The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Reduction in umbilical artery Doppler indices
研究概览
简要总结
Will follow up umblical artery Doppler indices for pregnancies with iugr taking placebo and oral isosorbide mononitrate to study its efficacy on the intrauterine growth restricted fetuses
详细描述
Patients meeting these criteria are to be randomized into one of the following two groups:
- Group A (n=23): The Isosorbide Mononitrate group: will receive (IMDUR®, 30 mg, tablet, AstraZeneca, Egypt) (Isosorbide-5-mononitrate Biphasic) twice daily for 4-6 weeks (according to xPharm: The Comprehensive Pharmacology Reference, 2007, Pages 1-4).
- Group B (n=23): The placebo group will receive (Osteocare®, tab, VITABIOTICS, Egypt) twice daily for 4-6 weeks Justification: Using PASS 11 program for sample size calculation, setting power at 80% and alpha error at 0.05 and according to "Trapani et al., 2015", the expected change in UTA-PI in isosorbide mononitrate group=21% compared to no change in placebo group. Sample size of 23 women per group will be needed to detect difference between two groups.
The study is to be double-blinded, where neither the researcher, nor the participants will know what type of medication each participant will receive, as a nurse will give each patient a closed envelope containing 21 tablets of one of the above two medications in a randomized fashion.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age : 18-34 BMI: 18-30 Singleton pregnancy Gestational age between 28-30 Criteria of IUGR
排除标准
- •Had known or suspected chromosomal or structural anomaly Had a condition which will require delivery Multiple pregnancy
研究组 & 干预措施
placebo group
Tablets twice daily for 4 weeks
干预措施: Placebo (Drug)
Isosorbid mononitrate group
Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks
干预措施: Isosorbid mononitrate (Drug)
结局指标
主要结局
Reduction in umbilical artery Doppler indices
时间窗: 4 weeks after initiation of treatment
Measuring of the umbilical artery Doppler resistant index (RI) with the patient in semi recombinant position, during a period of absent fetal movement and breathing. a minimum of three uniform Doppler waveforms will be measured
次要结局
- Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference(4 weeks after initiation of treatment)
- Development of fetal complications(4 weeks after initiation of treatment)
- Interval to delivery(37 weeks)
- Maternal side effects(4 weeks after initiation of treatment)
研究者
MayaAbdElRazek
Lecturer
Ain Shams University