Uterus; ScarNCT05672563
Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar
A study testing Saline infusion sonography for evaluation of cesarean scar in people with Uterus; Scar, run by Assaf-Harofeh Medical Center.
Trial summary
Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Uterus; Scar
- What is being tested?
- Saline infusion sonography for evaluation of cesarean scar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Oct 2023
- Phase
- Interventional
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with history of cesarean scar pregnancy
Who cannot join
- ongoing pregnancy
- vaginal bleeding
- active or suspected inflammation of genital tract including pelvic inflammatory disease
- women engaged in unprotected intercourse
- presence of intra-uterine device contraception
Trial locations and contacts
No sites are listed yet.
About this study
Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.
Read the detailed description
Over the past few decades, cesarean delivery rates worldwide have risen considerably. The surgery may lead to deficient uterine scar healing, thinning of the myometrium and formation of cesarean scar defects or uterine scar niche. The prevalence of clinically relevant cesarean scar defects is unclear and has been reported between 20-88%, it is identified by using transvaginal ultrasound or saline-infused sonography in non-pregnant patients. Women may be asymptomatic or present a wide gynecologic sequela including cesarean scar pregnancy, abnormal uterine bleeding, dysmenorrhea, chronic pelvic pain, infertility, and increased risk of complications during gynecologic procedures such as uterine evacuation and insertion of intrauterine device.
Cesarean scar pregnancy (CSP) is defined as an early pregnancy implantation in the scar from a prior cesarean delivery. This pregnancy is implanted in a fibrous scar tissue and may lead to substantial risk for severe maternal morbidity such as adherent placenta, second or third trimester uterine dehiscence or rupture, severe maternal bleeding, and adherence to adjacent tissues. The prevalence of scar pregnancy is reported to be between 1:1800-2500 pregnancies, with increasing diagnosis in the last decade due to increasing use of transvaginal ultrasound early in pregnancy and possible increased physician awareness of this condition.
The ultrasound criteria for CSP have been redefined recently, and now propose transvaginal ultrasound as the imaging technique of choice at this early stage. In 2022, the Niche Task-force convened a Delphi consensus to develop a standardized sonographic evaluation and reporting system for a CSP in the first trimester. According to this consensus, CSPs were classified into three subgroups, Subgroup A in which the largest part of the gestational sac protruded towards the uterine cavity, subgroup B in which the largest part of the gestational sac was embedded in the myometrium, and subgroup C in which the gestational was partially located outside the outer contour of the cervix or uterus. This sonographic classification has yet to be validated clinically.
In the present report the investigators aim to evaluate the uterine cavity and potential cesarean scar defects or niche in women with history of CSP using saline infused sonography. In the second stage of the research, we will classify the past cesarean pregnancies according to the new Delphi criteria and examine correlation between the different CSP subgroups and presence of cesarean scar defects.
- Conditions
- Uterus; Scar
- Being tested
- Saline infusion sonography for evaluation of cesarean scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline infusion sonography for evaluation of cesarean scarDrug
Also called Saline infusion
The intervention included the usage of balloon-less GIS catheter with a soft tapered tip inserted into the endocervical canal, with no use of a tenaculum or a cervical dilatator. Normal saline is slowly introduced into the uterine cavity via the catheter until achieving satisfactory distension and visualization of the uterine cavity using trans-vaginal ultra-sonographic imaging.
| Study group | Role | What they receive |
|---|---|---|
| women with previous CSP | Experimental | experimental: women with previous cesarean scar pregnancy that are invited to our unit for sonographic evaluation. Receives: Drug: Saline infusion sonography for evaluation of cesarean scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine niche
Number of participants who underwent saline infused sonography and have evidence of cesarean scar defects/ uterine niche.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Uterus; ScarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study in a tertiary referral center. Investigators evaluated the procedure on a group of 40 participants that are invited to our unit for evaluation of cesarean scar by using a saline-infused sonography examination. Secondly, the medical records of all identified cases are retrospectively reviewed and the CSPs are classified into three subgroups according to the level of CSP sac herniation proposed by the Delphi criteria.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yaakov Melcer, Professor, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672563
- Sponsor's protocol ID
- 0298-22-ASF
- Status last verified
- Dec 2022
- First submitted
- 1 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
PubMed 29536581Feldman N, Maymon R, Jauniaux E, Manoach D, Mor M, Marczak E, Melcer Y. Prospective Evaluation of the Ultrasound Signs Proposed for the Description of Uterine Niche in Nonpregnant Women. J Ultrasound Med. 2022 Apr;41(4):917-923. doi: 10.1002/jum.15776. Epub 2021 Jul 1.
