NCT03039582

Brief Summary

Anovaginal distance measured by palpation and perineal ultrasound are similar.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

January 30, 2017

Last Update Submit

February 10, 2017

Conditions

Perineal TearObstetric Trauma

Keywords

perineal tearbidigital palpationperineal ultrasoundpost partum diagnostics

Outcome Measures

Primary Outcomes (1)

  • Correlation between palpated and ultrasound- measured anovaginal distance

    Does palpation give a reliable result?

    immediate

Secondary Outcomes (1)

  • Anal Sphincter rupture incidence

    immediate

Study Arms (3)

Probable grad 2

Perineal laceration Probable grad 2

Diagnostic Test: Bidigital palpationDiagnostic Test: Perineal ultrasound

Suspected grade 3

Perineal laceration Suspected grade 3

Diagnostic Test: Bidigital palpationDiagnostic Test: Perineal ultrasound

Probable grad 3

Perineal laceration Probable grad 3

Diagnostic Test: Bidigital palpationDiagnostic Test: Perineal ultrasound

Interventions

Bidigital palpationDIAGNOSTIC_TEST

palpation of the anovaginal distance with two fingers

Probable grad 2Probable grad 3Suspected grade 3
Perineal ultrasoundDIAGNOSTIC_TEST

ultrasound measurement of the anovaginal distance

Also known as: Vaginal ultrasound, transperineal ultrasound
Probable grad 2Probable grad 3Suspected grade 3

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women just after vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.

    PMID: 26637088BACKGROUND

  • Geller EJ, Robinson BL, Matthews CA, Celauro KP, Dunivan GC, Crane AK, Ivins AR, Woodham PC, Fielding JR. Perineal body length as a risk factor for ultrasound-diagnosed anal sphincter tear at first delivery. Int Urogynecol J. 2014 May;25(5):631-6. doi: 10.1007/s00192-013-2273-x. Epub 2013 Dec 12.

    PMID: 24337585BACKGROUND

  • Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816.

    PMID: 20814874BACKGROUND

  • Shobeiri SA, Nolan TE, Yordan-Jovet R, Echols KT, Chesson RR. Digital examination compared to trans-perineal ultrasound for the evaluation of anal sphincter repair. Int J Gynaecol Obstet. 2002 Jul;78(1):31-6. doi: 10.1016/s0020-7292(02)00068-1.

    PMID: 12113968BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 1, 2017

Study Start

September 1, 2014

Primary Completion

January 31, 2016

Study Completion

January 19, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share