NCT02024256

Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vaginal Delivery
• Perineal Swelling
• Perineal Pain

Interventions

Type	Name	Description
OTHER	Cold pads soaked in Magnesium sulfate solution
OTHER	Cold pads soaked in water

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-01-01
• First posted: 2013-12-31
• Last updated: 2016-09-30

Locations

2 sites across 1 country: Israel