Vaginal Progesterone for the Prevention of Preterm Birth in Twins: A Pilot Randomised, Factorial Designed Trial (POPPET)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- The median gestational age (in days) at delivery
研究概览
简要总结
This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.
详细描述
Randomised studies in singleton pregnancies suggest that the risk of preterm birth can be decreased by using of progesterone. However, in twin pregnancies, no significant reduction in preterm birth has been demonstrated in any trial.
One explanation for the lack of benefit of progesterone in previous twin studies may result from a suboptimal dosage. The investigators therefore hypothesize that progesterone dosages that are sufficient for singleton pregnancies are insufficient for twins and this is likely to be one of the reasons why prophylactic progesterone has failed to reduce preterm birth in twins.
Another possible explanation for the negative findings in previous twin studies may result from administration beginning too late in the second-trimester. It is thought that the mechanism of preterm birth in twin pregnancies is more strongly related to exaggerated uterine distension, which may override any benefit of progesterone on the cervix after a threshold has been reached. It is also plausible that cervical shortening occurs earlier in twin pregnancies than with singletons, and that treatment is required before a threshold of shortening is reached or before any inflammation-mediated component to the initiation of preterm birth has been established as the biological mechanisms by which preterm birth occurs differ from those in singleton pregnancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Age > 18 years
- •Dichorionic diamniotic (DCDA) pregnancies
- •Live fetuses at 11-13 weeks of gestation,
- •Informed and written consent
排除标准
- •High-risk for aneuploidies,
- •Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks or 20-24 weeks assessment,
- •Hypersensitivity to progesterone,
- •Women taking progesterone regularly or at any time within the previous 7 days,
- •Concurrent participation in another drug trial or at any time within the previous 28 days,
- •Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness,
- •Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
研究组 & 干预措施
Early Low-dose Arm
Start from 11-14 week: 200 mg self-administered vaginal progesterone daily
干预措施: Progesterone (Drug)
Early High-dose Arm
Start from 11-14 week: 400 mg self-administered vaginal progesterone daily
干预措施: Progesterone (Drug)
Late Low-dose Arm
Start from 20-24 week: 200 mg self-administered vaginal progesterone daily
干预措施: Progesterone (Drug)
Late High-dose Arm
Start from 20-24 week: 400 mg self-administered vaginal progesterone daily
干预措施: Progesterone (Drug)
结局指标
主要结局
The median gestational age (in days) at delivery
时间窗: At delivery
次要结局
- Birth weight(At delivery)
- The incidence of spontaneous preterm birth(Less than 34 weeks (237 days) of gestation)
- Stillbirth or neonatal death due to any cause(At delivery)
- Major adverse outcomes before discharge from the hospital(Within the first year)
- Need for neonatal special care(Between birth and 28 days of age)
研究者
Chiu Yee Liona Poon
Associate Professor (Clinical)
Chinese University of Hong Kong