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Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery (MgSo4)

This study is currently recruiting participants.
Verified September 2016 by HaEmek Medical Center, Israel
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024256
First Posted: December 31, 2013
Last Update Posted: September 30, 2016
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.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  Purpose

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 Intervention
Vaginal Delivery Perineal Swelling Perineal Pain Other: Cold pads soaked in Magnesium sulfate solution Other: Cold pads soaked in water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Reduction in the level of perineal pain [ Time Frame: 3 days ]
  • Reduction in perineal swelling [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • Reduction in hemorrhoids pain and swelling [ Time Frame: 3 days ]

Estimated Enrollment: 206
Study Start Date: January 2014
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024256


Contacts
Contact: Zohar Nahum, MD 97246494158 nachum_zo@clalit.org.il
Contact: Irit Friedman, MA 972546202261 iritdavid@gmail.com, irit_da@clalit.org.il

Locations
Israel
HeEmek medical center Recruiting
Afula, Israel, 18101
Contact: Zohar Nahum, md    97241584649    nachum_zo@clalit.org.il   
Contact: Irit Friedman    972546202261    iritdavid@gmail.com, irit_da@clalit.org.il   
Principal Investigator: Zohar Nahum, MD         
HaEmek medical center Recruiting
Afula, Israel
Principal Investigator: Nahum Zohar, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Zohar Nahum, MD HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02024256     History of Changes
Other Study ID Numbers: MG33
First Submitted: December 25, 2013
First Posted: December 31, 2013
Last Update Posted: September 30, 2016
Last Verified: September 2016

Keywords provided by HaEmek Medical Center, Israel:
Vaginal delivery
Perineal swelling
Perineal pain
MgSo4
Magnesium sulfate
Cold water

Additional relevant MeSH terms:
Pharmaceutical Solutions
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents