Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar
NCT ID: NCT05672563
Last Updated: 2023-01-05
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-02-01
2023-10-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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women with previous CSP
experimental: women with previous cesarean scar pregnancy that are invited to our unit for sonographic evaluation.
Saline infusion sonography for evaluation of cesarean scar
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.
Interventions
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Saline infusion sonography for evaluation of cesarean scar
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* vaginal bleeding
* active or suspected inflammation of genital tract including pelvic inflammatory disease
* women engaged in unprotected intercourse
* presence of intra-uterine device contraception
18 Years
60 Years
FEMALE
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Yaakov Melcer, Professor
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Central Contacts
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References
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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.
Jordans 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.
Feldman 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.
Tower 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.
Society for Maternal-Fetal Medicine (SMFM). Electronic address: [email protected]; 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.
Timor-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.
Timor-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.
Timor-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.
Cali 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.
Jordans 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.
Other Identifiers
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0298-22-ASF
Identifier Type: -
Identifier Source: org_study_id
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