Epsom Salt Compresses to Relieve Perineal for Postpartum Care: A Clinical Trial

Pain Clinical Trial

Official title:

If the Use of Epsom Salt (Magnesium Sulfate) Compresses 25% Effective in Relieving Perineal Pain in Immediate Postpartum Patients?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393608
• Other study ID #: MP-04-2023-784
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Université de Sherbrooke
• Contact: Antoine Roger, MD, B.sc
• Phone: 450 466-5630
• Email: Antoine.Roger[@]USherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 treatement 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Epsom salt
Epsom salt solution in water, 25% concentration

Other:
• Water
Water

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Hopital Charles Lemoyne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction on the visual and numerical pain scale after each application		24hours to 48 hours (duration of the stay at the hospital)
Secondary	other analgesic usage, by filling a medication usage journal	It includes usually available analgesics, such as acetaminophen, anti-inflammatories, topical analgesics and ice.	24hours to 48 hours (duration of the stay at the hospital)
Secondary	Satisfaction, opinions of feasability through a numerical scale	Participants will have to fill this part of their diary before they leave the hospital.	24hours to 48 hours (duration of the stay at the hospital)
Secondary	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 litterature.	24hours to 48 hours (duration of the stay at the hospital)