Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uterine Niche After Cesarean Section (AMSRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787381
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Brief Summary:
In the past decade several articles have described a defect that can be seen on ultrasound at the site of cesarean delivery scar, known as a 'niche' .An incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. This study aimes to evaluate the prevalence of niche in a large cohort study after long term follow up since operation, and characterize the risk factors for its development and for symptoms to appear.

Condition or disease Intervention/treatment Phase
Uterine Scar From Previous Cesarean Delivery (Diagnosis) Device: Ultrasound Not Applicable

Detailed Description:

As the rate of cesarean deliveries continues to increase, concern regarding the association between delivery by cesarean section and long‐term maternal morbidity has been growing . In the past decade several articles have described a defect that can be seen on ultrasound at the site of the cesarean delivery scar, known as a 'niche' .A 'niche' describes the presence of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a discontinuation of the myometrium at the site of a previous cesarean delivery . An incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility.

The reported prevalence of a niche in non-pregnant women varies depending on the criteria used to define a niche, the time of evaluation since operation, method of detection, and study population. Osser et al. used the definition 'any visible defect' , Bij de Vaate et al. used 'any indentation of at least 1 mm and van der Voet used a cut‐off level of 2 mm, however, consensus on the exact cut‐off levels is lacking. As approximate evaluation to the operation, the prevalence reported is higher, as early scanning may facilitate the recognition of the location of the caesarean delivery scar in the uterine wall due to incomplete scar healing, with no definition of the most appropriate time since operation. Commonly used methods to evaluate the presence of a niche are trans vaginal ultrasound, sonohysterography and hysteroscopy with detection rate of approximately ~50% of women with previous cesarean section in all methods with no definition of the gold standard.

The aim of this study in to evaluate the prevalence of niche in a large cohort study after long term follow up since operation and characterize the risk factors for its development and for symptoms to appear.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Factors Influencing the Development of Uterine Niche After Cesarean Delivery
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
Uterine scar will be evaluated by vaginal ultrasound examination
Device: Ultrasound
Vaginal ultrasound examination




Primary Outcome Measures :
  1. Diagnosis of uterine niche [ Time Frame: Estimated time of two years ]
    Based on uterine scar measurement -indentation at the site of the cesarean scar with a depth of at least 2 mm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women after cesarean delivery
  • Minimum interval of 3 months since operation

Exclusion Criteria:

  • Uterine scar other than low segment cesarean section ( s/p myomectomy, S/p T scar)
  • Morbidly adherent placenta during pregnancy
  • Cesarean hysterectomy
  • Uterine anomaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787381


Contacts
Layout table for location contacts
Contact: Aya Mohr Sasson, M.D 0523692906 mohraya@gmail.com

Locations
Layout table for location information
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Aya Mohr Sasson, M.D         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Aya Mohr Sasson, M.D Sheba Medical Center, Tel-Hashomer

Publications of Results:

Layout table for additonal information
Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03787381     History of Changes
Other Study ID Numbers: 5562-18-SMC
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
cesarean section, niche, uterine scar defect