Clinical trial

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.

Name
112-19
Description
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.
Trial arms
Trial start
2023-11-15
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Magnesium sulfate 33% solution
Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
Arms:
Pads with cold magnesium sulfate 33% solution
Cold water
Topical pads with cold water will be given 5 times/day for 15 minutes
Arms:
Pads with cold water
Size
140
Primary endpoint
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
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}
Updated at
2023-11-21

1 organization

1 product

1 indication