E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Syntocinon is used for labour induction to stimulate contractions. The current recommendation is to stimulate until delivery. We hypothesize that discontinuation of Syntocinon when the active phase of labour is established will reduce risk of harm of both mother and child and labour will progress. |
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E.1.1.1 | Medical condition in easily understood language |
The current recommendation is to stimulate contractions with Syntocinon until delivery if necessary. Discontinuation earlier in the labour proces may reduce risk of harm of both mother and child. |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062462 |
E.1.2 | Term | Labor stimulation |
E.1.2 | System Organ Class | 100000004865 |
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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 | 10023540 |
E.1.2 | Term | Labor induced |
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 |
The proposed study will investigate the effect of Syntocinon® to induce labour. The hypothesis to be studied is that once labour is established and the active phase of labour has commenced, Syntocinon® can be discontinued and the labour process will continue. The primary outcome will be the rate of caesarean delivery. The main secondary outcomes will be the duration of labour, neonatal conditions, maternal outcomes and satisfaction |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin and a cervical dilatation of ≤ 4cm). |
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E.4 | Principal exclusion criteria |
<18 years Unable to read and understand the Danish language or to give informed consent Non-cephalic presentation Multiple gestation Pathological fetal heart rate pattern (cardiotocogram, CTG) before Syntocinon® initiation Fetal weight estimation > 4500 g (clinical or ultrasonic) Subject declines participation Gestational age less than 37 completed weeks
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome: - Delivery by caesarean section Secondary outcomes: - Maternal: Instrumental delivery, duration of the active phase of labour, total duration of labour (from commencement of induction or time of onset of regular contractions if spontaneous onset), tachysystole, hyperstimulation, use of epidural analgesia, dose and duration of oxytocin infusion, episiotomy, rupture of the anal sphincter, uterine rupture, volume of blood loss at delivery and postpartum, need for evacuation of retained products of conception, use of antibiotics during labour, postpartum infection (defined as two measured maternal temperatures of 38ºC at least four hours apart), retention of urine requiring catheterisation) - Neonatal: Birth weight, Cardiotocogram (CTG) classification 12, fetal scalp pH values, Apgar score at 1 and 5 minutes, umbilical cord arterial and venous pH and blood gas values, use of antibiotics, hyperbilirubinaemia, neonatal admission, need for resuscitation (bag and mask or intubation, time to onset of spontaneous ventilation), or death. - Breastfeeding (time to established feeding and duration of exclusive or any breastfeeding) - Birth experience and satisfaction (Questionnaire made of components of existing validated Danish questionnaires) - Urinary incontinence after 6 months (Questionnaire: The International Consultation of Incontinence Questionnaire Short Form (ICIQ-SF)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |