Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Preterm delivery (before completed 37th week of gestation)
研究概览
简要总结
The investigators study objective is to investigate the effectiveness of vaginal micronized progesterone in prolonging pregnancy after an episode of preterm labor which responded to tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions of progesterone supplementation by examining its effect on the two components of parturition: cervical ripening and myometrial contractility. The investigators will utilize transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal uterine EMG to assess the uterine muscle activity. The investigators will also look at the effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is expected to provide much more information.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with singleton pregnancies at gestational ages 25+0 to 33+6 weeks after an episode of preterm labor, with cervical length ≤25mm:
- •Patients presenting with signs and symptoms of preterm labor will be admitted and given the standard treatment for preterm labor, i.e. tocolysis for 48 hours, and antenatal steroids.
- •Those who will remain undelivered for 48 hours and will be found to have a cervical length of 25mm or less will be offered entrance into the study.
- •Preterm labor will be defined as at least 4 contractions in 30 minutes with cervical change assessed by digital cervical examination.
排除标准
- •Patients with preterm premature rupture of membranes (PPROM) will be excluded from the study, due to the possibility of ascending infection, as will those with suspected chorioamnionitis.
- •We will not include multiple pregnancies.
- •Patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.
研究组 & 干预措施
Progesterone
Patients in this arm will receive two micronized progesterone capsules (Utrogestan® 200 mg, i.e. 400 mg of micronized progesterone in sunflower oil) placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.
干预措施: Progesterone (Drug)
placebo
Patients will receive two placebo capsules placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.
干预措施: placebo vaginal capsules (Drug)
结局指标
主要结局
Preterm delivery (before completed 37th week of gestation)
时间窗: Assessed every 14 days until delivery or 36+6 weeks of gestation
次要结局
- Changes in uterine electromyographic (EMG) activity(Assessed every 14 days until delivery or 36+6 weeks of gestation)
- Cervical length changes(Assessed every 14 days until delivery or 36+6 weeks of gestation)
研究者
Ziva Novak Antolic
prof. dr. Ziva Novak Antolic, MD
University Medical Centre Ljubljana