Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Cesarean Section Complications Clinical Trial

Official title:

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766073
• Other study ID #: 8978006-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2021
• Est. completion date: February 2024

Study information

• Verified date: September 2023
• Source: Hadassah Medical Organization
• Contact: Hadas Lemberg, PhD
• Phone: +972 2 6777572
• Email: lhadas[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.

In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women at first cesarean delivery

• Women who consent to the study

Exclusion Criteria:

• Women who are having a repeat caesarean section

• Refusal to participate in the study

• Urgent or emergent cesarean delivery

Related Conditions & MeSH terms

• Cesarean Section Complications
• Surgical Wound
• Uterine Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• Niche prevention suture
This group will have the uterus sutured in two layers using a new technique.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formation of a uterine niche	Presence of a uterine niche on ultrasound	At least 12 weeks after delivery.
Secondary	Duration of surgery	Total duration of surgery	At surgery
Secondary	Blood loss over 1000 mL	As assessed by the operating surgeon	At surgery
Secondary	Postoperative infection	The number of patients who are diagnosed with postoperative infection including endometritis or wound infection.	Up to 6 weeks after intervention
Secondary	Need for repeat laparotomy	The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained.	Up to 6 weeks after intervention
Secondary	Formation of a n abscess/hematoma	The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery.	Up to 6 weeks after intervention