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Vaginal Delivery | Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

Vaginal Delivery research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Vaginal Delivery

Perineal Swelling

Perineal Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Cold pads soaked in Magnesium sulfate solution

Other:Cold pads soaked in water

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Magnesium sulfatePads soaked in cold magnesium sulfate solution

WaterPads soaked with cold water

Study Status

Unknown status

Start Date: January 2014

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Reduction in the level of perineal pain

Secondary Outcome: Reduction in hemorrhoids pain and swelling

Study sponsors, principal investigator, and references

Principal Investigator: Zohar Nahum, MD

Lead Sponsor: HaEmek Medical Center, Israel

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02024256

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