Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Cesarean Section; Dehiscence Clinical Trial

Official title:

Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198324
• Other study ID #: KIA 2019/94
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: December 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence
• Cesarean Wound; Dehiscence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brölmann 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean myometrium thickness	Myometrial thickness measured at incision site with transvaginal ultrasonography	6 months after intervention
Secondary	Spotting	The rate of spotting complains of patients	6 months after intervention