NCT03930134

Sparse Uterine Closure in Cesarean Section

Completed NA Last updated 10 January 2020

What this trial tests

NA trial testing sparse uterine suture in Caesarean Scar Defect in 100 participants. Completed in 2 January 2020.

Timeline

1 February 2019

Primary endpoint
30 December 2019

2 January 2020

Quick facts

Lead sponsor	University Tunis El Manar
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	100
Start date	1 February 2019
Primary completion	30 December 2019
Estimated completion	2 January 2020
Sites	1 location across Tunisia

Drugs / interventions tested

• sparse uterine suture
• one layer uterine closure

Conditions studied

• Caesarean Scar Defect — all drugs for Caesarean Scar Defect →

Sponsor

University Tunis El Manar

Who can join

Adults 18 to 44, female only, with Caesarean Scar Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The extraperitoneal French AmbUlatory cesarean section technique leads to improved pain scores and a faster maternal autonomy compared with the intraperitoneal Misgav Ladach technique: A prospective randomized controlled trial.
   Dimassi K, Halouani A, Kammoun A, Ami O, et al · · 2021 · cited 11× · PMID 33481875 · DOI 10.1371/journal.pone.0245645
2. Double-layered purse string uterine suture employing the French ambulatory cesarean section technique compared with single-layer continuous uterine suture: An ultrasound evaluation randomized trial.
   dimassi k, ami o, merrai r, velemir l, et al · · 2021 · DOI 10.22541/au.161400220.01270649/v1