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