Epsom Salt Compresses for Postpartum Perineal Pain

Recruiting at 3 trial locations

Overseen By Judith Lajeunesse, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Antoine Roger

Must not be taking: Narcotics

Disqualifiers: Hemodynamic instability, Cesarean, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 days

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Epsom salt compresses can reduce perineal pain after childbirth. Researchers will compare the effectiveness of Epsom salt compresses to plain water compresses. Participants may use the compresses up to four times a day while in the hospital. Women who have given birth vaginally and are staying in a specific hospital might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Epsom salt compresses are likely to be safe for postpartum perineal pain relief?

Research has shown that Epsom salt compresses, containing 25% magnesium sulfate, may help reduce pain after childbirth. A recent study found that applying magnesium sulfate to the skin decreased the intensity and duration of labor pain, suggesting it might also alleviate post-birth pain.

Epsom salts are generally safe for skin use and have been part of health treatments for many years. There are no major reports of negative effects from similar skin applications. As this is an early-phase trial, the researchers are still testing its safety for this specific use, but past experiences provide some reassurance. Participants in the trial will likely be asked to report any side effects experienced. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Epsom salt compresses for postpartum perineal pain because they offer a natural alternative with a unique active ingredient—magnesium sulfate. Unlike typical treatments like pain relievers or ice packs, Epsom salt compresses use magnesium's anti-inflammatory properties to potentially ease pain and swelling more effectively. This treatment is also non-invasive and easy to apply, making it a convenient option for new mothers seeking relief.

What evidence suggests that Epsom salt compresses might be an effective treatment for postpartum perineal pain?

Research has shown that magnesium sulfate, or Epsom salt, can help reduce pain. A recent study found that applying magnesium sulfate to the skin significantly reduced the length and intensity of labor pain. Although this study focused on labor pain, it suggests that Epsom salt might also alleviate other types of pain, such as postpartum discomfort. In this trial, one group of participants will receive Epsom salt compresses, while another group will receive a placebo treatment with sterile water. Warm compresses are already known to help with postpartum pain, and adding Epsom salt might enhance their effectiveness. Researchers are investigating Epsom salt compresses for postpartum care, aiming to provide similar pain relief. ^{1 2 4 5 6}

Who Is on the Research Team?

Antoine Roger

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for new mothers who had a vaginal delivery, with or without perineal tear, at specific hospitals in Chicoutimi, Charles-Le Moyne, or Honoré-Mercier. Participants must consent to the study and speak French or English.

Inclusion Criteria

I have given birth vaginally, with or without any degree of perineal tear.

Planned hospital stay at the mother-child unit of the Hôpital de Chicoutimi, Hôpital Charles-Le Moyne, or Hôpital Honoré-Mercier

Obtaining consent for the study

Exclusion Criteria

Chronic use of narcotics

Inability to complete the logbook

Unsigned consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants apply compresses soaked in 25% magnesium sulfate or placebo on the perineum for 15 minutes, up to four times a day during their hospital stay

1-2 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain reduction and adverse effects

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Epsom Salt Compresses

Trial Overview The trial tests if Epsom salt compresses (25% magnesium sulfate) can relieve postpartum perineal pain compared to placebo (water-soaked compresses). Women will use these compresses up to four times daily during their hospital stay and record their pain levels.

How Is the Trial Designed?

Group I: Magnesium sulfate Active Control 1 Intervention

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% \[SSE25\]).

Group II: Water Placebo Group 1 Intervention

Patients in the second group will receive an amber bottle of 250 milliliters containing the placebo.The placebo is sterile water.

Epsom Salt Compresses is already approved in United States, European Union for the following indications:

Approved in United States as Magnesium sulfate for:

• Relief of perineal pain and swelling postpartum

Approved in European Union as Magnesium sulfate for:

• Relief of perineal pain and swelling postpartum

Who Is Running the Clinical Trial?

Antoine Roger

Lead Sponsor

Trials

1

Recruited

90+

Hopital Charles Lemoyne

Collaborator

Trials

7

Recruited

1,800+

Hôpital Brome-Missisquoi-Perkins

Collaborator

Trials

1

Recruited

90+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Hôpital de Chicoutimi

Collaborator

Trials

1

Recruited

90+

Hôpital Honoré-Mercier

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

In a study of 237 women with postpartum perineal pain, ibuprofen (400 mg) and acetaminophen with codeine (600 mg) were found to have similar pain relief effectiveness, with mean pain ratings of 3.4 and 3.3 respectively.

