A comparative study of Intravenous Labetalol and Intravenous Hydralazine for management of Severe hypertension in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effectiveness of the two intravenous drugs, Hydralazine and Labetalol, in the management of severe Hypertension in pregnancy with respect to lowering blood pressure
研究概览
简要总结
This study aims to compare Inj. Labetalol with Inj. Hydralazine in Severe hypertension in pregnancy and to observe the adverse effects of these drugs in pregnant women.
Group A- Receiving Inj. Labetalol and Group B - Receiving Inj. Hydralazine
Subjects received Labetalol 20 mg in 100ml NS infusion. Blood pressure will be measured after 5 min, and if either BP threshold is still found to be high (BP more than 160/110 mmHg), Inj. Labetalol 20 mg will be administered again slowly intravenously over 2 min. After 10 min, if BP is still higher than the threshold (above 160/110 mmhg), Inj. Labetalol 40 mg shall be administered in an escalating dose of Inj. Labetalol 80mg, with a maximum of 4 doses .Pulse and Bp to be recorded at 5min,10min,15min, 30 min, 1hr, 2hr, 3hr 4hr, 5hr and 6 hours .The regimen can be continued or changed after 6 hours or if blood pressure does not reduce earlier.
Hydralazine 5 mg shall be administered slowly intravenously over 5 min. Monitor vitals for 5 min, 10 min, 15 min, 20 min .If the blood pressure does not settle, after 20 min, repeat 5 mg of Inj Hydralazine over 5 min .Monitor vitals for 5 min, 10 min, 15 min, 20 min .Repeat the same with a maximum of 4 doses. Monitor vitals for at 5min,10min,15min, 30 min, 1hr, 2hr,3hr, 4hr, 5hr and 6hr.The regimen can be continued or changed after 6 hours or if blood pressure does not reduce or earlier.
Throughout the entire process, fetal heart rate will be monitored. If any abnormal fetal heart rate or compromised maternal condition is detected, the trial will be discontinued, and appropriate treatment shall be administered by the treating doctor.
This study is being done to find the effectiveness of the two intravenous drugs, Hydralazine and Labetalol, in the management of severe Hypertension in pregnancy with respect to lowering blood pressure, and the maternal outcomes with Inj. Hydralazine and Inj. Labetalol with respect to heart rate, BP, any adverse outcome and need for additional antihypertensive therapy. Other adverse outcomes with respect to the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All consenting pregnant women of age more than or equal to 18 years with systolic blood pressure more than or equal to 160 mmHg or Diastolic blood pressure (DBP) more than or equal to 110 mmHg like gestational Hypertension, preeclampsia, chronic Hypertension, chronic Hypertension with superimposed preeclampsia , with gestational period above 28 weeks.
排除标准
- •1.Multiple pregnancies 2.Women with known allergy to Hydralazine or Labetalol.
- •3.Women with idiopathic systemic lupus erythematosus or related diseases.
- •4.Women with myocardial insufficiency due to mechanical obstruction (ex-aortic or mitral stenosis or constrictive pericarditis).
- •5.Women with isolated right ventricular heart failure due to pulmonary Hypertension (cor pulmonale).
- •6.Women with dissecting aortic aneurysm.
- •7.Intrauterine death.
结局指标
主要结局
The effectiveness of the two intravenous drugs, Hydralazine and Labetalol, in the management of severe Hypertension in pregnancy with respect to lowering blood pressure
时间窗: 5min 10min 15min 30 min 1hr 2hr 3hr 4hr 5 hr and 6 hours
次要结局
- The maternal outcomes with Inj Hydralazine and Inj Labetolol with respect to heart rate, BP, any adverse outcome and need for additional antihypertensive therapy.(5min 10min 15min 30 min 1hr 2hr 3hr 4hr 5 hr and 6 hours)
- Other adverse outcomes with respect to the drug.(24 HRS)
研究者
DR SOUMYA DANDIN
BLDE(DU) Shri B M Patil Medical College, Hospital, and Research Institute , Vijayapura