|- candidate number||1479|
|- NTR Number||NTR285|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Intra uterine 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 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?|
|- ACRONYM||The IUPC study|
|- hypothesis||Our 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) studied||Pregnancy, Labour|
|- Inclusion criteria||Women with the indication to induce labour or to stimulate the contractions with intravenous oxytocin in case of arrest of labour.|
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2004|
|- planned closingdate||1-jul-2007|
|- Target number of participants||1350|
|- Interventions||Intra uterien pressure monitoring with a catheter during labour. |
|- Primary outcome||The number of instrumental deliveries, i.e. caesarean sections and/or assisted vaginal delivery.|
|- Secondary outcome||1. The occurrence of neonatal admittance to NICU; |
2. Need for antibiotics by mother or child;
3. Total amount of oxytocin used;
5. Time to delivery and costs.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. J.J.H. Bakker|
|- CONTACT for SCIENTIFIC QUERIES||Dr. MD. PhD. J.A.M. Post, van der|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Obstetrics and Gynaecology |
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||In 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)|
|- RECORD||11-sep-2005 - 9-dec-2009|