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NCT Number: NCT03930134

Sparse Uterine Closure in Cesarean Section

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.

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Key information

Conditions

Caesarean Scar Defect Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaouther Dimassi

Tunis, Sidi Daoued La Marsa, 2045, Tunisia

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

one layer uterine closure

Procedure

one layer classical continious uterine closure using slowly absorbed Vicryl 1

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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