Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.J.H. Bakker

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Obstetrics and Gynaecology
H3-107
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
j.j.bakker@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Dauwtrappen of Nachtbraken

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Oxytocin

Primary outcome measures

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 trial start date

01/11/2003

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400

Participant 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

Recruitment start date

01/11/2003

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes