study is designed to determine the efficacy of Hydroxyprogesterone Caproate Injection , 250mg/ml versus vehicle for the prevention of preterm birth in women who previously experienced spontaneous preterm delivery.
- Conditions
- Preterm birthMedDRA version: 19.0Level: LLTClassification code 10036594Term: Premature birthSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2009-014696-52-BG
- Lead Sponsor
- AMAG Pharma USA, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1707
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”
below.
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
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
medication
3.2. Subjects received hydroxyprogesterone
caproate
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method