Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

Study Overview
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Brief Summary
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The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery. Assessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Those patients who consent to participate in the trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in the study group will receive treatment with pads soaked in a cold aqueous solution of magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive treatment with pads soaked in cold water. Nurses will initiate treatment according to the group to which the patient was randomized. Said pads will be given the patients routinely 5 times a day at regular times. A physician will assess the perineal swelling according to visual (photographed) scale in which severe, moderate, light and no swelling will be defined. Measurement of swelling in centimeters (maximal length and breadth); photography, by a medical photographer or the examining doctor, of the perineal area with a centimeter ruler, before, during and after treatment (photography is dependent on patient approval and is not a precondition to participation in the trial.); and additional examination, on the above basis, will be performed regarding hemorrhoids in the event that a patient has complained of such. A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to the patient being given the pad and an hour following treatment. An additional assessment by the same method will be performed regarding hemorrhoid pain. Any analgesia administered will also be recorded. Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken before and after treatment. Period of follow-up will be 48-72 hours from childbirth.

Official Title
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Comparison Between Treatment With Gauze Soaked With Cold Magnesium Sulfate Solution Against Gauze Soaked With Cold Water for Treatment of Perineal Swelling Following Vaginal Delivery - A Double Blind Placebo Controlled Trial

Conditions
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Vaginal Delivery, Perineal Swelling, Perineal Pain

Intervention / Treatment
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* Other: Cold pads soaked in Magnesium sulfate solution
* Other: Cold pads soaked in water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parturients following normal vaginal birth or vacuum-assisted vaginal delivery reporting of perineal pain equal to or greater than 3 on a 0-10 scale Exclusion Criteria: parturients following cesarean section lack of consent to take part in the study parturients interested in early discharge (within 48 hours of childbirth) girls under 18 years of age

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 |
| --- | --- |
| Active Comparator: Magnesium sulfate<br>Pads soaked in cold magnesium sulfate solution | Other: Cold pads soaked in Magnesium sulfate solution<br> <br> * Other names: Epson salt, MgSo4;|
| Sham Comparator: Water<br>Pads soaked with cold water | Other: Cold pads soaked in water<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the level of perineal pain |  | 3 days | 
| Reduction in perineal swelling |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in hemorrhoids pain and swelling |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal delivery, Perineal swelling, Perineal pain, MgSo4, Magnesium sulfate, Cold water