Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery (MgSo4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02024256|
Recruitment Status : Recruiting
First Posted : December 31, 2013
Last Update Posted : September 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Delivery Perineal Swelling Perineal Pain||Other: Cold pads soaked in Magnesium sulfate solution Other: Cold pads soaked in water||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2018|
Active Comparator: Magnesium sulfate
Pads soaked in cold magnesium sulfate solution
Other: Cold pads soaked in Magnesium sulfate solution
Other Name: Epson salt, MgSo4
Sham Comparator: Water
Pads soaked with cold water
|Other: Cold pads soaked in water|
- Reduction in the level of perineal pain [ Time Frame: 3 days ]
- Reduction in perineal swelling [ Time Frame: 3 days ]
- Reduction in hemorrhoids pain and swelling [ Time Frame: 3 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024256
|Contact: Zohar Nahum, MDfirstname.lastname@example.org|
|Contact: Irit Friedman, MAemail@example.com, firstname.lastname@example.org|
|HeEmek medical center||Recruiting|
|Afula, Israel, 18101|
|Contact: Zohar Nahum, md 97241584649 email@example.com|
|Contact: Irit Friedman 972546202261 firstname.lastname@example.org, email@example.com|
|Principal Investigator: Zohar Nahum, MD|
|HaEmek medical center||Recruiting|
|Principal Investigator: Nahum Zohar, MD|
|Principal Investigator:||Zohar Nahum, MD||HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel|