Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.

Not Applicable

• Conditions: Closure; Incomplete, Uterus; Uterine Niche
• Interventions: Other: Suture technique

• Registration Number: NCT04799457
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

Caesarean section scar may have result as isthmocele or scar detachment during pregnancy which is in few years after previous delivery. Uterine niche is the most effectively used measurement side of uterus to estimate for these detachment complications. The aim of this study is to support this niche site by supporting the classical uterine closure technique.

Detailed Description

Cesarean delivery rate continues to increase in world in concern with uterine scar complications as placental invasion abnormalities, isthmocele or previous scar detachment during pregnancy (post surgical long term complications). Uterine niche is the presence of a hypoechoic area within the myometrium on the lower uterine segment, showing a defect of the myometrium at the site of a previous cesarean delivery. Some surgical techniques have been trying to support this area to prevent the post surgical long term complications. In this study the investigators have been trying to find out a new technique by applying supporting sutures during uterine closure in cesarean section. Three months after the surgery, the uterine niche measurement will be examined with ultrasonography for both study and classical groups and results will be compared between the groups.

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Primary Completion: 2021-07-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Primigravid elective caesarian delivery candidates
• The participants will have not any uterine contraction or cervical dilatation before delivery.
• Having no systemic or obstetric illnesses
• Participants who are accept to participate in this study with their written consent.

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Exclusion Criteria

• Previous caesarian delivery
• Having uterine contraction or cervical dilatation
• Smoking cigarettes
• Having systemic or obstetric illnesses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study caesarean group	Suture technique	Care providers are applying additional sutures to standard caesarean procedure for participants.

Primary Outcome Measures

Name	Time	Method
Number of participants for each group for study	Up to 9 months	We will try to reach fifty participants for each group (study group as classical cesarean with supporting suture and control group as classical cesarean) . When we reach to all participants we will stop to enroll the participants.

Trial Locations

Locations (1)

Prof Dr Suleyman Yalcin Goztepe City Hospital; 🇹🇷 Istanbul, Kadikoy, Turkey