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

Trial Summary

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.

What data supports the effectiveness of 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 contains magnesium sulfate, is often used for its soothing properties in other conditions, suggesting it might also help with perineal pain. ^{1 2 3 4 5}

How does the treatment of Epsom Salt Compresses for postpartum perineal pain differ from other treatments?

Epsom Salt Compresses are unique because they use magnesium sulfate, which is known for its soothing and anti-inflammatory properties, to relieve postpartum perineal pain. Unlike topical anesthetics or pain medications like aspirin, this treatment is applied externally as a compress, offering a natural and gentle alternative for pain relief. ^{1 5 6 7 8}

What is the purpose of 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.

Research Team

Antoine Roger

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

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

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

Languages spoken: French, English or both

Exclusion Criteria

Transfer to another hospital

I have been moved to a different care unit.

Chronic use of narcotics

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A comparison of cold and warm sitz baths for relief of postpartum perineal pain. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Ibuprofen versus acetaminophen with codeine for the relief of perineal pain after childbirth: a randomized controlled trial. [2020]

3. Germany 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. [2023]

4. Brazil pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based practices in the perineal pain management in the postpartum period. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Brazil pubmed.ncbi.nlm.nih.gov

[Measurement and characteristics of pain after episiotomy and its relationship with the activity limitations]. [2019]

7. Australia 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. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Aspirin (single dose) for perineal pain in the early postpartum period. [2021]