Clinical trial NCT06393608: Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
Official title: If the Use of Epsom Salt (magnesium Sulfate) Compresses 25% Effective in Relieving Perineal Pain in Immediate Postpartum Patients?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Perineal Injury
Pain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Hopital Charles Lemoyne
name: Université de Sherbrooke
name: Hôpital de Chicoutimi
name: Hôpital Brome-Missisquoi-Perkins
name: Hôpital Honoré-Mercier
First posted: 2024-05-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain reduction on the visual and numerical pain scale after each application
timeFrame: 24hours to 48 hours (duration of the stay at the hospital)
Secondary outcomes:
measure: other analgesic usage, by filling a medication usage journal
timeFrame: 24hours to 48 hours (duration of the stay at the hospital)
measure: Satisfaction, opinions of feasibility through a numerical scale
timeFrame: 24hours to 48 hours (duration of the stay at the hospital)
measure: Adverse effects, self declared in a journal
timeFrame: 24hours to 48 hours (duration of the stay at the hospital)
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
facility: Hôpital de Chicoutimi
state: Quebec
city: Cowansville
country: Canada
facility: Hôpital Brome-Missisquoi-Perkins
state: Quebec
city: Greenfield Park
country: Canada
facility: Hôpital Charles Lemoyne
state: Quebec
city: Saint-Hyacinthe
country: Canada
facility: Hôpital Honoré-Mercier
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Antoine Roger
role: PRINCIPAL_INVESTIGATOR
References: