Uterine Scar From Previous Cesarean Delivery (Diagnosis) Clinical Trial
— AMSRMOfficial title:
Factors Influencing the Development of Uterine Niche After Cesarean Delivery
Verified date | June 2022 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 282 |
Est. completion date | June 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brölmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasoun — View Citation
Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496. — View Citation
Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829 — View Citation
van der Voet LF, Bij de Vaate AM, Veersema S, Brölmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2): — View Citation
Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brölmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Se — View Citation
Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009 Jul;34(1):85-9. doi: 10.1002/uog.6405. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of uterine niche | Based on uterine scar measurement -indentation at the site of the cesarean scar with a depth of at least 2 mm | Estimated time of two years |