EUCTR2009-014696-52-BG进行中（未招募）1 期
A PHASE 3B, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF HYDROXYPROGESTERONE CAPROATE INJECTION, 250 MG/ML, VERSUS VEHICLE FORTHE PREVENTION OF PRETERM BIRTH IN WOMEN WITH A PREVIOUS SINGLETON SPONTANEOUS PRETERM DELIVERY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,707
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Each subject must meet the following criteria to be enrolled in this study:
- •1. Age = 18 years.
- •2. Singleton gestation.
- •3. Project gestational age 16 weeks of gestation or more and less than or equal to 20 weeks of gestation at the time of randomization, based on clinical information and evaluation of the first ultrasound, as described in Gestational Age Determination”
- •4. Documented history of a previous singleton spontaneous preterm delivery. Spontaneous preterm birth is
- •defined as delivery from 20 to 36 weeks of gestation following spontaneous preterm labor or pPROM. Where possible, the gestational age of the previous preterm birth (referred to as the qualifying delivery) should be determined as described in Gestational Age Determination” below. If the gestational age at delivery is obtained
- •directly from the medical record and more than one gestational age appears, the latest will be used. As a validation of the gestational age of the previous delivery, if the infant weighed more than 3300 grams (the birth weight 90th percentile for 36 weeks gestational age), this will not qualify as preterm. The previous preterm
- •delivery cannot be an antepartum stillbirth.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1707
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Multifetal gestation.
- •2. Known major fetal anomaly or fetal demise. An ultrasound examination between
- •14 through 20 weeks of gestation must be performed to rule out fetal anomalies.
- •3. Subjects who have received a progestin during the
- •current pregnancy AND meet one of the following
- •criteria are excluded.
- •3.1. The progestin was administered in the 4
- •weeks preceding the first dose of study
- •3.2. Subjects received hydroxyprogesterone
- •3.3. The progestin was administered by a route
- •other than oral or intra-vaginal.
- •4. Heparin therapy during current pregnancy or history of thromboembolic disease.
- •5. Maternal medical/obstetrical complications including:
- •– Current or planned cerclage
- •– Hypertension requiring medication
- •– Seizure disorder
- •6. Subjects with a uterine anomaly (uterine didelphys or bicornate uterus). However,
- •subjects with uterine fibroids are eligible for the study.
- •7. Unwillingness to comply with and complete the study.
- •8. A 14 through 20 weeks of gestation ultrasound cannot be arranged before
- •randomization.
- •9. Participation in an antenatal study in which the clinical status or intervention may
- •influence gestational age at delivery.
- •10. Participation in this trial in a previous pregnancy. Women who were screened in a
- •previous pregnancy, but not randomized, do not have to be excluded.
- •11. Known hypersensitivity to hydroxyprogesterone caproate injection or its components.
- •12. Have any significant medical disorder that, in the opinion of the investigator, would be a contraindication to
- •the use of the drug including the following list from section 5.3.2 of the investigational brochure:
- •Current or history of thrombosis or thromboembolic disorders
- •Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions
- •Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- •Cholestatic jaundice of pregnancy
- •Liver tumors, benign or malignant, or active liver disease
- •Uncontrolled hypertension
- •Other examples to consider include uncontrolled diabetes, known HIV infection or renal dysfunction.
- •13. Have any significant medical disorder that, in the opinion of the investigator, would preclude accurate
- •evaluation of the subjects condition or outcome or compromise the subjects safety in the study.
研究者
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