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
About this trial
This is an interventional diagnostic trial for Uterus; Scar
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
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
NCT ID
NCT05672563
First Posted
January 1, 2023
Last Updated
January 4, 2023
Sponsor
Assaf-Harofeh Medical Center
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
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Results Reference
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PubMed Identifier
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Citation
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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
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Citation
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Results Reference
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PubMed Identifier
31972162
Citation
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Citation
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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.
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Citation
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Citation
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Results Reference
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Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar
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