NCT04052347终止不适用
Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks: A Randomized Trial (DAWN Trial)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
研究概览
简要总结
The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low-risk nulliparous women- no previous pregnancy > 23 weeks
- •18-50 years of age
- •Singleton gestation
- •Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.
排除标准
- •First sonographic examination after 20 weeks
- •Women with any of the following comorbidities (at the time of randomization):
- •Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)
- •Cerclage in the index pregnancy
- •Diabetes mellitus-gestational or pre-gestational
- •Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)
- •Hypertension (chronic or pregnancy induced) before enrollment
- •HIV (human immunodeficiency virus)
- •Institutionalized individuals (prisoners)
- •Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death
- •Preterm labor or ruptured membranes before enrollment
- •Psychiatric disorder (bipolar, depression) on medication
- •Placenta previa / 3rd trimester bleeding
- •Renal insufficiency (serum creatinine > 1.5 mg/dL)
- •Restrictive lung disease
- •Fetal red blood cell isoimmunization
- •Seizure disorder on medication
- •Thyroid disease on medication
- •Body Mass Index (BMI) above 40 kg/m
- •Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects
- •Unable to understand consent in English or Spanish
结局指标
主要结局
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
时间窗: 4 weeks
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
次要结局
- Maternal morbidities(1 week)
- Composite neonatal morbidity(at delivery)
研究者
Sunbola S Ashimi Ademola
Senior Researcher
The University of Texas Health Science Center, Houston
研究点 (2)
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