1 other identifier: KIA 2019/94
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section; Dehiscence; Cesarean Wound; Dehiscence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Spotting

  6 months after intervention

Study Arms (2)

Entire fold uterine closure

ACTIVE COMPARATOR

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

Non-endometrial uterine closure

EXPERIMENTAL

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

Interventions

Closure of the uterus with endometrium at the time of cesarean PROCEDURE

Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.

Entire fold uterine closure

Closure of the uterus without endometrium at the time of cesarean PROCEDURE

Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.

Non-endometrial uterine closure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 23996650 BACKGROUND

Study Officials

• Şener Gezer, M.D

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Closure of the hysterotomy at the time of primary cesarean section

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: December 16, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)