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

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Delivery; Perineal Swelling; Perineal Pain
• Intervention / Treatment: Other: Cold pads soaked in Magnesium sulfate solution; Other: Cold pads soaked in water

• Study Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • HaEmek Medical Center
    • Principal Investigator: Nahum Zohar, MD
  • Afula, Israel, 18101
    • Recruiting
    • HeEmek medical center
    • Contact: Zohar Nahum, md; Phone Number: 97241584649; Email: nachum_zo@clalit.org.il
    • Contact: Irit Friedman; Phone Number: 972546202261; Email: iritdavid@gmail.com, irit_da@clalit.org.il
    • Principal Investigator: Zohar Nahum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium sulfate; Pads soaked in cold magnesium sulfate solution	Other: Cold pads soaked in Magnesium sulfate solution; Other Names: Epson salt, MgSo4
Sham Comparator: Water; Pads soaked with cold water	Other: Cold pads soaked in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the level of perineal pain	3 days
Reduction in perineal swelling	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in hemorrhoids pain and swelling	3 days

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Zohar Nahum, MD, HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel

Publications and helpful links

General Publications

• East CE, Dorward ED, Whale RE, Liu J. Local cooling for relieving pain from perineal trauma sustained during childbirth. Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: December 25, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Magnesium sulfate; Vaginal delivery; Perineal swelling; Perineal pain; MgSo4; Cold water
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: MG33