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Recruiting Phase 2 NCT06393608

NCT06393608 Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial

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Clinical Trial Summary
NCT ID NCT06393608
Status Recruiting
Phase Phase 2
Sponsor Antoine Roger
Condition Perineal Injury
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2024-06-15
Primary Completion 2025-12-15

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Epsom saltWater

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 90 participants in total. It began in 2024-06-15 with a primary completion date of 2025-12-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Antoine Roger, MD, B.sc

✉ Antoine.Roger@USherbrooke.ca

📞 450 466-5630

Principal Investigator

Antoine Roger

PRINCIPAL INVESTIGATOR

Université de Sherbrooke

Frequently Asked Questions

Who can join the NCT06393608 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Perineal Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06393608 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT06393608 currently recruiting?

Yes, NCT06393608 is actively recruiting participants. Contact the research team at Antoine.Roger@USherbrooke.ca for enrollment information.

Where is the NCT06393608 trial being conducted?

This trial is being conducted at Chicoutimi, Canada, Cowansville, Canada, Greenfield Park, Canada, Saint-Hyacinthe, Canada.

Who is sponsoring the NCT06393608 clinical trial?

NCT06393608 is sponsored by Antoine Roger. The principal investigator is Antoine Roger at Université de Sherbrooke. The trial plans to enroll 90 participants.

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