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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pads with cold magnesium sulfate 33% solution | Experimental |
| |
| Pads with cold water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate 33% solution | Drug | Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of women with perineal pain score< 3 NRS at the day after treatment initiation | 24 hours post enrollment | |
| Perineal pain intensity according to NRS scale at the day after treatment initiation | 24 hours post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of perineal healing using the REEDA scale | 2 days | |
| Perineal pain intensity according to NRS scale two days after treatment initiation | 2 days (if still in hospital) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enav Yefet, MD/PhD | Contact | 972-46652306 | enyefet@pmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baruch Padeh Medical center, Poriya | Recruiting | Tiberias | North | 15208 | Israel |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Cold water | Other | Topical pads with cold water will be given 5 times/day for 15 minutes |
|
| Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids |
| 2 days |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004364 | Pharmaceutical Preparations |