NCT03787381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

3.4 years

First QC Date

December 19, 2018

Last Update Submit

June 23, 2022

Conditions

Uterine Scar From Previous Cesarean Delivery (Diagnosis)

Keywords

cesarean section, niche, uterine scar defect

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intervention

OTHER

Uterine scar will be evaluated by vaginal ultrasound examination

Device: Ultrasound

Interventions

UltrasoundDEVICE

Vaginal ultrasound examination

Intervention

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (6)

  • van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann 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):236-44. doi: 10.1111/1471-0528.12542.

    PMID: 24373597RESULT

  • Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.

    PMID: 21858885RESULT

  • 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. Epub 2012 Mar 7.

    PMID: 22399223RESULT

  • Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann 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 Sep 25.

    PMID: 26409016RESULT

  • 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.

    PMID: 19565535RESULT

  • 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.

    PMID: 20034000RESULT

MeSH Terms

Conditions

Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aya Mohr Sasson, M.D

    Sheba Medical Center, Tel-Hashomer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 26, 2018

Study Start

January 10, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)