Perineal InjuryPhase 2NCT06393608
Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
A Phase 2 study testing Epsom salt and Water in people with Perineal Injury and Pain, run by Antoine Roger at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Injury, Pain
- What is being tested?
- Epsom salt and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesCanada
- Study dates
- 15 Jun 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Judith Lajeunesse, MD contact
Canada4 sites, 4 recruiting
- Not yet recruiting
Hôpital de Chicoutimi
Chicoutimi, Quebec
Audrey Flamand, MD, (418) 541-1000, audrey.flamand@usherbrooke.ca
Audrey Flamand, MD
- Not yet recruiting
Hôpital Brome-Missisquoi-Perkins
Cowansville, Quebec, J2K 1K3
Aizhen Jade Lefebvre, MD, 450-266-4296 ext. 65734, aizhen.jade.lefebvre@usherbrooke.ca
Anne-Patricia Prévost, MD
- Recruiting
Hôpital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Antoine Roger, MD, 5144764882, antoine.roger@usherbrooke.ca
Amélie Desaulniers, 450-466-5000 ext. 2590, amelie.desaulniers.cisssmc16@ssss.gouv.qc.ca
- Not yet recruiting
Hôpital Honoré-Mercier
Saint-Hyacinthe, Quebec, J2S4Y8
Jacinthe Desranleau, 450 771-3558, jacinthe.desranleau@usherbrooke.ca
Sophie Perona, sophie.perona.cisssme16@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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
- Conditions
- Perineal Injury, Pain
- Being tested
- Epsom salt, Water
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epsom saltDrug
Also called magnesium sulfate
Epsom salt solution in water, 25% concentration
WaterOther
Water
| Study group | Role | What they receive |
|---|---|---|
| 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]). Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24hours to 48 hours (duration of the stay at the hospital)
Secondary outcomes (3)
other analgesic usage, by filling a medication usage journal
It includes usually available analgesics, such as acetaminophen, anti-inflammatories, topical analgesics and ice.
Measured: 24hours to 48 hours (duration of the stay at the hospital)
Satisfaction, opinions of feasibility through a numerical scale
Participants will have to fill this part of their diary before they leave the hospital.
Measured: 24hours to 48 hours (duration of the stay at the hospital)
Adverse effects, self declared in a journal
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.
Measured: 24hours to 48 hours (duration of the stay at the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Jun 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antoine Roger
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Charles Lemoyne, Université de Sherbrooke, Hôpital de Chicoutimi, Hôpital Brome-Missisquoi-Perkins, Hôpital Honoré-Mercier
- Responsible party
- Sponsor-investigator, Antoine Roger, Université de Sherbrooke
- Investigators
- Antoine Roger, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393608
- Sponsor's protocol ID
- MP-04-2023-784
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If the Use of Epsom Salt (magnesium Sulfate) Compresses 25% Effective in Relieving Perineal Pain in Immediate Postpartum Patients?
- ClinicalTrials.gov ID
- NCT06393608
- Acronym / sponsor ID
- MP-04-2023-784
- Conditions
- Perineal Injury, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Antoine RogerUniversity, hospital or other
- Collaborators
- Hopital Charles Lemoyne, Université de Sherbrooke, Hôpital de Chicoutimi, Hôpital Brome-Missisquoi-Perkins, Hôpital Honoré-Mercier
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Active comparator | Drug: Epsom saltPatients 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]). |
| Water | Placebo comparator | Other: WaterPatients in the second group will receive an amber bottle of 250 milliliters containing the placebo.The placebo is sterile water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Hemodynamic instability
- Surgical procedure such as a cesarean section
- Transfer to another hospital
- Transfer to another care unit
- Chronic use of narcotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epsom saltAlso: magnesium sulfateEpsom salt solution in water, 25% concentration | Drug | Magnesium sulfate |
| WaterWater | Other | Water |
Primary outcome
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)
3 secondary outcomes
other analgesic usage, by filling a medication usage journal
Time frame: 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)
Adverse effects, self declared in a journal
Time frame: 24hours to 48 hours (duration of the stay at the hospital)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Childbirth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Lajeunesse, MD contact
Antoine Roger principal investigator
Université de Sherbrooke
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epsom salt and Water in people with Perineal Injury and Pain, run by Antoine Roger at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Roger, MD, B.sc (450 466-5630, Antoine.Roger@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.