Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia.

Study Overview
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Brief Summary
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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. To 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. A 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.

Detailed Description
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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. Objectives: 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. Methods: 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)

Official Title
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Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia in a Resource Poor Setting, Southeast Nigeria.

Conditions
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Severe Pre-eclampsia, Eclampsia

Intervention / Treatment
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* Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with severe preeclampsia Pregnant women with eclampsia Signing of informed consented to participate in the study. Exclusion Criteria: Refusal of consent, Gestational age < 28 weeks Received magnesium sulphate prior to presentation mild preeclampsia chronic hypertension in pregnancy Medical or Obstetrical complication of pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: first arm - Loading dose of magnesium sulfate<br>This arm received Loading dose of magnesium sulfate only. those that developed complication in each arm were managed according to departmental protocol. | Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia<br>* Loading dose magnesium sulfate versus the Pritchard regimen<br>|
| Active Comparator: 2. Pritchard regimen<br>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. | Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia<br>* Loading dose magnesium sulfate versus the Pritchard regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of convulsions | percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia | During the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug toxicity | number of neonatal asphyxia, respiratory depression, loss of tendon reflex and cardiac arrest. | During the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-eclampsia, Eclampsia, magnesium sulphate