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Sparse Uterine Closure in Cesarean Section

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ClinicalTrials.gov Identifier: NCT03930134
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Kaouther Dimassi, University Tunis El Manar

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.

Condition or disease Intervention/treatment Phase
Caesarean Scar Defect Procedure: sparse uterine suture Procedure: one layer uterine closure Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sparse uterine suture
women who had a french ambulatory casarean section including a sparse uterine closure
Procedure: sparse uterine suture
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.

Active Comparator: one layer uterine closure
women who had a misgav ladach caesarean section section, including a one layer classical uterine closure
Procedure: one layer uterine closure
one layer classical continious uterine closure using slowly absorbed Vicryl 1




Primary Outcome Measures :
  1. uterine scar quality [ Time Frame: 6 mounth after surgery ]
    ultrasound visualization of a defect on the internal wall of the uterine scar (niche)


Secondary Outcome Measures :
  1. uterine scar thickness [ Time Frame: 6 mounth after surgery ]
    ultrasound Measured thickness of the scar in sagittal and coronal section.

  2. duration of surgery [ Time Frame: during the caesarean section ]
    time spent for uterine closure

  3. calculated blood loss [ Time Frame: before and 24 hours after surgery ]
    post delivery hematocrit -predelivery hematocrit



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930134


Locations
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Tunisia
Kaouther Dimassi
Tunis, Sidi Daoued La Marsa, Tunisia, 2045
Sponsors and Collaborators
University Tunis El Manar
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Responsible Party: Kaouther Dimassi, associate professor in obstetrics and gynecology, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03930134    
Other Study ID Numbers: sparse uterine closure
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaouther Dimassi, University Tunis El Manar:
caesarean
scar defect
sparse uterine suture
one layer uterine suture
blood loss
ultrasound