NCT02024256

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

December 25, 2013

Last Update Submit

September 29, 2016

Conditions

Vaginal DeliveryPerineal SwellingPerineal Pain

Keywords

Vaginal deliveryPerineal swellingPerineal painMgSo4Magnesium sulfateCold water

Outcome Measures

Primary Outcomes (2)

  • Reduction in the level of perineal pain

    3 days

  • Reduction in perineal swelling

    3 days

Secondary Outcomes (1)

  • Reduction in hemorrhoids pain and swelling

    3 days

Study Arms (2)

Magnesium sulfate

ACTIVE COMPARATOR

Pads soaked in cold magnesium sulfate solution

Other: Cold pads soaked in Magnesium sulfate solution

Water

SHAM COMPARATOR

Pads soaked with cold water

Other: Cold pads soaked in water

Interventions

Cold pads soaked in Magnesium sulfate solutionOTHER
Also known as: Epson salt, MgSo4
Magnesium sulfate
Cold pads soaked in waterOTHER
Water

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HeEmek medical center

Afula, 18101, Israel

RECRUITING

HaEmek medical center

Afula, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33034900DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Zohar Nahum, MD

    HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zohar Nahum, MD

CONTACT

97246494158nachum_zo@clalit.org.il

Irit Friedman, MA

CONTACT

972546202261iritdavid@gmail.com, irit_da@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2013

First Posted

December 31, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2018

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

IL(2)