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

NCT06393608 | Recruiting Phase 2

• 1 other identifier: MP-04-2023-784
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Pain reduction on the visual and numerical pain scale after each application

  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 Outcomes (3)

• other analgesic usage, by filling a medication usage journal

  24hours to 48 hours (duration of the stay at the hospital)

• Satisfaction, opinions of feasibility through a numerical scale

  24hours to 48 hours (duration of the stay at the hospital)

• Adverse effects, self declared in a journal

  24hours to 48 hours (duration of the stay at the hospital)

Study Arms (2)

Magnesium sulfate

ACTIVE COMPARATOR

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

Water

PLACEBO COMPARATOR

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

Other: Water

Interventions

Epsom salt DRUG

Epsom salt solution in water, 25% concentration

Also known as: magnesium sulfate

Magnesium sulfate

Water OTHER

Water

Water

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Person who has given birth vaginally
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antoine Roger: lead
• Hopital Charles Lemoyne: collaborator
• Université de Sherbrooke: collaborator
• Hôpital de Chicoutimi: collaborator
• Hôpital Brome-Missisquoi-Perkins: collaborator
• Hôpital Honoré-Mercier: collaborator

Study Sites (4)

Hôpital de Chicoutimi

Chicoutimi, Quebec, Canada

NOT YET RECRUITING

Hôpital Brome-Missisquoi-Perkins

Cowansville, Quebec, J2K 1K3, Canada

NOT YET RECRUITING

Hôpital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

Hôpital Honoré-Mercier

Saint-Hyacinthe, Quebec, J2S4Y8, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Magnesium Sulfate; Water

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Antoine Roger

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Roger, MD, B.sc

CONTACT

450 466-5630; Antoine.Roger@USherbrooke.ca

Judith Lajeunesse, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a triple-blind study. Parturients will be instructed to apply soaked pads (SSE25 or sterile water) for 15 minutes, as needed, four times a day to the perineum, regardless of which group they are in. They will not know the compound in their bottle, they will only know the number of their bottle. The nurses who distribute the bottles to the patients on their shifts will not know which bottle is sterile water and which is SES.25 In addition, each container will be identical and each liquid will have the same texture and color, making it impossible to identify the contents. As described above, the hospital pharmacy will be responsible for preparing bottles and the pharmacy employees will be the only ones who know the contents. Finally, during data analysis, there will be denominationalization of patients and remittance of data that will not be associated with specific intervention groups, so that data analysis will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: The formation of 2 groups will be done randomly. To do this, the Honoré-Mercier Hospital pharmacy will determine the identification of the A and B bottles (containing either the SSE25 or the sterile water) and will communicate it to the other 2 pharmacies. As a result, the pharmacists will be the only ones in the entire study to know the actual contents of each of the A and B bottles. The bottles will be prepared and identified by the pharmacy and given to the mother-child unit of each of the 3 hospitals. Randomization into the two groups will be done in blocks of 6 patients to limit imbalances between the groups. Participants will receive their assigned A or B bottle and the paperwork for postpartum data collection.The randomization group will be recorded on the consent form and data collection documents. Finally, data will be collected to compare the characteristics of the two groups of study participants.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: May 1, 2024
• Study Start: June 15, 2024
• Primary Completion: December 15, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CA (4)