E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Premature uterine contractions premature labor |
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E.1.1.1 | Medical condition in easily understood language |
patients suffering from preterm labor or shortening of the cervix |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068718 |
E.1.2 | Term | Premature uterine contractions |
E.1.2 | System Organ Class | 100000004868 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036599 |
E.1.2 | Term | Premature labor |
E.1.2 | System Organ Class | 100000004868 |
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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 evaluate the efficacy of long term tocolysis with atosiban on the pregency outcome. (Gestational age at delivery) |
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E.2.2 | Secondary objectives of the trial |
Prolongation of pregnancy, time intervall til recurrant preterm labor, cervical length/shortening of the cervix, drop out rate
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
intact singleton pregnancy between 23+0 and 28+0 weeks gestation
intact membranes
cervical length ≤ 15mm
immediate previous completion of standard tocolysis with atosiban for 48 hours
Able to communicate well with the investigator, to understand and comply with the requirements of the study
Signed the written informed consent
women over 18 years |
|
E.4 | Principal exclusion criteria |
rupture of membranes Amnion infection syndrome, fever (>38°C) vaginal bleeding with intensity of menstruation or above placenta praevia polyhydramnion congenital malformations, deformations and chromosomal abnormalities preexistant Diabetes Typ I or II multiple pregnancies Prolaps of membranes till the external cervical os. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Does a long term tocolysis with atosiban lead to a prolongation of pregancy?
1.)Time ( in days) until recurrence of preterm labor with effect on the cervical length during the study period.
If 1 is significant: 2.) Time untill delivery during study period.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
recurrence of labor delivery |
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E.5.2 | Secondary end point(s) |
gestational age at birth
Time period (days) after long term tocolysis ( after the end of the study period) until birth
time period (days) after routine tocolysis (48hrs) until birth.
Time period (days) after the study period until recurrence of preterm labor with effect on the cervical length.
need for another tocolysis cycle after the study period until SSW 33+6.
Delivery before gestational age 28+0, 30+0, 33+6
Perinatal Mortality
Perinatal Morbidity- Perinatal Morbidity composite index
Side effects of the therapy (study period) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
recurrence of preterm labor and delivery |
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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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
End of the trial is reached as soon as the last subject had delivered the baby/ babies. |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |