Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia in a Resource Poor Setting, Southeast Nigeria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of convulsions
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with severe preeclampsia
- •Pregnant women with eclampsia
- •Signing of informed consented to participate in the study.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia (Drug)
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.
干预措施: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia (Drug)
结局指标
主要结局
Incidence of convulsions
时间窗: During the intervention
percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia
次要结局
- Drug toxicity(During the intervention)
研究者
Nwali Matthew Igwe
Principal Investigator
Federal Teaching Hospital Abakaliki