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Episiotomy Scar Massage for Postpartum Pelvic Health (EPIS Trial)

N/A

Recruiting

Led By Erin Brennand, MD, MSc

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6-10 weeks postpartum after vaginal delivery with episiotomy

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

EPIS Trial Summary

This trial will examine if a larger RCT studying the effects of self-scar tissue massage of episiotomy scar tissue on pelvic health outcomes is possible.

Who is the study for?

This trial is for first-time mothers over 18, within 6-10 weeks postpartum after a vaginal delivery with episiotomy. They must have healed scars as confirmed by their doctor and be able to understand English well enough to follow an instructional video and fill out questionnaires.Check my eligibility

What is being tested?

The study tests if self-scar tissue massage on the perineal area can improve pelvic health in new moms. Participants will either perform self-massage following an instructional video or receive routine care without massage, to compare outcomes using pelvic health questionnaires.See study design

What are the potential side effects?

Since this intervention involves non-invasive self-massage, side effects are expected to be minimal but may include discomfort or pain at the scar site during or after performing the massage.

EPIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 6-10 weeks postpartum after a vaginal delivery with an episiotomy.

Select...

I am 18 years old or older.

EPIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data

Number of The Carol Scale with missing data

Number of participants to complete self-scar massage protocol as intended

+2 more

EPIS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Episiotomy and Vaginal/Perineal Tear Self-Scar MassageExperimental Treatment1 Intervention

This Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue.

Group II: Standard Postnatal CareActive Control1 Intervention

This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,024 Total Patients Enrolled

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,536 Total Patients Enrolled

Alberta Innovates Health SolutionsOTHER

53 Previous Clinical Trials

94,295 Total Patients Enrolled

Media Library

Episiotomy Scar Tissue Self-Scar Massage Clinical Trial Eligibility Overview. Trial Name: NCT05908292 — N/A

Perineal Tears Research Study Groups: Episiotomy and Vaginal/Perineal Tear Self-Scar Massage, Standard Postnatal Care

Perineal Tears Clinical Trial 2023: Episiotomy Scar Tissue Self-Scar Massage Highlights & Side Effects. Trial Name: NCT05908292 — N/A

Episiotomy Scar Tissue Self-Scar Massage 2023 Treatment Timeline for Medical Study. Trial Name: NCT05908292 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research protocol still open to participants?

"According to clinicaltrials.gov, this trial has ceased participant recruitment since June 8th 2023 - the date of its last update after its initial posting on July 1st, 2023. Fortunately, 36 other studies are still actively enrolling patients presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT

2023. "Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05908292.

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