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. MedDRA version: 20.0 Level: LLT Classification code 10062462 Term: Labor stimulation System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10023540 Term: Labor induced
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Oxytocin
Pharmaceutical Form: Injection
INN or Proposed INN: Oxytocin
CAS Number: 50-56-6
Other descriptive name: Syntocinon
Concentration unit: IU/ml internationa
Sponsors
Regional Hospital of Randers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin and a cervical dilatation of = 4cm). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 4500 g (clinical or ultrasonic) Subject declines participation Gestational age less than 37 completed weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: Not applicable;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) ;Timepoint(s) of evaluation of this end point: Is listed in the above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Is listed in E.5.1;Timepoint(s) of evaluation of this end point: Is listed in E.5.1 | — |
Countries
Denmark, Netherlands
Contacts
Public ContactRegional Hospital of Randers
Department of Obstetrics and Gynecology, Regional Hospital of Randers
Outcome results
None listed