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

NCT ID: NCT06393608

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Perineal Injury Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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% \[SSE25\]).

Group Type ACTIVE_COMPARATOR

Epsom salt

Intervention Type DRUG

Epsom salt solution in water, 25% concentration

Water

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

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Water

Interventions

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Epsom salt

Epsom salt solution in water, 25% concentration

Intervention Type DRUG

Water

Water

Intervention Type OTHER

Other Intervention Names

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magnesium sulfate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital Charles Lemoyne

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role collaborator

Hôpital de Chicoutimi

UNKNOWN

Sponsor Role collaborator

Hôpital Brome-Missisquoi-Perkins

UNKNOWN

Sponsor Role collaborator

Hôpital Honoré-Mercier

UNKNOWN

Sponsor Role collaborator

Antoine Roger

OTHER

Sponsor Role lead

Responsible Party

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Antoine Roger

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Antoine Roger

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Hôpital de Chicoutimi

Chicoutimi, Quebec, Canada

Site Status NOT_YET_RECRUITING

Hôpital Brome-Missisquoi-Perkins

Cowansville, Quebec, Canada

Site Status NOT_YET_RECRUITING

Hôpital Charles Lemoyne

Greenfield Park, Quebec, Canada

Site Status RECRUITING

Hôpital Honoré-Mercier

Saint-Hyacinthe, Quebec, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Antoine Roger, MD, B.sc

Role: CONTACT

Phone: 450 466-5630

Email: [email protected]

Judith Lajeunesse, MD

Role: CONTACT

Facility Contacts

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Audrey Flamand, MD

Role: primary

Audrey Flamand, MD

Role: backup

Aizhen Jade Lefebvre, MD

Role: primary

Anne-Patricia Prévost, MD

Role: backup

Aizhen Jade Lefebvre, MD

Role: backup

Antoine Roger, MD

Role: primary

Amélie Desaulniers

Role: backup

Jacinthe Desranleau

Role: primary

Sophie Perona

Role: backup

Jacinthe Desranleau, MD

Role: backup

Other Identifiers

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MP-04-2023-784

Identifier Type: -

Identifier Source: org_study_id