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
| ISRCTN | ISRCTN52897947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52897947 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.J.H. Bakker
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Obstetrics and Gynaecology, H3-107
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
| j.j.bakker@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | 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 |
| Study acronym | Dauwtrappen of Nachtbraken |
| Study objectives | Our hypothesis is that induction of labour with intravenous oxytocin starting in the evening, following the circadian rhythm, shortens the duration of labour compared to a start in the early morning. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Induction of labour with intravenous oxytocin |
| Intervention | 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). Both groups are treated by the exactly the same protocol, except for the timing of the start of induction. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oxytocin |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/11/2003 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 400 |
| Total final enrolment | 371 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2009 | 15/07/2021 | Yes | No |
Editorial Notes
15/07/2021: Publication reference and total final enrolment added.
