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Intra uterine pressure monitoring for augmentation or induction of labour with intravenous oxytocin: Benefits and costs.


- candidate number1479
- NTR NumberNTR285
- ISRCTNISRCTN13667534
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleIntra uterine pressure monitoring for augmentation or induction of labour with intravenous oxytocin: Benefits and costs.
- Scientific TitleTo evaluate the effectiveness of the use of an intra uterine 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 radomizes the use of an IUPC?
- ACRONYMThe IUPC study
- hypothesisOur hypothesis is that use of an IUPC, during augmentation or induction of labour with intravenous oxytocin, will reduce the number of instrumental deliveries from 25% to 16%.
- Healt Condition(s) or Problem(s) studiedPregnancy, Labour
- Inclusion criteriaWomen with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour.
- Exclusion criteria1. Women with a history of caesarean section;
2. Gestational age<36 weeks;
3. Intra uterine fetal death;
4. Breech presentation;
5. Multiple pregnancy;
6. Maternal age<18 years;
7. HIV- or hepatitis B-infection;
8. Inta uterien infection;
9. Contra indication for amniotomy;
10. Participation in another RCT.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2004
- planned closingdate1-jul-2007
- Target number of participants1350
- InterventionsIntra uterien pressure monitoring with a catheter during labour.
- Primary outcomeThe number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
- Secondary outcome1. The occurrence of neonatal admittance to NICU;
2. Need for antibiotics by mother or child;
3. Total amount of oxytocin used;
4. Complications;
5. Time to delivery and costs.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc. J.J.H. Bakker
- CONTACT for SCIENTIFIC QUERIESDr. MD. PhD. J.A.M. Post, van der
- Sponsor/Initiator Academic Medical Center (AMC), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIn The Netherlands, approximately 10.000 deliveries are induced with oxytocin and 15.000 deliveries are augmented each year (LVR 2, 2002).
Many clinicians monitor frequency and strength of contractions with an intrauterine pressure catheter (IUPC). It is questionable whether monitoring contractions with IUPC is beneficial in terms of maternal or fetal outcome and whether it is cost effective.
- The aim of the study is to evaluate the effectiveness of IUPC in comparison to external monitoring during induction of labour.
Women will be at random allocated to placement of an IUPC (intervention group) or external uterine activity monitoring (control group).
- The primary outcome measure will be the number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.
- Secondary outcome measures are the occurrence of neonatal admittance to ICU, need for antibiotics by mother or child, total amount of oxytocin used, complications, time to delivery and costs.
- The study will be designed as an equivalence study. Under the assumption of equal neonatal and maternal morbidity, it is hypothesised that IUPC will reduce the number of instrumental deliveries from 25% to 16%. Analysis will be by intention to treat.
- Main changes (audit trail)
- RECORD11-sep-2005 - 9-dec-2009


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