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

NCT04464005 | Unknown Phase 4

• 1 other identifier: 112-19
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women After Delivery With Perineal Pain

Outcome Measures

Primary Outcomes (2)

• Rate of women with perineal pain score< 3 NRS at the day after treatment initiation

  24 hours post enrollment

• Perineal pain intensity according to NRS scale at the day after treatment initiation

  24 hours post enrollment

Secondary Outcomes (3)

• Degree of perineal healing using the REEDA scale

  2 days

• Perineal pain intensity according to NRS scale two days after treatment initiation

  2 days (if still in hospital)

• Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids

  2 days

Study Arms (2)

Pads with cold magnesium sulfate 33% solution

EXPERIMENTAL

Drug: Magnesium sulfate 33% solution

Pads with cold water

PLACEBO COMPARATOR

Other: Cold water

Interventions

Magnesium sulfate 33% solution DRUG

Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes

Pads with cold magnesium sulfate 33% solution

Cold water OTHER

Topical pads with cold water will be given 5 times/day for 15 minutes

Pads with cold water

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

Study Sites (1)

Baruch Padeh Medical center, Poriya

Tiberias, North, 15208, Israel

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate; Solutions

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Pharmaceutical Preparations

Central Study Contacts

Enav Yefet, MD/PhD

CONTACT

972-46652306; enyefet@pmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 9, 2020
• Study Start: November 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-09

Locations

IL (1)