Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-08 @ 11:01 PM
Study NCT ID:
NCT04464005
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2020-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2020-07-05', 'studyFirstSubmitQcDate': '2020-07-05', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of women with perineal pain score< 3 NRS at the day after treatment initiation', 'timeFrame': '24 hours post enrollment'}, {'measure': 'Perineal pain intensity according to NRS scale at the day after treatment initiation', 'timeFrame': '24 hours post enrollment'}], 'secondaryOutcomes': [{'measure': 'Degree of perineal healing using the REEDA scale', 'timeFrame': '2 days'}, {'measure': 'Perineal pain intensity according to NRS scale two days after treatment initiation', 'timeFrame': '2 days (if still in hospital)'}, {'measure': 'Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Women After Delivery With Perineal Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nIn the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.\n\nWomen 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman after spontaneous or operative vaginal delivery\n* Perineal pain score of at least 2 NRS\n\nExclusion Criteria:\n\n* Women after cesarean delivery\n* Refuse to participate\n* Under 18 years of age\n* Magnesium sulfate treatment not related to the study\n* Contraindication for magnesium sulfate treatment\n* Workers of the local obstetric department'}, 'identificationModule': {'nctId': 'NCT04464005', 'briefTitle': 'Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Baruch Padeh Medical Center, Poriya'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '112-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pads with cold magnesium sulfate 33% solution', 'interventionNames': ['Drug: Magnesium sulfate 33% solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pads with cold water', 'interventionNames': ['Other: Cold water']}], 'interventions': [{'name': 'Magnesium sulfate 33% solution', 'type': 'DRUG', 'description': 'Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes', 'armGroupLabels': ['Pads with cold magnesium sulfate 33% solution']}, {'name': 'Cold water', 'type': 'OTHER', 'description': 'Topical pads with cold water will be given 5 times/day for 15 minutes', 'armGroupLabels': ['Pads with cold water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15208', 'city': 'Tiberias', 'state': 'North', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Enav Yefet, MD/PhD', 'role': 'CONTACT'}], 'facility': 'Baruch Padeh Medical center, Poriya', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}], 'centralContacts': [{'name': 'Enav Yefet, MD/PhD', 'role': 'CONTACT', 'email': 'enyefet@pmc.gov.il', 'phone': '972-46652306'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Baruch Padeh Medical Center, Poriya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}