NCT01846156已完成3 期
The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- duration of MgSo4 treatment
研究概览
简要总结
there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol
详细描述
The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.
The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-
- Systolic blood pressure ≥ 160.
- Diastolic blood pressure ≥ 110.
- Proteinuria > +2 by dip stick.
- Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).
- Fetal growth restriction (IUGR).
After obtaining an informed consent the patients will be subjected to the following:
- Careful history taking including age, parity, gestational age.
- Complete physical examination and assessment of the blood pressure.
- Urine analysis by dipstick.
- All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant females ≥20 weeks of gestation.
- •Pregnant females with criteria of severe pre-eclampsia.
- •Single or multi-fetal pregnancy.
- •Primigravida or Multigravida.
排除标准
- •Pregnant females < 20 weeks gestation.
- •Pregnant females with history of epilepsy.
- •Pregnant females with diabetes.
- •Pregnant females with chronic hypertension.
- •Pregnant females with renal disease.
研究组 & 干预措施
Abrreviated MgSO4 protocol
Experimental
- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
干预措施: MgSO4 (Drug)
No maintenance protocol
Experimental
- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate
干预措施: MgSO4 (Drug)
standard MgSO4 protocol
Active Comparator
- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
干预措施: MgSO4 (Drug)
结局指标
主要结局
duration of MgSo4 treatment
时间窗: 1 year
treatment duration
次要结局
- ICU admission(1 year)
研究者
Waleed El-khayat
Assistant Professor of Obstetrics & Gynecology
Cairo University
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Springfusor for Administration of Magnesium Sulphate in Preeclampsia and EclampsiaPreeclampsia and EclampsiaNCT03549767Makerere University241
已完成
4 期
Treatment Approaches to PreeclampsiaPreeclampsiaNCT01030627Gynuity Health Projects85
已完成
不适用
Abbreviated MgSO4 Therapy in Post-partum PreeclampsiaPregnancyPreeclampsiaNCT00344058Case Western Reserve University200
已完成
不适用
Serum Magnesium Concentration in Magnesium Sulfate Therapy for Severe PreeclampsiaSevere Pre-EclampsiaNCT05283473Mỹ Đức Hospital64
已完成
不适用
Low Dose Magnesium Sulphate Versus Standard Pritchard Regimen In Management Of Severe Preeclampsia/EclampsiaPreeclampsia/EclampsiaNCT04501289Adebayo Joshua Adeniyi114