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

NCT ID: NCT04464005

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-12-01

Brief Summary

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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

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Conditions

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Women After Delivery With Perineal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pads with cold magnesium sulfate 33% solution

Group Type EXPERIMENTAL

Magnesium sulfate 33% solution

Intervention Type DRUG

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

Pads with cold water

Group Type PLACEBO_COMPARATOR

Cold water

Intervention Type OTHER

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

Interventions

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Magnesium sulfate 33% solution

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

Intervention Type DRUG

Cold water

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baruch Padeh Medical center, Poriya

Tiberias, North, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Enav Yefet, MD/PhD

Role: CONTACT

972-46652306

Facility Contacts

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Enav Yefet, MD/PhD

Role: primary

Other Identifiers

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112-19

Identifier Type: -

Identifier Source: org_study_id

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