Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial

December 16, 2024 updated by: Antoine Roger

If the Use of Epsom Salt (magnesium Sulfate) Compresses 25% Effective in Relieving Perineal Pain in Immediate Postpartum Patients?

The goal of this clinical trial is to determine if topical application of compresses soaked in 25% magnesium sulfate on painful perineum after birth is effective to alleviate pain.

Researchers will compare this treatment to a placebo, compresses soaked in water. Participants will be invited to use their compresses if needed, for 15 minutes, up to four times a day, during their stay at the hospital after giving birth. They will also have to keep a diary of their usage and of their pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Despite the high frequency of perineal trauma in obstetrics, management of perineal care and pain is highly variable, relying on very few studies, if any. Treatment of the perineum with compresses soaked in a magnesium sulfate (Epsom salt) solution has not previously been studied but is routinely used in some hospitals in Quebec, Canada. Objectives: This study aims to determine whether compresses soaked in 25% magnesium sulfate in sterile water can alleviate perineal pain in women immediately after childbirth. Population and intervention: Women who have just given birth vaginally and report perineal or vulvar pain of 3/10 or more will be recruited and randomized into an intervention group receiving the treatment (compresses soaked in 25% magnesium sulfate) or a control group receiving a placebo (compresses soaked in water). Methods: This multi-centric, double-blinded randomized clinical trial will be conducted in four hospitals in the province of Quebec, Canada. The investigators plan to recruit a total of 104 participants. Participants will be instructed to apply the compresses on the vulva and perineum for 15 minutes, four times per day, if needed. They will be asked to score their pain before and after using the compresses for the length of their hospital stay, typically between 24 and 48 hours. Secondary outcomes include analgesic use, incidence of complications, participant satisfaction, opinions on feasibility, and any adverse effects caused by the compresses. Discussion: This randomized controlled trial will assess whether the treatment is more effective in relieving pain than the placebo. The study will also determine the safety and feasibility of this method for routine postnatal care. This study could contribute in the long term to the standardization of evidence-based practices for the management of postpartum perineal pain in Canadian hospitals

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Judith Lajeunesse, MD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Planned hospital stay at the mother-child unit of the Hôpital de Chicoutimi, Hôpital Charles-Le Moyne, or Hôpital Honoré-Mercier
  • Vaginal delivery with or without perineal tear, any degree of tear, including episiotomies
  • Obtaining consent for the study
  • Languages spoken: French, English or both

Exclusion Criteria:

  • Hemodynamic instability
  • Surgical procedure such as a cesarean section
  • Transfer to another hospital
  • Transfer to another care unit
  • Chronic use of narcotics
  • Inability to complete the logbook
  • Unsigned consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium sulfate
Patients in the first group will receive an amber bottle of 250 milliliters containing treatment.The treatment is a solution of MgSO4 25% with sterile water base (Epsom salt solution, concentrated to 25% [SSE25]).
Drug: Epsom salt
Epsom salt solution in water, 25% concentration
Other Names:
  • magnesium sulfate
Placebo Comparator: Water
Patients in the second group will receive an amber bottle of 250 milliliters containing the placebo.The placebo is sterile water.
Other: Water
Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction on the visual and numerical pain scale after each application
Time Frame: 24hours to 48 hours (duration of the stay at the hospital)
customized visual and numerical pain scale (0-10, 0 being no pain at all and 10 being the worse pain)
24hours to 48 hours (duration of the stay at the hospital)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other analgesic usage, by filling a medication usage journal
Time Frame: 24hours to 48 hours (duration of the stay at the hospital)
It includes usually available analgesics, such as acetaminophen, anti-inflammatories, topical analgesics and ice.
24hours to 48 hours (duration of the stay at the hospital)
Satisfaction, opinions of feasibility through a numerical scale
Time Frame: 24hours to 48 hours (duration of the stay at the hospital)
Participants will have to fill this part of their diary before they leave the hospital.
24hours to 48 hours (duration of the stay at the hospital)
Adverse effects, self declared in a journal
Time Frame: 24hours to 48 hours (duration of the stay at the hospital)
A space in the participant's diary is dedicated for them to declare any benign adverse effects. We don't expect any, since the product is already recognized as safe in literature.
24hours to 48 hours (duration of the stay at the hospital)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antoine Roger

Collaborators

Université de Sherbrooke
Hopital Charles Lemoyne
Hopital de Chicoutimi
Hôpital Brome-Missisquoi-Perkins
Hôpital Honoré-Mercier

Investigators

  • Principal Investigator: Antoine Roger, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-04-2023-784

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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