Uterine Closure Techniques and Cesarean Scar Defect Risk

NCT05100147 | Completed

• 1 other identifier: 473
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean operations are one of the most common obsetric operations and have an increasing trend in all over the world. However unfortunately the operation techniques have not been standardized yet. It is well known that different uterine closure techniques result in differences with respect to wound healing on the uterus; however, the ideal uterine closure technique is yet not known. The aim of this study is to assess the results of different uterine closure techniques during cesarean section with respect to the development of cesarean scar defects.

Conditions

Cesarean Section Complications; Scar; Deformity

Keywords

cesarean scar defect; cesarean section; uterine closure techniques

Outcome Measures

Primary Outcomes (2)

• Scar thickness at postpartum 6th week

  The patients will be examined at the postpartum sixth week. During that visit uterine scar thickness will be measured by ultrasound. Measurement of uterine scar thickness will be performed perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.

  Postpartum 6th weeks

• Scar thickness at postpartum 6th month

  The patients will be reexamined at the postpartum sixth month. During that visit uterine scar thickness will be measured again. Measurement of uterine scar thickness will be performed with the same method (perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.)

  Postpartum 6th months

Study Arms (3)

Group 1

EXPERIMENTAL

The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked involving all uterine layers and a second, continuous non-locking imbrictating layer is applied over the first suture.

Procedure: Uterine closure during Cesarean section

Group 2

EXPERIMENTAL

The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked not including decidua and a second, continuous non-locking imbrictating layer is applied over the first suture.

Procedure: Uterine closure during Cesarean section

Group 3

EXPERIMENTAL

The uterotomy suture technique is continous ,double layer with the first layer unlocked, excluding the decidua and including the deep part of the myometrium, and the second layer unlocked including the remaining part of the myometrium.

Procedure: Uterine closure during Cesarean section

Interventions

Uterine closure during Cesarean section PROCEDURE

The uterotomy is sutured after the delivery of the fetus and the placenta with an appropriate delayed absorbable suture (number 1 polyglactin 910)

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• being nulliparous
• having singleton fetus
• not having diabetes and or hypertension
• not having an intrauterine infection
• body mass index \<35 kg/m2
• not having any placental insertion anomalies
• not having Mullerian anomalies
• active phase of labor is not started.
• no previous uterine surgeries

You may not qualify if:

• being multiparous
• having multiple pregnancies
• having diabetes and or hypertension
• having an intrauterine infection
• body mass index \>=35 kg/m2
• having any placental insertion anomalies
• having Mullerian anomalies
• in active phase of labor
• having previous uterine surgeries

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Hospital

Mersin, 33170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cicatrix; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ezgi Oktay, MD

  Mersin University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Hakan Aytan

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 29, 2021
• Study Start: November 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)