- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02827591
Assessing the Stability of Uterine Scar Tissue in Women With Previous History of Caesarean Section Using Multimodal Analyses of the Lower Uterine Segment Including Quantitative Sonography (QUANTUSLUS)
Multimodale Beurteilung Der Stabilität Von Uterusnarbengewebe Bei Z.n. Sectio Caesarea
Study Overview
Status
Conditions
Detailed Description
In 1991, 126.297 (15.3%) women delivered by caesarean section in Germany. Since then, the rate of caesarean section increased steadily over the next 20 years, reaching up to 32.2% in 2011. The absolute risk of uterine rupture in vaginal birth after Caesarean section is 1 in 100 deliveries. The risk of perinatal death or the outcome of extremely neurological impairment is 1 in 1000 deliveries.
Statistically more than 300 pregnant women with a prior caesarean delivery visit daily ultrasound departments of german hospitals to investigate the C-section scar before delivery. They have one important question: Is it possible to predict successful trial of labor after cesarean delivery? The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment.
What are the possibilities of additional parameters to examine the stability of uterine scar tissue? Currently, there is no defined cut-off value of scar thickness for the prediction of uterine rupture. It remains questionable whether the thickness of the lower uterine segment is the determinant factor for the stability of the scar and the probability of rupture. However, another important factor is the functional elasticity or the structure of the connective tissue. It has not been further investigated until now (both quantitatively and qualitatively).
Objective of this project: Multimodalities of assessments, including ultrasonography and elastography, validate the accuracy of uterine scar stability in women with previous history of Caesarean section in vitro and in vivo.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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ST
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Halle (Saale), ST, Germany, 06120
- Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Women with pregnancies after previous cesarean section who referre to the tertiary referral care center.
Pregnant women have been scheduled for a consecutive Caesarean section.
Description
Inclusion Criteria:
- pregnancy after previous cesarean section
- pregnancy between 37 0/7 and 42 0/7 weeks of gestation
- primary or secondary indication for cesarean section
- ability to give informed consent in german or english
Exclusion Criteria:
- emergency caesarean section
- <18 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In vitro Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS
Time Frame: within 1 hour after Cesarean Section
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The measured value of lower uterine segment with quantitative ultrasonic Elastic modulus E (kPA) in vitro versus the experimental tensile property measurements of lower uterine segment done in vitro.
(Spearman's rank correlation coefficient)
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within 1 hour after Cesarean Section
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference - In vivo Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS
Time Frame: within 1 hour after Cesarean Section
|
The measured value of lower uterine segment with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) in vivo versus the experimental tensile property measurements of lower uterine segment done in vitro (postoperatively).
(Spearman's rank correlation coefficient)
|
within 1 hour after Cesarean Section
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gregor Seliger, MD, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
- Study Chair: Michael Tchirikov, MD, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Publications and helpful links
General Publications
- Varner M. Cesarean scar imaging and prediction of subsequent obstetric complications. Clin Obstet Gynecol. 2012 Dec;55(4):988-96. doi: 10.1097/GRF.0b013e318263c699.
- Pollio F, Staibano S, Mascolo M, Salvatore G, Persico F, De Falco M, Di Lieto A. Uterine dehiscence in term pregnant patients with one previous cesarean delivery: growth factor immunoexpression and collagen content in the scarred lower uterine segment. Am J Obstet Gynecol. 2006 Feb;194(2):527-34. doi: 10.1016/j.ajog.2005.07.048.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QUANTUSLUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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