Oral Nifedipine Versus IV Labetalol in Treatment of Severe Pre Eclampsia in Pregnancy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Time taken for Blood Pressure control
研究概览
简要总结
OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients
Design: Randomised control trial
SETTING: Department Obstetrics & gynaecology, Services Hospital, Services Institute of Medical Sciences. Lahore
POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia
METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful
详细描述
Gestational hypertension is associated with increased risk of maternal morbidity and mortality. Parenteral therapy needs more resources, more monitoring and supervision. Oral therapy is cheap, easily available, easy to administer especially in resource constrained settings
OBJECTIVE
To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients
Design: Randomised control trial SETTING: Department Obstetrics & gynaecology, Services Hospital, Services Institute of Medical Sciences.Lahore POPULATION: Pregnant patients with BP 160/110 mm Hg or symptoms of severe preeclampsia
METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age 24 to 41 weeks
- •BP > 160/110 mm Hg with proteinuria
- •Patients with S/S of imminent eclampsia as headache, visual disturbance.
排除标准
- •Gestational age < 24 wks
- •Non proteinuric chronic hypertension
- •Eclampsia
- •Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol
研究组 & 干预措施
Oral Nifedipine
Nifedipine 10mg oral tablet & 1ml 0.9%N/Saline will be given every 15 minutes up till one hour
干预措施: Nifedipine 10 mg (Drug)
IV Labetalol
IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour
干预措施: Labetalol (Drug)
结局指标
主要结局
Time taken for Blood Pressure control
时间窗: 60 minutes
Time taken to control Blood pressure will be measured
次要结局
- Neonatal Intensive Care Unit admission,(From Birth till 7 days)
- Fetal distress(Labour)
- perinatal death(From birth to 7 days)
研究者
Tayyiba Wasim
professor obs Gynecology
Services Institute of Medical Sciences, Pakistan