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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20107216

Publication citations

  1. 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.

Editorial Notes