Clinical trial NCT06126068: Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Pre-eclampsia
Eclampsia
Keywords: Pre-eclampsia
Eclampsia
magnesium sulphate
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2023-11-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of convulsions
timeFrame: During the intervention
Secondary outcomes:
measure: Drug toxicity
timeFrame: During the intervention
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Federal Teaching Hospital, Abakaliki
state: Ebonyi
Study officials:
References: