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

Eclampsia Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06126068
• Other study ID #: MSPL2023CT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Federal Teaching Hospital Abakaliki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Severe Pre-eclampsia

Intervention

Drug:
• Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia
Loading dose magnesium sulfate versus the Pritchard regimen

Locations

Country	Name	City	State
Nigeria	Federal Teaching Hospital, Abakaliki	Abakaliki	Ebonyi

Sponsors (1)

Lead Sponsor	Collaborator
Federal Teaching Hospital Abakaliki

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of convulsions	percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia	During the intervention
Secondary	Drug toxicity	number of neonatal asphyxia, respiratory depression, loss of tendon reflex and cardiac arrest.	During the intervention