Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 12
- 主要终点
- Proportion of deliveries before week 34 of gestation
研究概览
简要总结
Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged between 18 - 45 years
- •Gestational age between 24.0 and before 33.6 gestational weeks
- •Singleton pregnancy
- •Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
- •Ultrasound cervical length at discharge < 25 mm
- •Signed patient consent form (CI)
排除标准
- •Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
- •Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
- •With known allergy to progesterone or peanuts (excipient).
- •Grade 2 (or upper) renal or liver laboratory abnormalities
- •Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
- •With Diabetes mellitus or insulinized gestational diabetes
- •Treated with heparin
- •Drug abuse
- •Inadequate treatment compliance
研究组 & 干预措施
B
Placebo
干预措施: Placebo (Drug)
A
Progesterone 200 mg
干预措施: Progesterone (Drug)
结局指标
主要结局
Proportion of deliveries before week 34 of gestation
时间窗: week 34 of gestation
次要结局
- Ultrasound cervical length(week +5)
- Median time from randomization to delivery(delivery)
研究者
Montse Palacio
MD, PhD
Hospital Clinic of Barcelona