PubMed 34196967Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
PubMed 23680518Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Miller R, Timor-Tritsch IE, Gyamfi-Bannerman C. Society for Maternal-Fetal Medicine (SMFM) Consult Series #49: Cesarean scar pregnancy. Am J Obstet Gynecol. 2020 May;222(5):B2-B14. doi: 10.1016/j.ajog.2020.01.030. Epub 2020 Jan 21.
PubMed 31972162Timor-Tritsch IE, Monteagudo A, Cali G, D'Antonio F, Kaelin Agten A. Cesarean Scar Pregnancy: Diagnosis and Pathogenesis. Obstet Gynecol Clin North Am. 2019 Dec;46(4):797-811. doi: 10.1016/j.ogc.2019.07.009.
PubMed 31677755Timor-Tritsch IE, Monteagudo A, Cali G, Palacios-Jaraquemada JM, Maymon R, Arslan AA, Patil N, Popiolek D, Mittal KR. Cesarean scar pregnancy and early placenta accreta share common histology. Ultrasound Obstet Gynecol. 2014 Apr;43(4):383-95. doi: 10.1002/uog.13282.
PubMed 24357257Timor-Tritsch IE, Horwitz G, D'Antonio F, Monteagudo A, Bornstein E, Chervenak J, Messina L, Morlando M, Cali G. Recurrent Cesarean scar pregnancy: case series and literature review. Ultrasound Obstet Gynecol. 2021 Jul;58(1):121-126. doi: 10.1002/uog.23577.
PubMed 33411387Cali G, Timor-Tritsch IE, Forlani F, Palacios-Jaraquemada J, Monteagudo A, Kaelin Agten A, Flacco ME, Khalil A, Buca D, Manzoli L, Liberati M, D'Antonio F. Value of first-trimester ultrasound in prediction of third-trimester sonographic stage of placenta accreta spectrum disorder and surgical outcome. Ultrasound Obstet Gynecol. 2020 Apr;55(4):450-459. doi: 10.1002/uog.21939.
PubMed 31788885Jordans IPM, Verberkt C, De Leeuw RA, Bilardo CM, Van Den Bosch T, Bourne T, Brolmann HAM, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Kaelin Agten A, Mashiach R, Naji O, Pajkrt E, Timmerman D, Vikhareva O, Van Der Voet LF, Huirne JAF. Definition and sonographic reporting system for Cesarean scar pregnancy in early gestation: modified Delphi method. Ultrasound Obstet Gynecol. 2022 Apr;59(4):437-449. doi: 10.1002/uog.24815.
PubMed 34779085
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar
- ClinicalTrials.gov ID
- NCT05672563
- Acronym / sponsor ID
- 0298-22-ASF
- Conditions
- Uterus; Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 5 Jan 2023 (actual)
- 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.
Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.
Detailed description
Over the past few decades, cesarean delivery rates worldwide have risen considerably. The surgery may lead to deficient uterine scar healing, thinning of the myometrium and formation of cesarean scar defects or uterine scar niche. The prevalence of clinically relevant cesarean scar defects is unclear and has been reported between 20-88%, it is identified by using transvaginal ultrasound or saline-infused sonography in non-pregnant patients. Women may be asymptomatic or present a wide gynecologic sequela including cesarean scar pregnancy, abnormal uterine bleeding, dysmenorrhea, chronic pelvic pain, infertility, and increased risk of complications during gynecologic procedures such as uterine evacuation and insertion of intrauterine device.
Cesarean scar pregnancy (CSP) is defined as an early pregnancy implantation in the scar from a prior cesarean delivery. This pregnancy is implanted in a fibrous scar tissue and may lead to substantial risk for severe maternal morbidity such as adherent placenta, second or third trimester uterine dehiscence or rupture, severe maternal bleeding, and adherence to adjacent tissues. The prevalence of scar pregnancy is reported to be between 1:1800-2500 pregnancies, with increasing diagnosis in the last decade due to increasing use of transvaginal ultrasound early in pregnancy and possible increased physician awareness of this condition.
The ultrasound criteria for CSP have been redefined recently, and now propose transvaginal ultrasound as the imaging technique of choice at this early stage. In 2022, the Niche Task-force convened a Delphi consensus to develop a standardized sonographic evaluation and reporting system for a CSP in the first trimester. According to this consensus, CSPs were classified into three subgroups, Subgroup A in which the largest part of the gestational sac protruded towards the uterine cavity, subgroup B in which the largest part of the gestational sac was embedded in the myometrium, and subgroup C in which the gestational was partially located outside the outer contour of the cervix or uterus. This sonographic classification has yet to be validated clinically.
