E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
This is a feasibility study. The primary objective is to determine the feasibility of conducting a randomised controlled trial of Prostaglandin pessary versus trans-cervical balloon catheter for out-patient induction of labour.
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E.2.2 | Secondary objectives of the trial |
The secondary aim is to assess women’s experience with these methods and their preference and to assess the clinical efficacy, cost effectiveness and safety of trans-cervical balloon catheter compared to Prostaglandins for out-patient induction of labour in low-risk women.
Logistic issues of Propess and balloon catheter induction, and possible problems with them would come to light only after a feasibility trial has been conducted.
Data will also be gathered on clinical outcomes including mode of birth, rate of labour and birth complications, admissions to NNU, maternal and infant morbidity and on women's experiences of induction using the different methods. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Pregnant women aged 18 years or over with a single fetus and uncomplicated pregnancy, who were at a Gestational age > 37 completed weeks, needing induction of labour. 2. No medical risk factors. 3. Able to provide informed consent |
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E.4 | Principal exclusion criteria |
1. Unsuitable for outpatient management 2. Unsuitable for randomisation to either PGE2 (e.g. previous Caesarean section/hypersensitivity to Prostaglandins) or catheter use (e.g. latex allergy), or prior attempted IOL in this pregnancy. 3. Had ruptured membranes, or evidence of regular uterine contractions at time of booked induction. 4. Multiple pregnancy or non-vertex presentation; 5. Placenta praevia. 6. Lethal fetal congenital anomaly. 7. Non-vertex presentation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of eligible women willing to be randomised to Propess or balloon catheter in an outpatient setting. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of 12 month Recruitment period |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 2 |
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
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Last patient last data collection point |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 28 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |