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.
NCT ID NCT04464005
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials. In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery. Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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131 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Sep 2025
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baruch Padeh Medical center, Poriya
Tiberias, North, 15208, Israel