Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section

Study Overview
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Brief Summary
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This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound. It is the purpose of the study to assess if a resection of the uterine scar from a previous Cesarean section during a second Cesarean section could lead to a decrease in risk for subsequent pregnancies.

Detailed Description
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The average number of Cesarean sections in Germany has doubled from 1991 to 2011, making up 32,1% of all deliveries in 2011. Several studies describe instances in which pregnancies following a previous Cesarean section were accompanied by complications such as life-threatening bleeding, placenta previa, placenta accreta, increta or percreta and dehiscence or uterine rupture. The risk of those complications increases further with the uterine scar tissue of a second Cesarean section. Today it is already common practice to resect uterine scars if the scar of a previous Cesarean section becomes symptomatic, or when a non-symptomatic uterine rupture or serious dehiscence are discovered during a Cesarean delivery. In this study all participants of the interventional group are examined via intraoperative ultrasound to identify the first uterine Cesarean section scar and resect it completely. Six to nine months after the resection participants will return for a one time follow-up. At this time, the investigators will measure the number of uterine scars and median myometrial thickness using transvaginal ultrasound. The results will be compared with those of two control groups, consisting of women who underwent either one or two Cesarean sections without the intervention. The aim of the present study is to asses if the number of uterine scars and median myometrial thickness can be improved by the resection of the first uterine scar during a subsequent Cesarean section. This will allow the investigators to draw conclusions regarding the benefit of routine resections of uterine Cesarean section scars, and whether this practice could lead to a decreased risk for women undergoing two or more Cesarean sections.

Official Title
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Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea

Conditions
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Scar; Previous Cesarean Section, Complications; Cesarean Section, Wound, Dehiscence

Intervention / Treatment
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* Procedure: resection of uterine scar tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older primary or secondary indication for cesarean section 6 to 9 months prior to the examination date Exclusion Criteria: <18 years old current pregnancy congenital deformity of the uterus former surgery of the uterine myometrium

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1 cesarean section<br>control group | |
| No Intervention: 2 cesarean sections<br>control group | |
| Experimental: resection of uterine scar tissue<br>2 cesarean sections with resection of uterine scar tissue from first cesarean section | Procedure: resection of uterine scar tissue<br>* resection of uterine scar tissue of a previous cesarean section during a second cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of uterine Cesarean section scars using transvaginal ultrasound |  | 6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median myometrial thickness of lower uterine segment using transvaginal ultrasound |  | 6-9months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, repeat, uterine scar tissue, transvaginal ultrasound, uterine rupture, placenta accreta, placenta percreta, placenta increta