To investigate whether discontinuation of Syntocinon® infusion after the onset of active labour decreases caesarean section rates compared to usual care; continuation of oxytocin until the baby and placenta is born.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delivery by caesarean section
Secondary outcome
- Birth experience and satisfaction 4 weeks postpartum (Childbirth Experience
Questionnaire, CEQ1, Dencker 2010)
- Maternal: Instrumental vaginal delivery, duration of the active phase of
labour (from time of randomisation to delivery), total duration of labour (from
initiation time of oxytocin stimulation until delivery), duration of admission
on the delivery ward, 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, re-admission, retention of urine requiring catheterisation.
- Neonatal: Birth weight, CardioTocoGram (CTG) classification13, 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
breastfeeding)
Background summary
In The Netherlands 22% of all deliveries in 2013 were induced with synthetic
oxytocin (Syntocinon®). Although Syntocinon® is used in a high proportion of
labours, many professionals are unaware that oxytocin belongs to the top 10 of
most dangerous medications used in a hospital ( ISMP List of High Alert
Medications) and underestimate the adverse effects. The most frequent
complication is tachysystole, which increases the risk of fetal distress and
birth asphyxia, requiring delivery by caesarean section or forceps/ventouse.
Our hypothesis is that when the Syntocinon® infusion is stopped after the onset
of active labour the caesarean section rates will decrease compared to usual
care. Furthermore we expect better neonatal outcomes, less need for painrelief
and more satisfaction of the mother.
Study objective
To investigate whether discontinuation of Syntocinon® infusion after the onset
of active labour decreases caesarean section rates compared to usual care;
continuation of oxytocin until the baby and placenta is born.
Study design
International multicentre, double-blind randomised controlled trial
Intervention
Discontinuation of the Syntocinon® infusion once active labour has been
established.
Study burden and risks
It is possible that the delivery will take some more time for the women in the
intervention group. We expect benefit for the intervention group as
discontinuation of the Syntocinon® infusion will reduce the risk of
hyperstimulation and the consequences involved.
Østervangsvej 54
Randers NØ 8930
DK
Østervangsvej 54
Randers NØ 8930
DK
Listed location countries
Age
Inclusion criteria
Women with a singleton pregnancy with a gestational age of more than 37 weeks, a fetus in the
cephalic position, induced with intravenous oxytocin in the active phase of labour are eligible for the trial
Exclusion criteria
1. <18 years
2. Unable to read and understand the patient information or/and unable to give informed consent.
3. Non-cephalic presentation
4. Multiple gestation
5. Abnormal fetal heart rate pattern (cardiotocogram, CTG) before Syntocinon® initiation
6. Fetal weight estimation > 4500 g (clinical or ultrasonic)
7. Gestational age less than 37 completed weeks
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002942-30-NL |
| ClinicalTrials.gov | NCT02553226 |
| CCMO | NL57146.018.16 |