A Prospective, Single Center, Open-Label, Non-Comparative Study For Evaluation Of Efficacy And Safety Study Of Isoxsuprine Hydrochloride As Uterine Relaxant In Preterm Labor
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Percentage of patients with Isoxsuprine hydrochloride injection having successful tocolysis in first 24 hours.
研究概览
简要总结
This is a prospective, single center, open-label, non-comparative study designed to evaluate effectiveness and safety of Isoxsuprine hydrochloride as a uterine relaxant in preterm labor. The study population will include patients with preterm labor, admitted at the study site and are clinically indicated for the treatment with Isoxsuprine hydrochloride, as per the discretion of treating physician.
All study participants will be given a loading dose of intravenous infusion of Isoxsuprine hydrochloride four (4) ampoules (40 mg) in 500 ml of 5% dextrose giving a concentration of 0.8 mg/ml. Drop rate will be set at 8 drops/minute (0.04 mg/minute). The drop rate will be increased by 8 drops/minute after every 15-minutes until uterine quiescence is attained, or patient develops adverse effects like maternal tachycardia (heart rate >130/minute) or hypotension (systolic blood pressure <80 mmHg or diastolic blood pressure <40 mmHg), or intolerable nausea and vomiting or foetal tachycardia (foetal heart rate >160 beats/minute). The infusion will be discontinued if any adverse effect develops, otherwise, intravenous infusion will be continued over next 12 hours after uterine quiescence.
After 15 minutes of stoppage of infusion, intramuscular injection of Isoxsuprine hydrochloride 10 mg/ 4 hourly will be given up to first 24-hours of hospitalization. Subsequently, Isoxsuprine hydrochloride 40mg sustained release capsule will be prescribed twice daily as maintenance therapy for next 24-hours, and the patient will be kept on the same dose till the time of the delivery.
Treatment will be considered successful if the uterine quiescence was maintained for at least 48 hours. If the sign of preterm labor recurs, parenteral therapy as described above will be started. Adverse effects reported or observed will also be recorded. Treatment will be discontinued if the patient experiences intolerable side effects requiring discontinuation of the therapy. Otherwise, the patient will be prescribed Isoxsuprine hydrochloride 40mg sustained release capsule, twice daily as maintenance therapy till the time of delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Gestational age 24-37 weeks 2.Regular uterine contractions, 2 or more than 2 per 20 minutes each lasting for at least 20 seconds 3.Cervical dilatation less than 3 cm 4.Cervical effacement less than 50%.
- •5.Intact membrane.
排除标准
- •1.Antepartum hemorrhage 2.Fetal malformations 3.Pregnancy with heart disease and diabetes mellitus 4.Multiple pregnancies 5.Hydramnios 6.Prolonged PROM.
结局指标
主要结局
1.Percentage of patients with Isoxsuprine hydrochloride injection having successful tocolysis in first 24 hours.
时间窗: Baseline (0 Hour) | 24-Hours | 48-Hours | Time of delivery
2.Percentage of patients with Isoxsuprine hydrochloride Retard 40mg capsule having successful tocolysis in next 24 hours.
时间窗: Baseline (0 Hour) | 24-Hours | 48-Hours | Time of delivery
次要结局
- 1.Percentage of patients with adverse effects during first 24 hours of Isoxsuprine hydrochloride injection therapy.(2.Percentage of patients with adverse effects during maintenance therapy with Isoxsuprine hydrochloride Retard 40mg capsule.)