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

NCT06126068 | Completed

• 1 other identifier: MSPL2023CT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Pre-eclampsia; Eclampsia

Keywords

Pre-eclampsia; Eclampsia; magnesium sulphate

Outcome Measures

Primary Outcomes (1)

• Incidence of convulsions

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

  During the intervention

Secondary Outcomes (1)

• Drug toxicity

  During the intervention

Study Arms (2)

first arm - Loading dose of magnesium sulfate

ACTIVE COMPARATOR

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

2. Pritchard regimen

ACTIVE COMPARATOR

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

Interventions

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

Loading dose magnesium sulfate versus the Pritchard regimen

2. Pritchard regimen; first arm - Loading dose of magnesium sulfate

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with severe preeclampsia
• Pregnant women with eclampsia
• Signing of informed consented to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, 480001, Nigeria

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)