Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-25 @ 3:03 PM
Study NCT ID:
NCT06126068
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of convulsions', 'timeFrame': 'During the intervention', 'description': 'percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia'}], 'secondaryOutcomes': [{'measure': 'Drug toxicity', 'timeFrame': 'During the intervention', 'description': 'number of neonatal asphyxia, respiratory depression, loss of tendon reflex and cardiac arrest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-eclampsia', 'Eclampsia', 'magnesium sulphate'], 'conditions': ['Severe Pre-eclampsia', 'Eclampsia']}, 'descriptionModule': {'briefSummary': 'Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.\n\nTo compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in severe preeclampsia and recurrent fits in eclampsia in a low resource setting.\n\nA prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at the Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Sociodemographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted.', 'detailedDescription': 'Background: Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.\n\nObjectives: To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in patients with severe preeclampsia and recurrent fits in eclampsia in a low resource setting like ours.\n\nMethods: This was a prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at Alex Ekwueme Federal University Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Social demographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted. Data were collated, tabulated and analyzed using the statistical package for social sciences (SPSS) software (version 22, Chicago II, USA)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with severe preeclampsia\n* Pregnant women with eclampsia\n* Signing of informed consented to participate in the study.\n\nExclusion Criteria:\n\n* Refusal of consent,\n* Gestational age \\< 28 weeks\n* Received magnesium sulphate prior to presentation\n* mild preeclampsia\n* chronic hypertension in pregnancy\n* Medical or Obstetrical complication of pregnancy.'}, 'identificationModule': {'nctId': 'NCT06126068', 'briefTitle': 'Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Federal Teaching Hospital Abakaliki'}, 'officialTitle': 'Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia in a Resource Poor Setting, Southeast Nigeria.', 'orgStudyIdInfo': {'id': 'MSPL2023CT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'first arm - Loading dose of magnesium sulfate', 'description': 'This arm received Loading dose of magnesium sulfate only. those that developed complication in each arm were managed according to departmental protocol.', 'interventionNames': ['Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Pritchard regimen', 'description': 'This arm received the full dose of magnesium sulfate regimen by Pritchard. those that developed complication in each arm were managed according to departmental protocol also.', 'interventionNames': ['Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia']}], 'interventions': [{'name': 'Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia', 'type': 'DRUG', 'description': 'Loading dose magnesium sulfate versus the Pritchard regimen', 'armGroupLabels': ['2. Pritchard regimen', 'first arm - Loading dose of magnesium sulfate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '480001', 'city': 'Abakaliki', 'state': 'Ebonyi State', 'country': 'Nigeria', 'facility': 'Federal Teaching Hospital, Abakaliki', 'geoPoint': {'lat': 6.32485, 'lon': 8.11368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Teaching Hospital Abakaliki', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nwali Matthew Igwe', 'investigatorAffiliation': 'Federal Teaching Hospital Abakaliki'}}}}