E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pre-treatment during late pregnancy to reduce prolonged labour. |
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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 |
To evaluate the effect of pre-treatment with DF01 compared with placebo on labour delivery time, which is defined as time from cervical dilatation of at least 3 cm and 3 contractions of minimum one minute´s duration/10 minutes until partus in women with vaginal delivery. |
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E.2.2 | Secondary objectives of the trial |
To assess safety and tolerability of DF01, Complications of labour (e.g. caesarean section, instrumental delivery, vaginal tears, sphincter rupture, post-partum bleeding), Use of epidural anaesthesia, Foetal complications [e.g. cord artery pH < 7.10 and/or base deficit > 12 mmol/L , Apgar score < 7 at 5 minutes, neonatal intensive care unit (NICU) admission, neonatal diagnoses.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) Healthy nulliparous females, 18-40 years of age with the gestation age confirmed by ultrasound. b) Normal singleton pregnancy c) Intact membranes d) In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits. e) Subject is capable of understanding and signing an informed consent form.
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E.4 | Principal exclusion criteria |
a) Breech presentation including other abnormal presentations b) Vaginal bleeding in the last 10 weeks of the pregnancy c) Intercurrent illness (e.g. essential hypertension, diabetes, coagulation disorders) d) Pregnancy complications (e.g. hypertension in pregnancy, preeclampsia, hepatosis) e) Coagulation defects (prolonged APTT; Prothrombin complex (INR) > 1.2 ); Thrombocytes <130 x 109/L f) Infections (HIV, hepatitis, STDs) g) Suspected foetal malformation h) Suspected intrauterine growth retardation i) Hospitalized due to complication during the last 10 weeks of the pregnancy j) Any known history of allergy to heparin and/or dalteparin (Fragmin) k) Any known history of heparin-induced thrombocytopenia l) Fear of injections m) Body mass index (BMI) > 30 kg/m2.
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E.5 End points |
E.5.1 | Primary end point(s) |
Labour delivery time, defined as the time from cervical dilatation of at least 3cm and 3 contractions of minimum 1 minute´s duration/10 minutes until partus. |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
| 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 | 17 |
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 | Information not present in EudraCT |
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
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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 | 32 |
E.8.9.1 | In the Member State concerned days | |