NCT02615236

Brief Summary

The aim of the study is to evaluate the role of routine perineal scan using 2D ultrasound immediatly after delivery to diagnose hidden perineal trauma that might affect patient's fecal continance

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

November 20, 2015

Last Update Submit

November 15, 2018

Conditions

Episiotomy

Outcome Measures

Primary Outcomes (1)

  • anal incontinence

    patients will be reviewed for anal incontinence 3 months after delivery

    3 months after delivery

Secondary Outcomes (2)

  • pain score

    3 and 12 month after delivery

  • questionnaire for effect on quality of life

    3 and 12 month after delivery

Study Arms (2)

PERINEAL ULTRASOUND

EXPERIMENTAL

Perineal ultrasound with a bedside scanner by inserting a the probe into the perineum and reviewed in real-time

Device: perineal ultrasound

Clinical diagnosis

ACTIVE COMPARATOR

Diagnosis of OASIS will be clinically

Procedure: Clinical diagnosis

Interventions

perineal ultrasoundDEVICE

transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women

PERINEAL ULTRASOUND
Clinical diagnosisPROCEDURE

diagnosis of OASIS clinically

Clinical diagnosis

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous women immediately after vaginal delivery

You may not qualify if:

  • history of anal incontinence
  • previous anal sphincteric injuries
  • previous anal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Clinical Laboratory Techniques

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ahmed kotb, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ahmed Kotb

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 26, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)