Skip to content

A randomised, multicentre, open label trial comparing the start of the induction of labour with intravenous oxytocin according to the circadian rhythm with standard care

A randomised, multicentre, open label trial comparing the start of the induction of labour with intravenous oxytocin according to the circadian rhythm with standard care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52897947
Enrollment
400
Registered
2005-12-20
Start date
2003-11-01
Completion date
Unknown
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of labour with intravenous oxytocin Pregnancy and Childbirth Labour induction

Interventions

The women who start with induction of labour in the evening (21:00 hours) are defined as the intervention group. The control group are those women who start in the early morning (07:00 hours).

Sponsors

Academic Medical Centre (AMC) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women are eligible to participate when the clinician judges that it is favourable to induce labour and the cervix is favourable for induction with a drip of oxytocin.

Exclusion criteria

Exclusion criteria: 1. Intrauterine foetal death 2. Maternal age below 18 years 3. Insufficient understanding of the meaning of the trial 4. Language problems 5. Contraindication for amniotomy 6. Secondary caesarean section in the medical history 7. Gestational age shorter than 36 weeks 8. Necessity for timed or immediate intervention because of suspected foetal distress

Design outcomes

Primary

MeasureTime frame
The definition of the primary outcome is the duration of labour in minutes: 1. For the on protocol analysis in the final analysis of the trial, the duration of labour is defined as the time measured from start of the drip until time of birth of the baby, in case of twins the time of the first baby 2. For intention to treat analysis, the duration of labour is defined as the time of occupation of the labor room

Secondary

MeasureTime frame
1. Number of interventions like ventouse, forcipal extraction and caesarean section 2. Number of children with an Apgar score below 7 after 5 minutes 3. Number of intrapartum infections 4. Necessity for pain relief and use of morphine, pethidine or epidural anaesthesia 5. Patient satisfaction with quality of care

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026