Clinical trial NCT03930134: Sparse Uterine Closure in Cesarean Section
Official title: Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Scar Defect
Keywords: caesarean
scar defect
sparse uterine suture
one layer uterine suture
blood loss
ultrasound
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This is a secondary analyse of a first randomised trial comparing two caesarean techniques :

* Misgav Ladach with a one layer classic uterine closure.
* French ambulatory Caesarean section with a sparse uterine closure . The first trial is registred under the reference number : NCT03741907. 100 patients with an indication of an elective caesarean section were included in this trial : 50 had a one layer classic uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are enrolled in groupe 2 .
* For the short term results investigators compared : duration of uterine sutures , visually estimated and calculated blood loss
* For the mid term results investigators are shuduling for all partient an hysterosonography 6 mounths after surgery and then will compare : incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
* For the long term results investigators will interview patients 2 years after surgery in order to check for Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy .

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: uterine scar quality
timeFrame: 6 mounth after surgery
Secondary outcomes:
measure: uterine scar thickness
timeFrame: 6 mounth after surgery
measure: duration of surgery
timeFrame: during the caesarean section
measure: calculated blood loss
timeFrame: before and 24 hours after surgery
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Kaouther Dimassi
state: Sidi Daoued La Marsa
Study officials:
References: