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

NCT05672563 | Unknown

• 1 other identifier: 0298-22-ASF
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.

Conditions

Uterus; Scar

Outcome Measures

Primary Outcomes (1)

• Uterine niche

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

  through study completion, an average of 6 months

Study Arms (1)

women with previous CSP

EXPERIMENTAL

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

Drug: Saline infusion sonography for evaluation of cesarean scar

Interventions

Saline infusion sonography for evaluation of cesarean scar DRUG

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.

Also known as: Saline infusion

women with previous CSP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women with history of cesarean scar pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Related Publications (10)

• 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.

  PMID: 26849801 BACKGROUND

• 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.

  PMID: 29536581 BACKGROUND

• 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.

  PMID: 34196967 BACKGROUND

• 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.

  PMID: 23680518 BACKGROUND

• 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.

  PMID: 31972162 BACKGROUND

• 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.

  PMID: 31677755 BACKGROUND

• 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.

  PMID: 24357257 BACKGROUND

• 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.

  PMID: 33411387 BACKGROUND

• 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.

  PMID: 31788885 BACKGROUND

• 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.

  PMID: 34779085 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yaakov Melcer, Professor

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaakov Melcer, professor

CONTACT

+972-524551310; ymeltcer@gmail.com

Maya Nimrodi, Doctor

CONTACT

+972-524775855; mayadvir1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 5, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 5, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share