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

Baruch Padeh Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Women After Delivery With Perineal Pain

Treatments: Drug: Magnesium sulfate 33% solution; Other: Cold water

Study type: Interventional

Funder types: Other

Identifiers

NCT04464005

112-19

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Pads with cold magnesium sulfate 33% solution

Experimental group

Treatment:

Drug: Magnesium sulfate 33% solution

Pads with cold water

Placebo Comparator group

Treatment:

Other: Cold water