NCT00343265已完成不适用
Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Gestational age
研究概览
简要总结
The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.
详细描述
Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed multiple pregnancy
- •Ultrasound confirmed minimum of 2 live fetuses
- •Gestational age 16-20 6/7 weeks
排除标准
- •Placenta previa
- •Pre-existing hypertension
- •Major fetal anomaly
- •Monoamniotic, monozygotic multiples
- •Maternal seizure disorder
- •History of, or active, thromboembolic disease
- •Maternal live disease
- •Breast malignancy or pathology
- •Progesterone dependent neoplasia
- •Plans to move to another city during pregnancy
- •Sensitivity to progesterone
- •Participation in other clinical trials during the pregnancy
研究组 & 干预措施
1
Active Comparator
Progesterone gel
干预措施: Vaginal progesterone gel (Drug)
2
Placebo Comparator
Vaginal gel with no medication
干预措施: Placebo gel (Drug)
结局指标
主要结局
Gestational age
时间窗: Delivery
次要结局
- Proportion of women delivering < 35 weeks(Delivery)
- Proportion of women delivering < 37 weeks(Delivery)
- Proportion of women having spontaneous preterm delivery(Delivery)
- Proportion of women having tocolytic therapy(During pregnancy)
- Treatment compliance(Delivery)
- Length of stay for mother and infants(Discharge)
- Infant morbidity and mortality(Discharge)
- Birth weight(Birth)
研究者
Dr. Sue Ross
Adjunct Professor
University of Calgary
研究点 (1)
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