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

• Sponsor: Federal Teaching Hospital Abakaliki (Other)
• Overall Status: Completed
• CT.gov ID: NCT06126068
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Pre-eclampsia; Eclampsia	Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia	N/A

Detailed 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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jan 1, 2023
• Actual Primary Completion Date: Jun 30, 2023
• Actual Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia; Loading dose magnesium sulfate versus the Pritchard regimen
Active Comparator: 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.	Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia; Loading dose magnesium sulfate versus the Pritchard regimen

Outcome Measures

Primary Outcome Measures

1. Incidence of convulsions [During the intervention]

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

Secondary Outcome Measures

1. Drug toxicity [During the intervention]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal Teaching Hospital, Abakaliki	Abakaliki	Ebonyi	Nigeria	480001

Sponsors and Collaborators

• Federal Teaching Hospital Abakaliki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nwali Matthew Igwe, Principal Investigator, Federal Teaching Hospital Abakaliki
• ClinicalTrials.gov Identifier: NCT06126068
• Other Study ID Numbers: MSPL2023CT
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nwali Matthew Igwe, Principal Investigator, Federal Teaching Hospital Abakaliki: Pre-eclampsia; Eclampsia; magnesium sulphate
• Additional relevant MeSH terms: Pre-Eclampsia; Eclampsia; Magnesium Sulfate

Study Results

No Results Posted as of Nov 13, 2023