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

January 4, 2023 updated by: Assaf-Harofeh Medical Center
Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: women with previous CSP
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
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 Names:
  • Saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Yaakov Melcer, Professor, Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0298-22-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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