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.
Verified date | November 2023 |
Source | Federal Teaching Hospital Abakaliki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Federal Teaching Hospital, Abakaliki | Abakaliki | Ebonyi |
Lead Sponsor | Collaborator |
---|---|
Federal Teaching Hospital Abakaliki |
Nigeria,
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 |
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