Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

Vaginal Delivery Clinical Trial

— MgSo4  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024256
• Other study ID #: MG33
• Status: Recruiting
• Phase: N/A
• First received: December 25, 2013
• Last updated: September 29, 2016
• Start date: January 2014

Study information

• Verified date: September 2016
• Source: HaEmek Medical Center, Israel
• Contact: Zohar Nahum, MD
• Phone: 97246494158
• Email: nachum_zo[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perineal Pain
• Perineal Swelling
• Vaginal Delivery

Intervention

Other:
• Cold pads soaked in Magnesium sulfate solution

• Cold pads soaked in water

Locations

Country	Name	City	State
Israel	HaEmek medical center	Afula
Israel	HeEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the level of perineal pain		3 days	No
Primary	Reduction in perineal swelling		3 days	No
Secondary	Reduction in hemorrhoids pain and swelling		3 days	No