However, ibuprofen was associated with significantly fewer side effects (52.4% vs. 71.7%) compared to acetaminophen with codeine, making it a potentially safer and more cost-effective option for managing postpartum pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen versus acetaminophen with codeine for the relief of perineal pain after childbirth: a randomized controlled trial. Peter, EA., Janssen, PA., Grange, CS., et al.[2020]

Perineal trauma and pain are common after vaginal birth, and midwives can play a crucial role in helping mothers manage this discomfort, which can affect their transition to motherhood.

Local anaesthetic agents are highlighted as effective tools for relieving perineal pain, suggesting a need for further research to enhance postnatal care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineal pain in focus: reviewing topical anaesthetic treatments. Byrom, A.[2015]

A systematic review of 17 randomized controlled trials involving 1132 women found that a single dose of aspirin significantly improves pain relief for postpartum perineal pain compared to placebo, with a risk ratio of 2.03, indicating more women experienced adequate pain relief.

Aspirin also reduced the need for additional pain relief without increasing maternal adverse effects, although the evidence quality was low, and the studies did not include breastfeeding women, limiting applicability to current postpartum care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin (single dose) for perineal pain in the early postpartum period. Molakatalla, S., Shepherd, E., Grivell, RM.[2021]

An implementation study in a public maternity hospital in São Paulo showed that strategies like professional training and care protocols significantly improved compliance with evidence-based practices for managing perineal pain in new mothers.

After the intervention, audits revealed that nursing care practices for perineal pain management improved, indicating that the strategies effectively enhanced the quality of care based on scientific evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based practices in the perineal pain management in the postpartum period. Tomaz, RGO., Brito, APA., Riesco, MLG.[2021]

In a study of 50 women who had vaginal deliveries with episiotomy, the median perineal pain reported was 5 on a Numeric Scale, indicating moderate pain levels in the postpartum period.

The study identified that perineal pain was characterized by various sensations such as pulsing and stinging, and significantly limited activities like sitting, lying down, and walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Measurement and characteristics of pain after episiotomy and its relationship with the activity limitations]. Beleza, AC., Ferreira, CH., Sousa, Ld., et al.[2019]

In a study of 40 postpartum patients, cold sitz baths were found to be significantly more effective than warm sitz baths in relieving perineal pain after an episiotomy.

Patients reported the most pain relief immediately after using cold sitz baths, indicating a rapid and effective method for managing postpartum discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of cold and warm sitz baths for relief of postpartum perineal pain. Ramler, D., Roberts, J.[2019]

Warm perineal compress during the second stage of labor significantly reduces postpartum pain and the incidence of second and third-degree perineal tears, as well as the need for episiotomy, based on a meta-analysis of 14 studies involving various trial designs.

The use of warm compresses also increases the likelihood of having an intact perineum after childbirth, indicating a beneficial effect on maternal outcomes during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of warm perineal compress on perineal trauma and postpartum pain: a systematic review with meta-analysis and trial sequential analysis. Maghalian, M., Alikamali, M., Nabighadim, M., et al.[2023]

The implementation of evidence-based practices significantly improved the management of perineal pain among postpartum women, with compliance rates for staff education and pain assessment reaching 100%.

Postpartum women experienced a notable reduction in perineal pain due to increased use of analgesics and ice packs, demonstrating the effectiveness of targeted educational strategies for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of perineal pain among postpartum women in an obstetric and gynecological hospital in China: a best practice implementation project. Zhang, Y., Huang, L., Ding, Y., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06393608

Study Details | NCT06393608 | Epsom Salt Compresses to ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12445314/

Effectiveness of Vaginal Magnesium Sulfate on Pain and ... A recent clinical trial conducted in 2023 reported that topical magnesium sulfate application significantly reduced the duration and intensity of labour pain, ...

3. withpower.com withpower.com/trial/phase-2-perineal-injury-4-2024-ffbe4

Epsom Salt Compresses for Postpartum Perineal Pain The research does not directly address Epsom Salt Compresses, but it does show that warm compresses can help reduce postpartum perineal pain. Epsom salt, which ...

4. researchgate.net researchgate.net/publication/381617304_Is_the_use_of_topical_25_magnesium_sulfate_Epsom_salt_effective_in_relieving_perineal_pain_during_immediate_postpartum_care_A_randomized_controlled_trial

Is the use of topical 25% magnesium sulfate (Epsom salt) ... This study aims to determine whether compresses soaked in 25% magnesium sulfate in sterile water can alleviate perineal pain in women immediately after ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11270768/

Efficacy and safety of 12-hour versus 24-hour magnesium ... Our study showed no statistically significant difference in effectiveness and toxicity risk between the 12-h and 24-h regimens.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06393608/epsom-salt-compresses-to-relieve-perineal-for-postpartum-care-a-clinical-trial

Epsom Salt Compresses to Relieve Perineal for ... The goal of this clinical trial is to determine if topical application of compresses soaked in 25% magnesium sulfate on painful perineum ...