NCT04464005

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

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Magnesium sulfate 33% solution	Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
OTHER	Cold water	Topical pads with cold water will be given 5 times/day for 15 minutes

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-07-09
• Last updated: 2023-11-21

Locations

1 site across 1 country: Israel