Episiotomy Scar Massage for Postpartum Pelvic Health

(EPIS Trial)

Overseen By Gina-Marie Cerantola, BSc, DPT

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Vaginal infection, Urinary tract infection, Gynecological surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 6 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if teaching new mothers to massage their childbirth scars can improve their pelvic health. The study will involve women who have given birth and have healed scars. The massage is expected to make the scar tissue more flexible and reduce discomfort.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on postpartum pelvic health and scar massage, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment Episiotomy Scar Tissue Self-Scar Massage for postpartum pelvic health?

Research suggests that perineal massage (gentle rubbing of the area between the vagina and anus) during labor can reduce severe perineal trauma, which may imply benefits for postpartum recovery, including scar massage. ^{1 2 3 4 5}

How does episiotomy scar tissue self-scar massage differ from other treatments for postpartum pelvic health?

Episiotomy scar tissue self-scar massage is unique because it involves self-administered massage to improve the flexibility and reduce pain of scar tissue, unlike surgical procedures or routine episiotomies which can lead to complications. This approach empowers women to manage their own recovery and potentially improve sexual function and comfort without the need for medical intervention. ^{1 4 6 7 8}

Research Team

Erin Brennand, MD, MSc

Principal Investigator

University of Calgary

Eligibility Criteria

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.

Inclusion Criteria

Sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.

Healed episiotomy as confirmed to them by their maternity care provider or family doctor at their postpartum check

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group perform self-scar tissue massage for 6 weeks, while the control group receives routine postnatal care.

6 weeks

Baseline assessment at start, follow-up at 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments repeated 18 weeks after baseline.

12 weeks

Follow-up assessment at 18 weeks

Treatment Details

Interventions

• Episiotomy Scar Tissue Self-Scar Massage

Trial Overview 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.

Participant Groups

Group I: Episiotomy and Vaginal/Perineal Tear Self-Scar Massage Experimental Treatment 1 Intervention

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

Group II: Standard Postnatal Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Routine episiotomy in modern obstetrics. Is it necessary?]. [2006]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Mediolateral versus lateral episiotomy and their effect on postpartum coital activity and dyspareunia rate 3 and 6 months postpartum. [2017]

3. Singapore pubmed.ncbi.nlm.nih.gov

Prolonged survival after episiotomy recurrence of cervical cancer complicating pregnancy. [2020]

4. Iran pubmed.ncbi.nlm.nih.gov

Perineal Massage for Prevention of Perineal Trauma and Episiotomy During Labor: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Episiotomy use among residents and faculty compared with private practitioners. [2022]

6. Turkey pubmed.ncbi.nlm.nih.gov

Assessment of the Effects of Perineoplasty on Female Sexual Function. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence of Perineal Tear Peripartum after Two Antepartum Perineal Massage Techniques: A Non-Randomised Controlled Trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The use of perineal massage in the second stage of labor and follow-up of postpartum perineal outcomes. [2015]