Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epsom salt, Water.
- Who it may be relevant to
- Registry conditions: Perineal Injury, Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
If the Use of Epsom Salt (magnesium Sulfate) Compresses 25% Effective in Relieving Perineal Pain in Immediate Postpartum Patients?
Overview
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
Interventions
- Drug Epsom salt
Epsom salt solution in water, 25% concentration - Other Water
Water
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 4 centers
- Hôpital de Chicoutimi — Chicoutimi
- Hôpital Brome-Missisquoi-Perkins — Cowansville
- Hôpital Charles Lemoyne — Greenfield Park
- Hôpital Honoré-Mercier — Saint-Hyacinthe
Identifiers
NCT: NCT06393608 · MP-04-2023-784