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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-06-30

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.

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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)

Conditions

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Severe Pre-eclampsia Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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first arm - Loading dose of magnesium sulfate

This arm received Loading dose of magnesium sulfate only. those that developed complication in each arm were managed according to departmental protocol.

Group Type ACTIVE_COMPARATOR

Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia

Intervention Type DRUG

Loading dose magnesium sulfate versus the Pritchard regimen

2. Pritchard regimen

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.

Group Type ACTIVE_COMPARATOR

Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia

Intervention Type DRUG

Loading dose magnesium sulfate versus the Pritchard regimen

Interventions

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Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia

Loading dose magnesium sulfate versus the Pritchard regimen

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No