Approximately a third of women become delayed in their first labours and are given intravenous oxytocin in an attempt to increase their uterine contractions and thereby increase spontaneous vaginal birth.
Conditions
Interventions
Trade Name: Syntocinon injection ampoules 5iu/ml
Product Name: Syntocinon injection ampoules 5 IU/ml
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Oxytocin PhEur 5 units in 1 ml
Conce
Sponsors
University of Birmingham
Birmingham Women's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Eligible women included • Consenting nulliparous women with a singleton pregnancy at term (37-42 weeks) gestation. • Confirmed delay in labour as defined by NICE Intrapartum Care Guideline and with ruptured membranes. Labour is established when there are regular painful contractions and progressive cervical dilation from 4cm. Delay is suspected when cervical dilatation of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria include • Under 16 years old induction, • BMI > 40 • multiple pregnancy, • existing maternal or fetal disease or concern, • gestational diabetes • previous uterine surgery, • vaginal bleeding in this pregnancy of clinical significance or • contra-indication to oxytocin therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This pilot study based in 3 maternity units will recruit approximately 100 women. It is the pilot for a proposed multicentre trial which would compare standard (2mu/min increasing to 32mu/min)and high dose (4mu/min increasing to 64mu/min)oxytocin in approximately 4300 women from 24 centres. The main hypothesis of the trial is that the use of high dose oxytocin will achieve more effective uterine contractions resulting not only in shorter labours but in a higher chance of vaginal birth in women who are diagnosed as having delay in the first stage of labour. The regimen we will evaluate has a higher starting dose, earlier attainment of conventional maximum doses (at 2 hours rather than over 4 hours) and the use of higher maximum doses of oxytocin compared to the standard regimen used at present. This pilot based in 3 maternity units (representative of those participating in the main trial) will be crucial to inform the main trial and will develop and evaluate: • numbers of women elig;Secondary Objective: N/A;Primary end point(s): The size of the pilot study will not allow reliable assessment of the effect of the intervention on clinical outcomes and so hypothesis testing is not proposed. The primary outcome for the main study is spontaneous vaginal birth. In the pilot study, analyses will principally take the form of simple descriptive statistics of process outcomes including eligibility and recruitment rates, and of SVB and secondary clinical outcomes, to aid designing of the main trial. Regression models appropriate to the forms of data will also be fitted, to allow adjustment for covariates. | — |
Countries
United Kingdom
Outcome results
None listed