Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section
OPSTAR
Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea
1 other identifier
interventional
116
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 9, 2016
September 1, 2016
1.8 years
March 6, 2016
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of uterine Cesarean section scars using transvaginal ultrasound
6-9 months
Secondary Outcomes (1)
median myometrial thickness of lower uterine segment using transvaginal ultrasound
6-9months
Study Arms (3)
1 cesarean section
NO INTERVENTIONcontrol group
2 cesarean sections
NO INTERVENTIONcontrol group
resection of uterine scar tissue
EXPERIMENTAL2 cesarean sections with resection of uterine scar tissue from first cesarean section
Interventions
resection of uterine scar tissue of a previous cesarean section during a second cesarean section
Eligibility Criteria
You may qualify if:
- years or older
- primary or secondary indication for cesarean section 6 to 9 months prior to the examination date
You may not qualify if:
- \<18 years old
- current pregnancy
- congenital deformity of the uterus
- former surgery of the uterine myometrium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregor Seliger, Dr. med.
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
- STUDY CHAIR
Michael Tchirikov, Prof.
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
- PRINCIPAL INVESTIGATOR
Serben-Dan Costa, Prof.
Maternity Clinic, Magdeburg University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med., chief resident
Study Record Dates
First Submitted
March 6, 2016
First Posted
March 9, 2016
Study Start
November 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 9, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share