Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT03549767
Status:
UNKNOWN
Last Update Posted:
2018-06-08
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is testing the acceptability of the device (springfusor) in the administration of magnesium suphate'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 241}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Springfusor', 'timeFrame': 'At 24 hours after loading dose', 'description': 'Acceptability of Springfusor for administration of magnesium sulphate will be assessed using a Likert scale ranging from one (very acceptable) to five (very unacceptable).'}], 'secondaryOutcomes': [{'measure': 'Discontinuation', 'timeFrame': '24 hour after the loading dose', 'description': 'assessed as study participants who do not completed doses of magnesium sulphate'}, {'measure': 'Level of pain', 'timeFrame': 'At 24 hours after loading dose', 'description': 'The study participants will be asked to assess the severity of pain during the administration of magnesium sulphate using Visual analogue scale 1-7.'}, {'measure': 'Safety of springfusor', 'timeFrame': 'within 24 hours', 'description': 'Occurrence of respiratory depression eg rate \\<16/min'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia and Eclampsia']}, 'referencesModule': {'references': [{'pmid': '37815037', 'type': 'DERIVED', 'citation': 'Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Magnesium Sulphate is the drug of choice for prevention and treatment of seizures in preeclampsia and eclampsia. It is administered parenterally by intravenous (IV) and or intramuscular (IM) routes. The IM regimen requires repeated painful injections which may be a barrier to optimal utilization whereby, there is frequent omission of some doses or increased interval between maintenance doses and low patient acceptability of magnesium. The study plans to assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia.', 'detailedDescription': 'The IM regimen used in low resource settings, requires repeated painful injections which may be a barrier to optimal utilization whereby, there is frequent omission of some doses or increased interval between maintenance doses and low patient acceptability of magnesium. The study plans to assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia.\n\nIt is open label clinical randomized trail conducted at Mulago national referral and teaching hospital, where, 482 women diagnosed with preeclampsia and eclampsia will be randomized in blocks to either Springfusor device or standard of care for the administration of magnesium sulphate.\n\nWomen in the Springfusor group will have their loading dose (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 20 minutes) and maintenance therapy (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 4 hours. The 4 gm maintenance dose will be repeated every 4 hours for 24 hours) of Magnesium sulphate through an IV infusion administered using a Springfusor pump.\n\nThe control group will have Magnesium sulphate administered according to the Pritchard regimen (standard hospital practice). The Pritchard regimen involves administration of loading dose of 4 gm of 20% Magnesium sulphate IV over 15-20 minutes, immediately followed by 10 gm of 50% Magnesium sulphate IM (5gm on each buttock). The maintenance dose of 5 gm of 50% Magnesium sulphate IM every 4 hourly in alternate buttocks continued for 24 hours.\n\nThe primary outcome is the acceptability of administration of Magnesium sulphate using Springfusor assessed using a Likert scale. The other outcomes are discontinuation and complications in the two arms. Analysis will be intention to treat.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The study will include pregnant women with age of 15 years and above\n2. Pregnancy of 20+ weeks of gestation or delivered within 24 hours,\n3. Presenting with preeclampsia and eclampsia i.e. have a raised blood pressure (systolic of \\>140 mmHg and diastolic \\> 90mmHg), proteinuria \\>1+.\n4. Presenting within the study period\n5. Consent to participate in the study.\n\nExclusion Criteria:\n\n1. Pregnant women or delivered within 24 hours who admitted with had received magnesium sulphate 24 hours prior to admission,\n2. Has known allergy to magnesium sulphate and\n3. Has elevated serum creatinine (\\>1.2 mg/dl). However the participants may be enrolled prior to the knowledge of serum creatinine, but withdrawn if the level is \\>1.2 mg/dl.'}, 'identificationModule': {'nctId': 'NCT03549767', 'briefTitle': 'Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Randomized Trial to Compare Magnesium Sulphate Administration for Preeclampsia and Eclampsia: Springfusor Versus Standard of Approach', 'orgStudyIdInfo': {'id': 'REC 2018-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Springfusor', 'description': 'Women in this group will have their loading dose (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 20 minutes) and maintenance therapy (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 4 hours through an IV infusion administered using a Springfusor pump.. The 4 gm maintenance dose will be repeated every 4 hours for 24 hours.', 'interventionNames': ['Device: Springfusor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'The control group will have Magnesium sulphate administered using the Pritchard regimen, which involves administration of loading dose of 4 gm of 20% Magnesium sulphate IV over 15-20 minutes, immediately followed by 10 gm of 50% Magnesium sulphate IM (5gm on each buttock). The maintenance dose of 5 gm of 50% Magnesium sulphate IM every 4 hourly in alternate buttocks continued for 24 hours', 'interventionNames': ['Procedure: Standard of care']}], 'interventions': [{'name': 'Springfusor', 'type': 'DEVICE', 'description': 'Springfusor for administration of magnesium sulphate', 'armGroupLabels': ['Springfusor']}, {'name': 'Standard of care', 'type': 'PROCEDURE', 'description': 'Pritchard regimen. Magnesium sulphate is administered using hospital practice', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+256', 'city': 'Kampala', 'state': 'Central Region', 'country': 'Uganda', 'contacts': [{'name': 'Sam Ononge, Phd', 'role': 'CONTACT', 'email': 'ononge2006@yahoo.com', 'phone': '+256772486301'}, {'name': 'Sam Ononge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mualgo Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Sam Ononge, PhD', 'role': 'CONTACT', 'email': 'ononge2006@yahoo.com', 'phone': '+256772486301'}, {'name': 'Annettee Nakimuli, PhD', 'role': 'CONTACT', 'email': 'annettee.nakimuli@gmail.com', 'phone': '+256772471618'}], 'overallOfficials': [{'name': 'Sam Ononge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University College of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}