E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaginal bleeding in the first 12 weeks of pregnancy. |
|
E.1.1.1 | Medical condition in easily understood language |
Vaginal bleeding in the first 12 weeks of pregnancy. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
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 |
To test the hypothesis that in women presenting with vaginal bleeding in the first trimester, progesterone (vaginal capsules 400mg twice daily), started as soon as possible after a scan has demonstrated a visible intrauterine gestation sac and continued to 16 completed weeks of gestation, compared with placebo, increases maternities with live births beyond 34 completed weeks by at least 5%. |
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E.2.2 | Secondary objectives of the trial |
To test the hypothesis that progesterone improves other pregnancy and neonatal outcomes such as gestation at delivery, viable pregnancy at 12 weeks, and survival at 28 days of neonatal life.
To test the hypothesis that progesterone is not associated with serious adverse effects to the mother or the neonate, including chromosomal and congenital abnormalities.
To explore the effects of progesterone in prognostic subgroups, including age, fetal heart activity, gestation at presentation, amount of bleeding and body mass index.
To explore the effect of progesterone on the use of healthcare resources such as antenatal, outpatient or emergency visits and inpatient admissions (nights in hospital, maternal admissions to high dependancy unit or intensive care unit, and neonatal admissions to special care baby unit or neonatal unit). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women presenting with vaginal bleeding in the first 12 weeks of pregnancy with an intrauterine gestation sac visible on ultrasonography. |
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E.4 | Principal exclusion criteria |
Women of age less than 18 years or ≥40; women with life-threatening bleeding; women already taking progesterone supplementation therapy; women with contraindications to progesterone use. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Live births beyond 34 completed weeks of gestation, as a proportion of all women randomised. |
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E.5.2 | Secondary end point(s) |
Gestation at delivery; ongoing pregnancy at 12 weeks (range 11 – 13 weeks) gestation, miscarriage rate, survival at 28 days of neonatal life, chromosomal and congenital abnormalities, and adverse events. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 23 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
The interventional phase of the trial will end when the last participant recruited has completed her last dose of trial treatment. The observational phase of the trial will cease when the 28-day follow-up has been completed for the baby of the last participant recruited. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 30 |