Clinical trial NCT02024256: Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Delivery
Perineal Swelling
Perineal Pain
Keywords: Vaginal delivery
Perineal swelling
Perineal pain
MgSo4
Magnesium sulfate
Cold water
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in the level of perineal pain
timeFrame: 3 days
measure: Reduction in perineal swelling
timeFrame: 3 days
Secondary outcomes:
measure: Reduction in hemorrhoids pain and swelling
timeFrame: 3 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HeEmek medical center
city: Afula
country: Israel
facility: HaEmek medical center
Study officials:
affiliation: HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel
name: Zohar Nahum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.