Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393608
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-03-05
Brief Title:
Epsom Salt Compresses to Relieve Perineal for Postpartum Care A Clinical Trial
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
If the Use of Epsom Salt Magnesium Sulfate Compresses 25 Effective in Relieving Perineal Pain in Immediate Postpartum Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 310 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None