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

NCT04501289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-08-06

No results posted yet for this study

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

Interventions

DRUG

Low dose magnesium sulphate

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.

DRUG

Pritchard regimen

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.

Sponsors & Collaborators

  • Adebayo Joshua Adeniyi

    lead OTHER

Principal Investigators

  • Joshua A Adebayo, MB;BS; FWACS · Alex Ekwueme Federal University Teaching Hospital, Abakaliki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2017-12-27
Completion
2018-01-22

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501289 on ClinicalTrials.gov