Recruiting
Phase 2

Epsom Salt

Sponsor:

Antoine Roger

Code:

NCT06393608

Conditions

Perineal Injury

Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Epsom salt

Water

Study Details

Brief summary:

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.

Conditions

Perineal Injury

Pain

Study ID

NCT06393608

Start date

Jun 15, 2024

Status verified date

Dec, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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% \[SSE25\]).

placebo comparator: Water

Patients in the second group will receive an amber bottle of 250 milliliters containing the placebo.The placebo is sterile water.

Interventions

Epsom salt

Epsom salt solution in water, 25% concentration

Water

Water

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Antoine Roger, MD, B.sc

450 466-5630Antoine.Roger@USherbrooke.ca

Locations

Hôpital Charles Lemoyne

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Contacts

Antoine Roger, MD

5144764882antoine.roger@usherbrooke.ca

Amélie Desaulniers

450-466-5000amelie.desaulniers.cisssmc16@ssss.gouv.qc.ca

More Information

Sponsor

Antoine Roger

Last update posted

Dec 19, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Antoine Roger on 2024-12-19.