Scar; Previous Cesarean SectionSALUTARYNCT02827604
Preoperative and Intraoperative Sonographic Assessment of Lower Uterine Segment Thickness at Term in Women With Previous Cesarean Delivery - a Ultrasound Method Comparison Study
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 study compares preoperative and intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section. 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.
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: Präoperative Und Intraoperative Sonografische Beurteilung Des Unteren Uterinsegmentes im Rahmen Der Re-Sectio Caesarea - Eine Ultraschall- Methoden-Vergleichsstudie
This prospective, clinical, observational study compares preoperative and intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.
It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.
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 [https://www.destatis.de]. 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 [Cunningham et al., 2009].
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? [AQUA-Institut] The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment [Varner et al., 2012].
The measurement technique for lower uterine segment (myometrial) thicknesses in the third trimester have been described by several authors. Using a combination of preoperative transvaginal and transabdominal (linear/convex probe) ultrasound, we compare with intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.
The aim of the present study is to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.
This will allow the investigators to draw conclusions regarding the best method to assessment of lower uterine segment (myometrial) thickness in the third trimester to predict successful trial of labor after cesarean delivery.
- Conditions
- Scar; Previous Cesarean Section
- Keywords
- Caesarean section, lower uterine segment, sonography
- Medical subject headings
- Cicatrix
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I
Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transabdominal (linear ultrasound probe) and with transvaginal sonography (vaginal ultrasound probe) with the lowest value (thinnest area) being retained AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)
Measured: intraoperative - just bevore the uterotomy
Secondary outcomes (3)
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA
Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transabdominal (linear ultrasound probe) AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)
Measured: intraoperative - just bevore the uterotomy
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB
Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transabdominal (convex ultrasound probe) AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)
Measured: intraoperative - just bevore the uterotomy
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC
Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transvaginal sonography (vaginal ultrasound probe) AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)
Measured: intraoperative - just bevore the uterotomy
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 (1)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
- NCT02827604
- Sponsor's protocol ID
- SALUTARY
- Acronym
- SALUTARY
- Status last verified
- Jan 2017
- First submitted
- 2 Jul 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Seliger G, Chaoui K, Lautenschlager C, Riemer M, Tchirikov M. Technique of sonographic assessment of lower uterine segment in women with previous cesarean delivery: a prospective, pre/intraoperative comparative ultrasound study. Arch Gynecol Obstet. 2018 Aug;298(2):297-306. doi: 10.1007/s00404-018-4805-6. Epub 2018 Jun 8.
PubMed 29948165
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
- Präoperative Und Intraoperative Sonografische Beurteilung Des Unteren Uterinsegmentes im Rahmen Der Re-Sectio Caesarea - Eine Ultraschall- Methoden-Vergleichsstudie
- ClinicalTrials.gov ID
- NCT02827604
- Acronym / sponsor ID
- SALUTARY / SALUTARY
- Conditions
- Scar; Previous Cesarean Section
- Keywords
- Caesarean section, lower uterine segment, 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 study compares preoperative and intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.
It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.
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 [https://www.destatis.de]. 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 [Cunningham et al., 2009].
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? [AQUA-Institut] The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment [Varner et al., 2012].
The measurement technique for lower uterine segment (myometrial) thicknesses in the third trimester have been described by several authors. Using a combination of preoperative transvaginal and transabdominal (linear/convex probe) ultrasound, we compare with intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.
The aim of the present study is to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.
This will allow the investigators to draw conclusions regarding the best method to assessment of lower uterine segment (myometrial) thickness in the third trimester to predict successful trial of labor after cesarean delivery.
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.
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
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I
Time frame: intraoperative - just bevore the uterotomy
Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transabdominal (linear ultrasound probe) and with transvaginal sonography (vaginal ultrasound probe) with the lowest value (thinnest area) being retained AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)
3 secondary outcomes
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA
Time frame: intraoperative - just bevore the uterotomy
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB
Time frame: intraoperative - just bevore the uterotomy
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC
Time frame: intraoperative - just bevore the uterotomy
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.
- Derived from this study: PubMed 29948165Seliger G, Chaoui K, Lautenschlager C, Riemer M, Tchirikov M. Technique of sonographic assessment of lower uterine segment in women with previous cesarean delivery: a prospective, pre/intraoperative comparative ultrasound study. Arch Gynecol Obstet. 2018 Aug;298(2):297-306. doi: 10.1007/s00404-018-4805-6. Epub 2018 Jun 8.
- Individual participant dataSharing planned: No
Related trials for Scar; Previous Cesarean Section
Active, not recruiting
Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
Thinned-out Lower Uterine Segment Scar Previous Cesarean Section
RecruitingObservational study
Relation Between Type of Scar Pregnancy and Number of Previous Cesarean Sections
Scar Pregnancy
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?
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I (time frame: intraoperative - just bevore the uterotomy). 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 NCT02827604, which also lists 1 linked publication.
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.