A Double Blinded Randomized Controlled Trial of Early Use of Oral Progesterone in All Women for Prevention of Preterm Delivery in Singleton Pregnancy (SINPRO Study)
试验速览
- 阶段
- 2 期
- 入组人数
- 1,714
- 试验地点
- 1
- 主要终点
- Rate of preterm delivery
研究概览
简要总结
Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities, and it is the second most common cause of death in children under the age of 5 year. Neonates born preterm are at risk of respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. It is estimated that the societal cost of PTB is $26 billion annually in the USA alone.
Until now, prevention or reduction of PTB is based on identification of risk factors in obstetrical history, biochemical markers and short cervix. History of PTB and asymptomatic short cervix at the second trimester are both strong predictors for PTB. In women with asymptomatic short cervix at the second trimester, vaginal progesterone could effectively reduce PTB. Universal cervical length screening followed by treatment with vaginal progesterone has been shown to be the most cost effective strategy in preventing PTB. These findings were confirmed in meta-analysis.
Nevertheless, only minority of women may benefit from progesterone treatment if it was being started at the second trimester. There is still a large proportion of PTB, which is currently not preventable, and the current approach to prevent PTB is far from ideal.
One possible hypothesis is that the initiation of progesterone treatment would be too late for its effect to take place. Therefore, we decide to use oral progesterone in the current study. The objective of the study is to determine whether early use of progesterone can prevent PTB better when compared with universal screening of cervical length and followed by treatment with progesterone in those with short cervix.
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
- 是
入选标准
- •All women age ≥ 18 years old
- •Confirmed intrauterine singleton pregnancy
- •Gestational age less than 14 completed weeks as defined by pelvic ultrasound
排除标准
- •Silent miscarriage: mean gestational sac diameter ≥25 mm without fetal pole, or embryo with crown rump length ≥7 mm and no heartbeat, or no interval growth
- •Suspected ectopic pregnancy
- •Multiple pregnancy with silent miscarriage of one twin
- •Heavy vaginal bleeding requiring surgical intervention
- •Severe abdominal pain requiring surgical intervention
- •Presence of fever
- •History of adverse reaction to progesterone
- •History of breast or genital tract malignancy
- •History of suspected thromboembolic disease
- •Congenital uterine anomaly
- •Unwillingness or inability to comply with study procedures
- •Known paternal or maternal abnormal karyotype
研究组 & 干预措施
Intervention group
干预措施: Dydrogesterone Oral Tablet (Drug)
Placebo group
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Rate of preterm delivery
时间窗: before 37+0 gestational weeks
次要结局
未报告次要终点
研究者
Dr. Cheung Ka Wang
Associate Consultant
The University of Hong Kong