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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06126068
Other study ID # MSPL2023CT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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