Vaginal Delivery Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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