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

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Perineal Swelling; Perineal Pain; Vaginal Delivery

Treatments: Other: Cold pads soaked in water; Other: Cold pads soaked in Magnesium sulfate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02024256

MG33

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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206 participants in 2 patient groups

Magnesium sulfate

Active Comparator group

Description:

Pads soaked in cold magnesium sulfate solution

Treatment:

Other: Cold pads soaked in Magnesium sulfate solution

Water

Sham Comparator group

Description:

Pads soaked with cold water

Treatment:

Other: Cold pads soaked in water

Sponsor of this trial

Lead Sponsor

HaEmek Medical Center, Israel