Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
- Registration Number
- NCT06393608
- Lead Sponsor
- Antoine Roger
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Water Water Patients in the second group will receive an amber bottle of 250 milliliters containing the placebo.The placebo is sterile water. Magnesium sulfate Epsom salt 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% \[SSE25\]).
- Primary Outcome Measures
Name Time Method Pain reduction on the visual and numerical pain scale after each application 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)
- Secondary Outcome Measures
Name Time Method other analgesic usage, by filling a medication usage journal 24hours to 48 hours (duration of the stay at the hospital) It includes usually available analgesics, such as acetaminophen, anti-inflammatories, topical analgesics and ice.
Satisfaction, opinions of feasibility through a numerical scale 24hours to 48 hours (duration of the stay at the hospital) Participants will have to fill this part of their diary before they leave the hospital.
Adverse effects, self declared in a journal 24hours to 48 hours (duration of the stay at the hospital) 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.
Trial Locations
- Locations (4)
Hôpital de Chicoutimi
🇨🇦Chicoutimi, Quebec, Canada
Hôpital Brome-Missisquoi-Perkins
🇨🇦Cowansville, Quebec, Canada
Hôpital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Hôpital Honoré-Mercier
🇨🇦Saint-Hyacinthe, Quebec, Canada