Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section
NCT ID: NCT02703519
Last Updated: 2016-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2014-11-30
2016-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1 cesarean section
control group
No interventions assigned to this group
2 cesarean sections
control group
No interventions assigned to this group
resection of uterine scar tissue
2 cesarean sections with resection of uterine scar tissue from first cesarean section
resection of uterine scar tissue
resection of uterine scar tissue of a previous cesarean section during a second cesarean section
Interventions
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resection of uterine scar tissue
resection of uterine scar tissue of a previous cesarean section during a second cesarean section
Eligibility Criteria
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Inclusion Criteria
* primary or secondary indication for cesarean section 6 to 9 months prior to the examination date
Exclusion Criteria
* current pregnancy
* congenital deformity of the uterus
* former surgery of the uterine myometrium
18 Years
FEMALE
No
Sponsors
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Otto-von-Guericke University Magdeburg
OTHER
Martin-Luther-Universität Halle-Wittenberg
OTHER
Responsible Party
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Gregor Seliger
Dr. med., chief resident
Principal Investigators
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Gregor Seliger, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
Michael Tchirikov, Prof.
Role: STUDY_CHAIR
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
Serben-Dan Costa, Prof.
Role: PRINCIPAL_INVESTIGATOR
Maternity Clinic, Magdeburg University Hospital
Locations
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Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
Maternity Clinic, Magdeburg University Hospital
Magdeburg, Saxony-Anhalt, Germany
Countries
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Other Identifiers
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OPSTAR
Identifier Type: -
Identifier Source: org_study_id
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