Uterine Niche After Cesarean Section

Uterine Scar From Previous Cesarean Delivery (Diagnosis) Clinical Trial

— AMSRM  

Official title:

Factors Influencing the Development of Uterine Niche After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787381
• Other study ID #: 5562-18-SMC
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Disease
• Uterine Scar From Previous Cesarean Delivery (Diagnosis)

Intervention

Device:
• Ultrasound
Vaginal ultrasound examination

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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

Outcome

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