A randomized, multicentre, open label trial comparing the start of the induction of labor with intravenous oxytocin according to the circadian rhythm with standard care.
Completed
- Conditions
- Induction of labor with intravenous oxytocin.
- Registration Number
- NL-OMON22012
- Lead Sponsor
- AMC:J.J.H. Bakker, Dr.J.A.M. van der Post, Dr.R. de Vos.OLVG: Dr.J.M.M.van LithSLVZ:Drs.A.J.van Veelen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
Women are eligible to participate when the clinician judges that it is indicated to induce labor and the cervix is favourable for induction with a drip of oxytocin.
Exclusion Criteria
Excluded are women with:
1. Intrauterine fetal death;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The definition of the primary outcome is the duration of labor in minutes. <br />For the on protocol analysis in the final analysis of the trial, the duration of labor 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 /><br>For intention to treat analysis, the duration of labor is defined as the time of occupation of the labor room.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are the number of interventions like ventouse, forcipal extraction and caesarean section, number of children with an Apgar score below 7 after 5 minutes, number of intrapartum infections, necessity for pain relief and use of morphine, pethidine or epidural anaesthesia, and the patient satisfaction with quality of care.