Uterine Niche After Cesarean Section (AMSRM)
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|ClinicalTrials.gov Identifier: NCT03787381|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Uterine Scar From Previous Cesarean Delivery (Diagnosis)||Device: Ultrasound||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Uterine scar will be evaluated by vaginal ultrasound examination
Vaginal ultrasound examination
- 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
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
|Contact: Aya Mohr Sasson, M.Dfirstname.lastname@example.org|
|Sheba Medical Center||Recruiting|
|Ramat Gan, Israel|
|Contact: Aya Mohr Sasson, M.D|
|Principal Investigator:||Aya Mohr Sasson, M.D||Sheba Medical Center, Tel-Hashomer|