Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Women After Delivery With Perineal Pain

Intervention / Treatment
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* Drug: Magnesium sulfate 33% solution
* Other: Cold water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pads with cold magnesium sulfate 33% solution<br> | Drug: Magnesium sulfate 33% solution<br>* Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes<br>|
| Placebo Comparator: Pads with cold water<br> | Other: Cold water<br>* Topical pads with cold water will be given 5 times/day for 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids |  | 2 days |