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
Not Applicable
Completed
- Conditions
- Induction of labour with intravenous oxytocinPregnancy and ChildbirthLabour induction
- Registration Number
- ISRCTN52897947
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
2009 Results article in https://pubmed.ncbi.nlm.nih.gov/19250367/ (added 15/07/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 371
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The definition of the primary outcome is the duration of labour in minutes:<br> 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<br> 2. For intention to treat analysis, the duration of labour is defined as the time of occupation of the labor room<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Number of interventions like ventouse, forcipal extraction and caesarean section<br> 2. Number of children with an Apgar score below 7 after 5 minutes<br> 3. Number of intrapartum infections<br> 4. Necessity for pain relief and use of morphine, pethidine or epidural anaesthesia<br> 5. Patient satisfaction with quality of care<br>