In the present report the investigators aim to evaluate the uterine cavity and potential cesarean scar defects or niche in women with history of CSP using saline infused sonography. In the second stage of the research, we will classify the past cesarean pregnancies according to the new Delphi criteria and examine correlation between the different CSP subgroups and presence of cesarean scar defects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study in a tertiary referral center. Investigators evaluated the procedure on a group of 40 participants that are invited to our unit for evaluation of cesarean scar by using a saline-infused sonography examination. Secondly, the medical records of all identified cases are retrospectively reviewed and the CSPs are classified into three subgroups according to the level of CSP sac herniation proposed by the Delphi criteria.
| Arm | Type | Receives |
|---|---|---|
| women with previous CSP | Experimental | Drug: Saline infusion sonography for evaluation of cesarean scarexperimental: women with previous cesarean scar pregnancy that are invited to our unit for sonographic evaluation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with history of cesarean scar pregnancy
Key exclusion criteria (5 listed)
- ongoing pregnancy
- vaginal bleeding
- active or suspected inflammation of genital tract including pelvic inflammatory disease
- women engaged in unprotected intercourse
- presence of intra-uterine device contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline infusion sonography for evaluation of cesarean scarAlso: Saline infusionThe intervention included the usage of balloon-less GIS catheter with a soft tapered tip inserted into the endocervical canal, with no use of a tenaculum or a cervical dilatator. Normal saline is slowly introduced into the uterine cavity via the catheter until achieving satisfactory distension and visualization of the uterine cavity using trans-vaginal ultra-sonographic imaging. | Drug | women with previous CSP |
Primary outcome
Uterine niche
Time frame: through study completion, an average of 6 months
Number of participants who underwent saline infused sonography and have evidence of cesarean scar defects/ uterine niche.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Background: PubMed 29536581Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
- Background: PubMed 34196967Feldman N, Maymon R, Jauniaux E, Manoach D, Mor M, Marczak E, Melcer Y. Prospective Evaluation of the Ultrasound Signs Proposed for the Description of Uterine Niche in Nonpregnant Women. J Ultrasound Med. 2022 Apr;41(4):917-923. doi: 10.1002/jum.15776. Epub 2021 Jul 1.
- Background: PubMed 23680518Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
- Background: PubMed 31972162Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Miller R, Timor-Tritsch IE, Gyamfi-Bannerman C. Society for Maternal-Fetal Medicine (SMFM) Consult Series #49: Cesarean scar pregnancy. Am J Obstet Gynecol. 2020 May;222(5):B2-B14. doi: 10.1016/j.ajog.2020.01.030. Epub 2020 Jan 21.
- Background: PubMed 31677755Timor-Tritsch IE, Monteagudo A, Cali G, D'Antonio F, Kaelin Agten A. Cesarean Scar Pregnancy: Diagnosis and Pathogenesis. Obstet Gynecol Clin North Am. 2019 Dec;46(4):797-811. doi: 10.1016/j.ogc.2019.07.009.
- Background: PubMed 24357257Timor-Tritsch IE, Monteagudo A, Cali G, Palacios-Jaraquemada JM, Maymon R, Arslan AA, Patil N, Popiolek D, Mittal KR. Cesarean scar pregnancy and early placenta accreta share common histology. Ultrasound Obstet Gynecol. 2014 Apr;43(4):383-95. doi: 10.1002/uog.13282.
- Background: PubMed 33411387Timor-Tritsch IE, Horwitz G, D'Antonio F, Monteagudo A, Bornstein E, Chervenak J, Messina L, Morlando M, Cali G. Recurrent Cesarean scar pregnancy: case series and literature review. Ultrasound Obstet Gynecol. 2021 Jul;58(1):121-126. doi: 10.1002/uog.23577.
- Background: PubMed 31788885Cali G, Timor-Tritsch IE, Forlani F, Palacios-Jaraquemada J, Monteagudo A, Kaelin Agten A, Flacco ME, Khalil A, Buca D, Manzoli L, Liberati M, D'Antonio F. Value of first-trimester ultrasound in prediction of third-trimester sonographic stage of placenta accreta spectrum disorder and surgical outcome. Ultrasound Obstet Gynecol. 2020 Apr;55(4):450-459. doi: 10.1002/uog.21939.
- Background: PubMed 34779085Jordans IPM, Verberkt C, De Leeuw RA, Bilardo CM, Van Den Bosch T, Bourne T, Brolmann HAM, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Kaelin Agten A, Mashiach R, Naji O, Pajkrt E, Timmerman D, Vikhareva O, Van Der Voet LF, Huirne JAF. Definition and sonographic reporting system for Cesarean scar pregnancy in early gestation: modified Delphi method. Ultrasound Obstet Gynecol. 2022 Apr;59(4):437-449. doi: 10.1002/uog.24815.
- 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.
Yaakov Melcer, Professor principal investigator
Assaf-Harofeh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Saline infusion sonography for evaluation of cesarean scar in people with Uterus; Scar, run by Assaf-Harofeh Medical Center.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaakov Melcer, professor (+972-524551310, ymeltcer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine niche (time frame: through study completion, an average of 6 months). 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 NCT05672563, which also lists 10 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 2023.