Scar; Previous Cesarean SectionQUANTUSLUSNCT02827591
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
An observational study of Scar; Previous Cesarean Section, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
This prospective, clinical, observational trial compares the measured value with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental measurement done in vitro (postoperatively)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scar; Previous Cesarean Section
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- emergency caesarean section
- <18 years old
Trial locations and contacts
1 site in 1 country.
Germany1 site
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 06120
About this study
Official title: Multimodale Beurteilung Der Stabilität Von Uterusnarbengewebe Bei Z.n. Sectio Caesarea
This prospective, clinical, observational trial compares the measured value with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental measurement done in vitro (postoperatively) of lower uterine segment of women who underwent second cesarean section.
Read the 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.
- Conditions
- Scar; Previous Cesarean Section
- Keywords
- repeat cesarean section, lower uterine segment, quantitative sonography
- Medical subject headings
- Cicatrix
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS
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)
Measured: within 1 hour after Cesarean Section
Secondary outcomes (1)
Difference - In vivo Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS
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)
Measured: within 1 hour after Cesarean Section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scar; Previous Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gregor Seliger, MD, Principal investigator, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-WittenbergMichael Tchirikov, MD, Study chair, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827591
- Sponsor's protocol ID
- QUANTUSLUS
- Acronym
- QUANTUSLUS
- Status last verified
- Jan 2017
- First submitted
- 3 Jul 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23090468Pollio 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.
PubMed 16458657
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodale Beurteilung Der Stabilität Von Uterusnarbengewebe Bei Z.n. Sectio Caesarea
- ClinicalTrials.gov ID
- NCT02827591
- Acronym / sponsor ID
- QUANTUSLUS / QUANTUSLUS
- Conditions
- Scar; Previous Cesarean Section
- Keywords
- repeat cesarean section, lower uterine segment, quantitative sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, clinical, observational trial compares the measured value with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental measurement done in vitro (postoperatively) of lower uterine segment of women who underwent second cesarean section.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- emergency caesarean section
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In vitro 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 Elastic modulus E (kPA) in vitro versus the experimental tensile property measurements of lower uterine segment done in vitro. (Spearman's rank correlation coefficient)
1 secondary outcome
Difference - In vivo Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS
Time frame: within 1 hour after Cesarean Section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Background: PubMed 23090468Varner M. Cesarean scar imaging and prediction of subsequent obstetric complications. Clin Obstet Gynecol. 2012 Dec;55(4):988-96. doi: 10.1097/GRF.0b013e318263c699.
- Background: PubMed 16458657Pollio 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.
- CitationsLink provided by the sponsor.
- CitationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Seliger, MD principal investigator
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Michael Tchirikov, MD study chair
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scar; Previous Cesarean Section, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS (time frame: within 1 hour after Cesarean Section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.