Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing

November 20, 2023 updated by: The Baruch Padeh Medical Center, Poriya

Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery. A Prospective, Randomized, Double-blind Controlled Study.

Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials.

In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.

Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
    • North
      • Tiberias, North, Israel, 15208
        • Recruiting
        • Baruch Padeh Medical center, Poriya
        • Contact:
          • Enav Yefet, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Woman after spontaneous or operative vaginal delivery
  • Perineal pain score of at least 2 NRS

Exclusion Criteria:

  • Women after cesarean delivery
  • Refuse to participate
  • Under 18 years of age
  • Magnesium sulfate treatment not related to the study
  • Contraindication for magnesium sulfate treatment
  • Workers of the local obstetric department

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pads with cold magnesium sulfate 33% solution
Drug: Magnesium sulfate 33% solution
Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
Placebo Comparator: Pads with cold water
Other: Cold water
Topical pads with cold water will be given 5 times/day for 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of women with perineal pain score< 3 NRS at the day after treatment initiation
Time Frame: 24 hours post enrollment
24 hours post enrollment
Perineal pain intensity according to NRS scale at the day after treatment initiation
Time Frame: 24 hours post enrollment
24 hours post enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of perineal healing using the REEDA scale
Time Frame: 2 days
2 days
Perineal pain intensity according to NRS scale two days after treatment initiation
Time Frame: 2 days (if still in hospital)
2 days (if still in hospital)
Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 5, 2020

First Submitted That Met QC Criteria

July 5, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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