The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Incidence of spontaneous preterm birth - before 37 weeks.
研究概览
简要总结
Working hypothesis and aims:
To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.
The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Viable pregnancy
- •Gestational age between 13 to 26 weeks
- •Vaginal bleeding from uterine origin
- •Singleton pregnancy
- •Normal clotting tests
- •Hemodynamically stable woman
排除标准
- •Water leak
- •Signs of preterm labor
- •Fetal malformations incompatible with life
- •Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state
- •Past preterm birth
研究组 & 干预措施
Utrogestan
干预措施: micronized progesterone 200 mg (Utrogestan) (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of spontaneous preterm birth - before 37 weeks.
时间窗: 3 years
次要结局
- Maternal and fetal outcomes(3 years)
研究者
Raed Salim
Dr.
HaEmek Medical Center, Israel