E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preterm birth (less than or equal to 32 6/7 weeks gestation) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Reduction in the frequency of preterm birth (less than or equal to 32 6/7 weeks gestation) |
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E.2.2 | Secondary objectives of the trial |
Reduction in the frequency of neonatal morbidities such as respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), proven sepsis, and necrotizing enterocolitis (NEC);2) Reduction in the frequency of preterm birth at ≤27 6/7, ≤34 6/7, and <36 6/7 weeks gestation; 3)Reduction in the frequency of neonatal mortality;4) Reduction in the frequency of admission for preterm labor;5) Assessment of the admission-to-delivery interval in subjects receiving tocolytic therapy for preterm labor;6) Assessment if Apgar scores, length, weight, and head circumference at birth and incidence of congenital anomalies;7) Assessment of other indicators of neonatal morbidity such as admission to the NICU, the duration of stay in the NICU, and the total hospital stay.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The subject has a short cervical lenght by transvaginal ultrasound (TCVU) defined as 10-20 mm. In cases of "dynamic cervix", the shortest observed/documented cervical lenght by TVU is to be used as the cervical lenght for inclusion purposis.
2. Singleton gestation.
3. The pregnancy has a estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.
4. Maternal age between 15 (or local age of majority/emancipation) and 45 years od age at the time of screening. An alternative age range can be accepted according to the standards and applicable regulations of the study centers.
5. The subject speaks either English or a common local language.
6. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
7. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.
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E.4 | Principal exclusion criteria |
1. The subject has a cervical length <10 or >20 mm.
2. The subject has a multifetal gestation.
3. The subject has or is scheduled to have a cervical cerclage prior to randomization. According to ACOG Practice Bulletin Number 48 (November 2003), cerclage can be considered in a subject with a history of 3 or more unexplained midtrimester pregnancy losses or preterm deliveries.228,229
4. Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.
5. The subject has a previous of an adverse reaction to progesterone or any component present in Prochieve®/Crinone 8% vaginal gel.
6. The subject has been treated with a progestogen within the previous 4 weeks.
7. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).
8. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or a thromboembolic disorder.
9. The subject has active liver dysfunction or disease.
10. The subject has known or suspected malignancy of the breast or genital organs.
11. The subject is currently participating in another interventional study or has participated in an interventional drug study within one month prior to screening for this study.
12. The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
13. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus).
14. The subject, in the judgement of the investigator, will be unable or unwilling to comply with study-related assesments and procedures.
15. The subject currently has preterm rupture or membranes, vaginal bleeding. known o suspected amnionitis, or signs or symptoms or preterm labor at the time of enrollment.
16. The subject is HIV positive with a CD4 count of <350 cells/mm3 and is receiving more than one (1) medication to prevent the transfer of AIDS to the fetus.
17. Complete placenta previa.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with a delivery of less than or equal to 32 6/7 weeks gestational age |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |