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NCT Number: NCT06126068

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

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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Key information

Conditions

Severe Pre-eclampsia Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, 480001, Nigeria

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Loading dose magnesium sulfate versus the Pritchard regimen

Primary outcomes

  1. Incidence of convulsions

    Time frame: During the intervention

    percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia

Secondary outcomes

  1. Drug toxicity

    Time frame: During the intervention

    number of neonatal asphyxia, respiratory depression, loss of tendon reflex and cardiac arrest.

Sponsors and collaborators

Lead sponsor

Federal Teaching Hospital Abakaliki

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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