E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Syntocinon is used for labour induction or labour augmentation 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. |
|
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. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
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 |
The proposed study will investigate the effect of Syntocinon® to induce
or augment 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 |
|
E.2.2 | Secondary objectives of the trial |
|
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) or for augmentation
of slow labour in the latent phase (regular contractions for at least four
hours and a cervical dilatation of ≤ 4cm). |
|
E.4 | Principal exclusion criteria |
<18 years and >45 years
Unable to read and understand the Danish language or to give informed consent
Cervical dilatation > 4 cm
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 |
|
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) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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
|
|
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 | 0 |
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 | 0 |