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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Niche, Closure; Incomplete, Uterus

Intervention / Treatment
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* Other: Suture technique


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Previous caesarian delivery Having uterine contraction or cervical dilatation Smoking cigarettes Having systemic or obstetric illnesses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blinded Randomised Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Classical caesarean group<br>Care providers are applying standard caesarean procedure for participants. | |
| Experimental: Study caesarean group<br>Care providers are applying additional sutures to standard caesarean procedure for participants. | Other: Suture technique<br>* We wil apply additional sutures to classical caesarean procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants for each group for study | 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. | Up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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niche, caesarean section, technique, uterine closure