A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women with a Previous Singleton Spontaneous Preterm Delivery - ND

Phase 1

• Conditions: Preterm birth; MedDRA version: 9.1Level: LLTClassification code 10036594

• Registration Number: EUCTR2009-014696-52-IT
• Lead Sponsor: HOLOGIC, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-29
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1707

Inclusion Criteria

1.Age ≥ 18 years.
2.Singleton gestation.
3.Project gestational age 160 weeks of gestation or more and less than or equal to 206 weeks of gestation at the time of randomization, based on clinical information and evaluation of the first ultrasound.
4.Documented history of a previous singleton spontaneous preterm delivery. Spontaneous preterm birth is defined as delivery from 200 to 366 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Multifetal gestation.
2.Known major fetal anomaly or fetal demise. An ultrasound examination between 140 through 203 weeks of gestation must be performed to rule out fetal anomalies.
3.Progesterone treatment in any form (i.e., vaginal, oral, intramuscular) during current pregnancy.
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 didelphus or bicornate uterus). However, subjects with uterine fibroids are eligible for the study.
7.Unwillingness to comply with and complete the study.
8.A 140 through 203 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 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 those listed in section 5.3.2 of the investigational brochure. 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 in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified