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
NTR285
Study information
Scientific title
To evaluate the effectiveness of the use of an IntraUterine Pressure Catheter (IUPC) in comparison to external monitoring of uterine activity during (I) augmentation after arrest of labor, or (II) induction of labour with intravenous oxytocin. Does the potentially more accurate monitoring of uterine activity with IUPC lead to a better outcome of labour and delivery in a study that randomises the use of an IUPC?
Acronym
The IUPC study
Study hypothesis
Our hypothesis is that use of an intrauterine pressure catheter (IUPC), during augmentation or induction of labour with intravenous oxytocin, will reduce the number of instrumental deliveries from 25% to 16%.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, single-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy, labour
Intervention
Intrauterine pressure monitoring with a catheter during labour versus external uterine activity monitoring (control group).
Intervention type
Drug
Phase
Not Specified
Drug names
Oxytocin
Primary outcome measure
The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
Secondary outcome measures
1. The occurrence of neonatal admittance to Neonatal Intensive Care Unit (NICU)
2. Need for antibiotics by mother or child
3. Total amount of oxytocin used
4. Complications
5. Time to delivery and costs
Overall trial start date
01/07/2004
Overall trial end date
01/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1350
Participant exclusion criteria
1. Women with a history of caesarean section
2. Gestational age less than 36 weeks
3. Intrauterine foetal death
4. Breech presentation
5. Multiple pregnancy
6. Maternal age greater than 18 years
7. Human immunodeficiency virus (HIV) or hepatitis B infection
8. Intrauterine infection
9. Contraindication for amniotomy
10. Participation in another randomised controlled trial
Recruitment start date
01/07/2004
Recruitment end date
01/07/2007
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
Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20107216
Publication citations
-
Results
Bakker JJ, Verhoeven CJ, Janssen PF, van Lith JM, van Oudgaarden ED, Bloemenkamp KW, Papatsonis DN, Mol BW, van der Post JA, Outcomes after internal versus external tocodynamometry for monitoring labor., N. Engl. J. Med., 2010, 362, 4, 306-313, doi: 10.1056/NEJMoa0902748.