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

Phase 4

Recruiting

• Conditions: Women After Delivery With Perineal Pain
• Interventions: Drug: Magnesium sulfate 33% solution; Other: Cold water

• Registration Number: NCT04464005
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-05
• Study First Submitted QC: 2020-07-05
• Study First Posted: 2020-07-09
• Status Verified: 2023-09
• Study Start: 2023-11-15
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pads with cold magnesium sulfate 33% solution	Magnesium sulfate 33% solution	-
Pads with cold water	Cold water	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Baruch Padeh Medical center, Poriya; 🇮🇱 Tiberias, North, Israel