E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000154 |
E.1.2 | Term | Abnormal labour affecting foetus |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054386 |
E.1.2 | Term | Fetal heart rate disorder |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046790 |
E.1.2 | Term | Uterine hypertonus |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013442 |
E.1.2 | Term | Disseminated intravascular coagulation |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046820 |
E.1.2 | Term | Uterine rupture |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002198 |
E.1.2 | Term | Anaphylactic reaction |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018162 |
E.1.2 | Term | Genital oedema female |
E.1.2 | System Organ Class | 100000004872 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001971 |
E.1.2 | Term | Amniotic fluid embolism |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028816 |
E.1.2 | Term | Nausea and vomiting |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012735 |
E.1.2 | Term | Diarrhoea |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016492 |
E.1.2 | Term | Fetal distress syndrome |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 the synthetic osmotic cervical dilator in cervical ripening, for IoL, in comparison to dinoprostone vaginal insert to successfully achieve vaginal delivery within 36 hours from randomisation. |
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E.2.2 | Secondary objectives of the trial |
To determine the response to a synthetic osmotic cervical dilator in cervical ripening, for IoL, in comparison to dinoprostone vaginal insert on maternal and neonatal outcomes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women must meet the following criteria prior to initiation of IoL: 1. ≥ 16 years of age 2. Able to provide informed consent 3. Singleton pregnancy 4. Indication for IoL 5. Pregnancy ≥ 37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan at 11-14 weeks) 6. Living fetus with vertex presentation 7. Intact membranes 8. Bishop Score (NICE Modified version July 2008) < 6 points
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E.4 | Principal exclusion criteria |
1. Women already receiving oxytocin 2. Diagnosis of fulminant preeclampsia / eclampsia 3. Contraindication to PROPESS or DILAPAN 4. If PROPESS for IoL is non-compliant with local policy 5. Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour
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E.5 End points |
E.5.1 | Primary end point(s) |
Failure to achieve vaginal delivery within 36 hours from randomisation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
36 hours after administration of Propess or Dilapan-S |
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E.5.2 | Secondary end point(s) |
To determine the response to a synthetic osmotic cervical dilator in cervical ripening, prior to induction of labour, in comparison to dinoprostone vaginal insert on successful vaginal delivery within 24 and 48 hours, caesarean section, gain in Bishop Score, maternal and neonatal outcomes, maternal satisfaction with cervical ripening, and maternal and neonatal infectious complications.
To understand the efficacy of a synthetic osmotic cervical dilator compared to dinoprostone vaginal insert we will stratify by: • randomising centre • nulliparous vs. multiparous • previous vaginal delivery vs. previous caesarean delivery • intention to manage inpatient vs. outpatient for IoL (according to the local maternity unit’s protocol) • Maternal obesity: BMI >= 30 kg/m2 vs. BMI < 30 kg/m2 at the first antenatal consultation • Maternal age: <20, 20-<30, 30-<40 vs. 40+ years
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-successful vaginal delivery within 24 and 48 hours: evaluated at 24 and 48 hours after administration of Propess/Dilapan-S -caesarean section: undertaken between administration of Propess/Dilapan-S and delivery of fetus. -gain in Bishop Score: compared at initiation of cervical ripening (i.e. administration of Propess/Dilapan-S) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first) -maternal and neonatal safety: SAEs recorded from administration of drug/device up to discharge, and resolution of SAE. -maternal satisfaction with cervical ripening: collected after delivery, prior to discharge. -fetal status after delivery: recorded on deliver |
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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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
DILAPAN-S (CE marked medical device) |
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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 | 5 |
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 | 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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The end of trial will be 90 days after the last woman has been discharged from their hospitalisation for IoL (the only exception to data being collected exclusively whilst the woman or her baby are in hospital, would be an ongoing SAE, which will be collected up to resolution of the event). This will allow sufficient time for the completion of protocol procedures, data collection, input and analyses. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |