Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAntoine Roger
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Hemodynamic instability
Surgical procedure such as a cesarean section
Transfer to another hospital
Transfer to another care unit
Trial design
Design model
Parallel
Treatments tested in this trial
Epsom salt
DrugEpsom salt solution in water, 25% concentration
Water
Other interventionWater
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Magnesium sulfateActive comparator 1 intervention
Group B: WaterPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
24hours to 48 hours (duration of the stay at the hospital)Secondary outcomes
1
other analgesic usage, by filling a medication usage journal
It includes usually available analgesics, such as acetaminophen, anti-inflammatories, topical analgesics and ice.
Time frame
24hours to 48 hours (duration of the stay at the hospital)2
Satisfaction, opinions of feasibility through a numerical scale
Participants will have to fill this part of their diary before they leave the hospital.
Time frame
24hours to 48 hours (duration of the stay at the hospital)3
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.
Time frame
24hours to 48 hours (duration of the stay at the hospital)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Antoine Roger
Lead sponsor
Université de Sherbrooke
Sponsor institution
Hopital Charles Lemoyne
Collaborator
Université de Sherbrooke
Collaborator
Hôpital de Chicoutimi
Collaborator
Hôpital Brome-Missisquoi-Perkins
Collaborator
Hôpital Honoré-Mercier
Collaborator
Source ClinicalTrials.gov