Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 116
- Locations
- 3
- Primary Endpoint
- number of uterine Cesarean section scars using transvaginal ultrasound
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
number of uterine Cesarean section scars using transvaginal ultrasound
Time Frame: 6-9 months
Secondary Outcomes
- median myometrial thickness of lower uterine segment using transvaginal ultrasound(6-9months)
Investigators
Gregor Seliger
Dr. med., chief resident
Martin-Luther-Universität Halle-Wittenberg