Isthmocele After Two Different Sutures in Cesarean Section

Study Overview
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Brief Summary
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Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a isthmocele, defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT. A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another. The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean

Official Title
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Isthmocele After Two Different Sutures in Cesarean Section

Conditions
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Cesarean Scar Defect

Intervention / Treatment
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* Procedure: monofilament


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with singleton gestations Between ≥37 and ≤42 gestational age >18 <45 years Undergoing primary or secondary elective or urgent cesarean delivery Exclusion Criteria: Multiple gestations Preterm cesarean 2 or more prior cesarean deliveries Uterine malformations Prior myomectomy Placenta accreta/previa

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monofilament<br>monofilament absorbable suture | Procedure: monofilament<br>* In the intervention group,monofilament absorbable suture,will be used.<br>|
| Active Comparator: polifilament<br>synthetic absorbable braided (polifilament) suture | Procedure: monofilament<br>* In the intervention group,monofilament absorbable suture,will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cesarean scar defects at ultrasound 6-months follow-up |  | 6-months follow-up after cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of scar defects at hysteroscopy at 6 months follow-up |  | 6-months follow-up after cesarean | 
| Symptoms of cesarean scar defect | including pain, Abnormal bleeding, Vaginal discharge, Painful periods | 6-months follow-up after cesarean | 
| RMT | residual myometrial thickness at ultrasound | 6-months follow-up after cesarean |