search
Back to results

Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar

Primary Purpose

Uterus; Scar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saline infusion sonography for evaluation of cesarean scar
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterus; Scar

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: women with history of cesarean scar pregnancy Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    women with previous CSP

    Arm Description

    experimental: women with previous cesarean scar pregnancy that are invited to our unit for sonographic evaluation.

    Outcomes

    Primary Outcome Measures

    Uterine niche
    Number of participants who underwent saline infused sonography and have evidence of cesarean scar defects/ uterine niche.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 1, 2023
    Last Updated
    January 4, 2023
    Sponsor
    Assaf-Harofeh Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05672563
    Brief Title
    Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar
    Official Title
    Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assaf-Harofeh Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterus; Scar

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    women with previous CSP
    Arm Type
    Experimental
    Arm Description
    experimental: women with previous cesarean scar pregnancy that are invited to our unit for sonographic evaluation.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline infusion sonography for evaluation of cesarean scar
    Other Intervention Name(s)
    Saline infusion
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Uterine niche
    Description
    Number of participants who underwent saline infused sonography and have evidence of cesarean scar defects/ uterine niche.
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: women with history of cesarean scar pregnancy Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yaakov Melcer, professor
    Phone
    +972-524551310
    Email
    ymeltcer@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maya Nimrodi, Doctor
    Phone
    +972-524775855
    Email
    mayadvir1@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaakov Melcer, Professor
    Organizational Affiliation
    Assaf-Harofeh Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26849801
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29536581
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34196967
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23680518
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31972162
    Citation
    Society 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. Erratum In: Am J Obstet Gynecol. 2020 Oct 6;:
    Results Reference
    background
    PubMed Identifier
    31677755
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24357257
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33411387
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31788885
    Citation
    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. Erratum In: Ultrasound Obstet Gynecol. 2020 Jun;55(6):892.
    Results Reference
    background
    PubMed Identifier
    34779085
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar

    We'll reach out to this number within 24 hrs