Sparse Uterine Closure in Cesarean Section

NCT03930134 | Completed

• 1 other identifier: sparse uterine closure
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The existence and the characteristics of a wedge- shaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors. Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar. Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications are likely to be associated with poor uterine scar healing following cesarean sections. Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section. Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity. For this reason, investigators designed this prospective clinical study to analyze the effects of two different uterine suturing techniques. their aim was to compare the sparse closure of the uterine incision to classical one layer closure regarding short , mid and long term results. In deed, they compared :

• duration of surgery and calculated blood loss during surgery as short term results - incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
• Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of these patients as long-term results.

Conditions

Caesarean Scar Defect

Keywords

caesarean; scar defect; sparse uterine suture; one layer uterine suture; blood loss; ultrasound

Outcome Measures

Primary Outcomes (1)

• uterine scar quality

  ultrasound visualization of a defect on the internal wall of the uterine scar (niche)

  6 mounth after surgery

Secondary Outcomes (3)

• uterine scar thickness

  6 mounth after surgery

• duration of surgery

  during the caesarean section

• calculated blood loss

  before and 24 hours after surgery

Study Arms (2)

sparse uterine suture

EXPERIMENTAL

women who had a french ambulatory casarean section including a sparse uterine closure

Procedure: sparse uterine suture

one layer uterine closure

ACTIVE COMPARATOR

women who had a misgav ladach caesarean section section, including a one layer classical uterine closure

Procedure: one layer uterine closure

Interventions

sparse uterine suture PROCEDURE

The slowly absorbed Vicryl 1 suture with a large round needle is introduced intramyometrially right above the endometrium. The suture starts in one corner and proceeds along the lower then the upper edge returning back to the incision point. Subserous layer is closed upon using the same thread in order to cover the purse suture and to complete the haemostasis while increasing the wound thickness.

sparse uterine suture

one layer uterine closure PROCEDURE

one layer classical continious uterine closure using slowly absorbed Vicryl 1

one layer uterine closure

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancy
• Cicatricial uterus with contraindication to vaginal delivery (uterus bi or multi-cicatricial, corporal uterine scar, intra-mural myomectomy, dystocic presentation)
• Fetal macrosomia with a weight greater than 4Kg
• Placenta previa

You may not qualify if:

• Patients who refuse to participate in the study
• prenatally diagnosed fetal pathology (intrauterine growth restriction, malformation, genetics disorders)
• adherent placenta, an adnexal mass or a myoma at the lower uterine segment
• Cesarean section in a context of medical or obstetrical emergency
• Caesarean section with a high risk of bleeding

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Kaouther Dimassi

Tunis, Sidi Daoued La Marsa, 2045, Tunisia

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: associate professor in obstetrics and gynecology

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 29, 2019
• Study Start: February 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 2, 2020
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)