Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

Not Applicable

• Conditions: Perineal Swelling; Perineal Pain; Vaginal Delivery
• Interventions: Other: Cold pads soaked in water; Other: Cold pads soaked in Magnesium sulfate solution

• Registration Number: NCT02024256
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-25
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2013-12-31
• Study Start: 2014-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 206

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water	Cold pads soaked in water	Pads soaked with cold water
Magnesium sulfate	Cold pads soaked in Magnesium sulfate solution	Pads soaked in cold magnesium sulfate solution

Primary Outcome Measures

Name	Time	Method
Reduction in perineal swelling	3 days
Reduction in the level of perineal pain	3 days

Secondary Outcome Measures

Name	Time	Method
Reduction in hemorrhoids pain and swelling	3 days

Trial Locations

Locations (2)

HeEmek medical center; 🇮🇱 Afula, Israel

HaEmek medical center; 🇮🇱 Afula, Israel