Comparing magnesium sulfate and cold water for postpartum perineal pain relief
Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery. A Prospective, Randomized, Double-blind Controlled Study.
This study is testing whether magnesium sulfate or cold water works better to relieve pain and help healing for women after giving birth vaginally.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Baruch Padeh Medical Center, Poriya Government |
| Locations | 1 site (Tiberias, North) |
| Trial ID | NCT04464005 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of topical magnesium sulfate versus cold water in alleviating perineal pain and promoting healing in women after vaginal delivery. Participants with a pain score of at least 2 on a 0-10 numeric rating scale will be randomly assigned to receive either treatment. Pain levels and healing parameters will be measured at baseline, one day, and two days post-treatment to assess outcomes. The study seeks to provide evidence on the efficacy of magnesium sulfate, which has not been sufficiently tested in prior clinical trials.
Who should consider this trial
Good fit: Ideal candidates are women who have recently undergone spontaneous or operative vaginal delivery and are experiencing perineal pain.
Not a fit: Patients who have had a cesarean delivery or those with contraindications to magnesium sulfate treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective non-invasive treatment option for postpartum perineal pain, improving recovery for new mothers.
How similar studies have performed: While topical magnesium sulfate has been used in practice, this specific comparison with cold water has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman after spontaneous or operative vaginal delivery * Perineal pain score of at least 2 NRS Exclusion Criteria: * Women after cesarean delivery * Refuse to participate * Under 18 years of age * Magnesium sulfate treatment not related to the study * Contraindication for magnesium sulfate treatment * Workers of the local obstetric department
Where this trial is running
Tiberias, North
- Baruch Padeh Medical center, Poriya — Tiberias, North, Israel (Recruiting)
Study contacts
- Study coordinator: Enav Yefet, MD/PhD
- Email: enyefet@pmc.gov.il
- Phone: 972-46652306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.