Low Dose Magnesium Sulphate Versus Standard Pritchard Regimen In Management Of Severe Preeclampsia/Eclampsia

NCT04501289 | Completed

• 1 other identifier: FETHA/REC/VOL1/2017/482
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Background - Preeclampsia/eclampsia, a pregnancy specific multi-systemic disease, is associated with considerable maternal and perinatal morbidity and mortality. Prevention and/or treatment of convulsion with magnesium sulphate, among others, is life-saving. Despite different regimens that have been tried, the minimum effective dose of MgSO4 for the prevention of eclampsia in patients with preeclampsia and treatment of convulsion in those with eclampsia has not been determined. Objectives - To compare the maternal and perinatal outcomes and maternal side effects in eclamptic and preeclamptic participants treated with low dose regimen of MgSO4 with those treated with the Pritchard regimen. Materials and Methods - This will be a prospective, single blinded randomized controlled study of low dose versus Pritchard regimens of MgSO4. Participants will be randomly assigned to the either arm of the study. Efficacy and adverse effects of the drug on the mother and baby will be noted. Data will be collated, tabulated and then statistically analysed using the statistical package for social sciences (SPSS) Results - Conclusion will be drawn and recommendation made from the findings in the study.

Conditions

Preeclampsia/Eclampsia

Keywords

Preeclampsia; Eclampsia; Magnesium sulphate; Convulsion

Outcome Measures

Primary Outcomes (1)

• Convulsion

  Occurrence of convulsion for participants with severe preeclampsia and recurrence of convulsion for cohorts with eclampsia

  Within 24 hours of administration

Secondary Outcomes (8)

• Maternal side effects of MgSO4

  Within 24 hours of administration

• MgSO4 toxicity

  Within 24 hours of administration

• Respiratory depression

  Within 24 hours of administration

• Maternal complication 1

  Before delivery of baby

• Maternal complication 2

  Within 24 hours of delivery

Study Arms (2)

Low dose magnesium sulphate

EXPERIMENTAL

Experimental - participants in this arm will be pregnant women with severe preeclampsia/eclampsia who will receive low dose magnesium sulphate

Drug: Low dose magnesium sulphate

Magnesium sulphate Pritchard regimen

EXPERIMENTAL

Experimental - participants in this arm will be pregnant women with severe preeclampsia/eclampsia who will receive Pritchard regimen of magnesium sulphate

Drug: Pritchard regimen

Interventions

Low dose magnesium sulphate DRUG

Participants in this arm will receive 4g of 20% intravenous (I.V.) MgSO4 (Magphate®) given over 10 minutes, followed by 3g of 50% intramuscular (I.M.) MgSO4 in each buttock statim. Then, maintenance doses will be given as 2.5g of 50% MgSO4 administered intramuscularly 4 hourly for 24 hours, for participants with severe preeclampsia and for 24 hours post delivery or post last seizure episode, whichever occurs last, for cohorts with eclampsia.

Low dose magnesium sulphate

Pritchard regimen DRUG

Participants in this arm will receive loading dose as 4g of 20% MgSO4 I.V. over 10 minutes, followed by 5g of 50% MgSO4 I.M. in each buttock. Maintenance doses will be given as 5g of 50% MgSO4 I.M. 4 hourly in alternate buttock until 24 hours for patients with eclampsia and for 24 hours after delivery or after last fit, whichever occurs later, for cohorts with eclampsia.

Magnesium sulphate Pritchard regimen

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women with gestational age of 28 weeks and above
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with diagnosis of severe preeclampsia/eclampsia

You may not qualify if:

• Administration of MgSO4 before admission.
• Administration of diazepam or phenytoin before admission
• Maternal complications such as disseminated intravascular coagulation, cerebrovascular accident, renal disease, HELLP syndrome and aspiration pneumonitis.
• Multiple gestation
• Gestational ages below 28 weeks
• Postpartum eclampsia

Sponsors & Collaborators

• Adebayo Joshua Adeniyi: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Abakaliki LG, Nigeria

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; Seizures

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Joshua A Adebayo, MB;BS; FWACS

  Alex Ekwueme Federal University Teaching Hospital, Abakaliki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be informed of the drug to be administered and the duration but were unaware of the dosage of the drug to be administered to them. However, the investigator knew the dosage each study cohort received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Consultant, Department of Obstetrics and Gynaecology, Principal Investigator

Model Details: The participants in the study will be randomized into two study groups in ratio 1:1. Participants in group 1 will receive 4g of 20% intravenous (I.V.) MgSO4, followed by 3g of 50% intramuscular (I.M.) MgSO4 in each buttock statim. Then, maintenance doses will be given as 2.5g of 50% MgSO4 I.M. 4 hourly for 24 hours, for patients with severe preeclampsia and for 24 hours post-delivery or post last seizure episode, for patients with eclampsia; while those in group 2 will receive loading dose as 4g of 20% MgSO4 I.V., followed by 5g of 50% MgSO4 I.M. in each buttock. Maintenance doses will be given as 5g of 50% MgSO4 I.M. 4 hourly in alternate buttock until 24 hours for participants with eclampsia and for 24 hours after delivery or after last fit, whichever occurs later, for those with eclampsia

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 6, 2020
• Study Start: May 8, 2017
• Primary Completion: December 27, 2017
• Study Completion: January 22, 2018
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 20 years

Locations

NG (1)