Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT02024256
Status:
UNKNOWN
Last Update Posted:
2016-09-30
First Post:
2013-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2013-12-25', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the level of perineal pain', 'timeFrame': '3 days'}, {'measure': 'Reduction in perineal swelling', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Reduction in hemorrhoids pain and swelling', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vaginal delivery', 'Perineal swelling', 'Perineal pain', 'MgSo4', 'Magnesium sulfate', 'Cold water'], 'conditions': ['Vaginal Delivery', 'Perineal Swelling', 'Perineal Pain']}, 'referencesModule': {'references': [{'pmid': '33034900', 'type': 'DERIVED', 'citation': 'East CE, Dorward ED, Whale RE, Liu J. Local cooling for relieving pain from perineal trauma sustained during childbirth. Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery.\n\nAssessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Those patients who consent to participate in the trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in the study group will receive treatment with pads soaked in a cold aqueous solution of magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive treatment with pads soaked in cold water.\n\nNurses will initiate treatment according to the group to which the patient was randomized. Said pads will be given the patients routinely 5 times a day at regular times.\n\nA physician will assess the perineal swelling according to visual (photographed) scale in which severe, moderate, light and no swelling will be defined. Measurement of swelling in centimeters (maximal length and breadth); photography, by a medical photographer or the examining doctor, of the perineal area with a centimeter ruler, before, during and after treatment (photography is dependent on patient approval and is not a precondition to participation in the trial.); and additional examination, on the above basis, will be performed regarding hemorrhoids in the event that a patient has complained of such.\n\nA nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to the patient being given the pad and an hour following treatment. An additional assessment by the same method will be performed regarding hemorrhoid pain. Any analgesia administered will also be recorded.\n\nLikewise, for follow-up purposes a blood test for serum magnesium concentration will be taken before and after treatment.\n\nPeriod of follow-up will be 48-72 hours from childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parturients following normal vaginal birth or vacuum-assisted vaginal delivery\n* reporting of perineal pain equal to or greater than 3 on a 0-10 scale\n\nExclusion Criteria:\n\n* parturients following cesarean section\n* lack of consent to take part in the study\n* parturients interested in early discharge (within 48 hours of childbirth)\n* girls under 18 years of age'}, 'identificationModule': {'nctId': 'NCT02024256', 'acronym': 'MgSo4', 'briefTitle': 'Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Comparison Between Treatment With Gauze Soaked With Cold Magnesium Sulfate Solution Against Gauze Soaked With Cold Water for Treatment of Perineal Swelling Following Vaginal Delivery - A Double Blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'MG33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium sulfate', 'description': 'Pads soaked in cold magnesium sulfate solution', 'interventionNames': ['Other: Cold pads soaked in Magnesium sulfate solution']}, {'type': 'SHAM_COMPARATOR', 'label': 'Water', 'description': 'Pads soaked with cold water', 'interventionNames': ['Other: Cold pads soaked in water']}], 'interventions': [{'name': 'Cold pads soaked in Magnesium sulfate solution', 'type': 'OTHER', 'otherNames': ['Epson salt, MgSo4'], 'armGroupLabels': ['Magnesium sulfate']}, {'name': 'Cold pads soaked in water', 'type': 'OTHER', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Zohar Nahum, md', 'role': 'CONTACT', 'email': 'nachum_zo@clalit.org.il', 'phone': '97241584649'}, {'name': 'Irit Friedman', 'role': 'CONTACT', 'email': 'iritdavid@gmail.com, irit_da@clalit.org.il', 'phone': '972546202261'}, {'name': 'Zohar Nahum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HeEmek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Afula', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nahum Zohar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HaEmek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'centralContacts': [{'name': 'Zohar Nahum, MD', 'role': 'CONTACT', 'email': 'nachum_zo@clalit.org.il', 'phone': '97246494158'}, {'name': 'Irit Friedman, MA', 'role': 'CONTACT', 'email': 'iritdavid@gmail.com, irit_da@clalit.org.il', 'phone': '972546202261'}], 'overallOfficials': [{'name': 'Zohar Nahum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}