|- candidate number||5234|
|- NTR Number||NTR1646|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2009|
|- Secondary IDs||25271.018.08 NL|
|- Public Title||Comparison of Prostaglandin and Balloon catheter for induction of labour at term.|
|- Scientific Title||Evaluation of chemical (Prostaglandins) versus mechanical (transcervical balloon) methods for induction of labour at term.|
|- hypothesis||Induction of labour with a transcervical Foley catheter reduces the caesarean section rate as compared to induction of labour with prostaglandins.|
|- Healt Condition(s) or Problem(s) studied||Labour|
|- Inclusion criteria||1. Term pregnancy (>=37 weeks of pregnancy);|
2. Scheduled for induction of labour;
3. Vital singleton pregnancy;
4. Intact membranes;
5. Unfavourable cervix (Bishop score < 6);
6. Cephalic presentation.
|- Exclusion criteria||1. Previous caesarean section;|
2. Placenta praevia;
3. Hypersensitivity for one of the products used for induction;
4. Maternal age <18 years;
5. Severe/lethal congenital anomaly.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-feb-2009|
|- planned closingdate||31-dec-2010|
|- Target number of participants||812|
|- Interventions||Induction of labour with a transcervical Foley catheter compared to intravaginal prostaglandins.|
|- Primary outcome||Caesarean section rate.|
|- Secondary outcome||Maternal and neonatal morbidity (e.g. infection rate), to study the cost of both methods.|
|- Timepoints||Start inclusion: Februari 2009|
End inclusion: December 2010
Report: June 2011.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||drs. M. Jozwiak|
|- CONTACT for SCIENTIFIC QUERIES||Prof. B.W.J. Mol|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief summary||Induction of labour is an intervention designed to artificially initiate uterine contractions leading to progressive dilatation and effacement of the cervix and birth of the baby. Induction of labour is a common procedure: twenty-two percent of all deliveries were induced in the Netherlands in 2007. Compared to the spontaneous onset of labour, induction of labour is associated with prolonged labour, more instrumental deliveries and a higher rate of caesarean sections, especially when the cervix is unfavourable.
A recent Dutch survey showed a wide variety of methods being in use for induction of labour, intravaginal prostaglandin gel being used most frequently. A less frequently utilized method of ripening the uterine cervix is the transcervical Foley catheter. This inexpensive method is reported to have similar success-rates to induction of labour with intravaginal prostaglandins, and is associated with fewer abnormalities of contraction pattern and a lower caesarean section rate. However there are concerns that this method increases maternal and neonatal infectious morbidity.
To assess in term pregnant women with an unfavourable cervix (Bishop score < 6, Appendix1) the effectiveness of induction of labour with a transcervical Foley catheter as compared to induction with prostaglandins.
Multicentre Randomized Controlled Clinical Trial
Term pregnant women with an indication for induction of labour
Intervention (if applicable):
Induction of labour with a transcervical Foley catheter as opposed to intravaginal prostaglandins.
Main study parameters/endpoints:
Caesarean section rate
Maternal/Neonatal (infectious) morbidity
Analysis and sample size:
Analysis will be by intention to treat. We need two groups of 406 women (812 women) to demonstrate a reduction in caesarean section rate from 25% to 17%. As a variety of prostaglandin preparations is being used in the prostaglandin (control) group and Prostin® gel is the most commonly utilized, the aim is to include 812 patients for the Prostin® - Foley comparison. A total of approximately 1200 inclusions will be needed to achieve this.
|- Main changes (audit trail)||26-jul-2018 -IK:|
Post hoc, we planned a follow up , as the question has risen if the mechanical aspect of induction of labour with a Foley catheter can cause damage to the cervix and as a result, increase the risk of premature labour in a subsequent pregnancy. To answer this question we want to compare the rate of spontaneous premature birth between the groups randomised for a Foley catheter or Prostaglandin. We will screen the records of women participated in the PROBAAT-studies on an ongoing, subsequent pregnancy after the index delivery. If yes, we will collect the following data:
- Gestational age at delivery of the subsequent pregnancy (weeks +days)
- Onset of delivery (spontaneous, induction, planned caesarean section)
- Mode of delivery
- Birth weight
|- RECORD||30-jan-2009 - 26-jul-2018|