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Intrauterine pressure monitoring for augmentation or induction of labour with intravenous oxytocin: benefits and costs
ISRCTN ISRCTN13667534
DOI 10.1186/ISRCTN13667534
ClinicalTrials.gov identifier
EudraCT number
Public title Intrauterine pressure monitoring for augmentation or induction of labour with intravenous oxytocin: benefits and costs
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
Serial number at source NTR285
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%.
Lay summary
Ethics approval Received from the local medical ethics committee
Study design Multicentre, randomised, single-blind, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Pregnancy, labour
Participants - inclusion criteria Women with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour.
Participants - 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
Anticipated start date 01/07/2004
Anticipated end date 01/07/2007
Status of trial Completed
Patient information material
Target number of participants 1350
Interventions Intrauterine pressure monitoring with a catheter during labour versus external uterine activity monitoring (control group).
Primary outcome measure(s) The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
Secondary outcome measure(s) 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
Sources of funding Academic Medical Centre (AMC) (Netherlands)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20107216
Contact name Dr  J.J.H.  Bakker
  Address Academic Medical Centre (AMC)
Department of Obstetrics and Gynaecology, H3-107
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Email j.j.bakker@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address Department of Obstetrics and Gynaecology
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 20/12/2005
Last edited 29/01/2010
Date ISRCTN assigned 20/12/2005
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