|- candidate number||12874|
|- NTR Number||NTR3466|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jun-2012|
|- Secondary IDs||35278 ABR|
|- Public Title||Induction of labour with oral misoprostol or Foley catheter at term.|
|- Scientific Title||Induction of labour with oral misoprostol or Foley catheter at term.|
|- hypothesis||To investigate the effectivenes, safety and women's preference of induction of labour with a Foley catheter compared to oral misoprostol within term women with an unfavourable cervix.|
|- Healt Condition(s) or Problem(s) studied||Induction of labour, Misoprostol , Foley catheter|
|- Inclusion criteria||1. Term women (37 weeks and more);|
2. Scheduled for induction;
3. Vital singlet in cephalic presentation;
4. Intact membranes;
5. Unfavourable cervix (Bishop score < 6).
|- Exclusion criteria||1. History of sectio caesarea;|
2. Placenta praevia;
3. Maternal age < 18 years;
4. Lethal congenital malformations.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-jun-2014|
|- Target number of participants||1860|
|- Interventions||Induction of labor with oral misoprostol 50 ug tablets.|
|- Primary outcome||Percentage of post partum hemorrhage (defined as more than 1000 cc blood loss) and asphyxia (defined as an apgar score <7 at 5 minutes and/or umbilical cord Ph < 7.05).|
|- Secondary outcome||1. Mode of delivery (Caesarean section, vaginal instrumental delivery) and the reason for instrumental delivery, i.e. suspected fetal distress and arrest of labor;|
2. Induction to delivery time;
3. Use of analgesics;
4. Oxytocin use;
5. Maternal morbidity;
6. Maternal post partum blood transfusion;
7. Hyperstimulation (defined as more than five contractions in ten minutes over a minimal period of two times ten minutes with FHR changes)
Uterine hypertonus (defined as a contraction lasting more than three minutes with FHR changes);
8. Uterine rupture (separation of the uterine wall);
9. Maternal infection;
10. Fever (defined as a temperature ≥ 37.8 degrees C) during labor or fetal tachycardia and start of antibiotics;
11. Fever (defend as a temperature ≥ 37.8 degrees C) within one week post partum and start of antibiotics;
12. Fetal tachycardia (a sustained fetal heart rate above 160 beats per minute);
13. Start of intravenous broad-spectrum antibiotics
Endo(myo)etritis or urinary tract infection within one week post partum (proven positive vaginal discharge/urine culture);
14. Neonatal morbidity;
15. Meconium stained liquor;
16. Apgar scores < 7 at 1 and 5 minutes;
17. Admissions to the neonatal ward/NICU;
18. Women's preference;
|- Timepoints||1-6-2012: Start inclusions;|
1-6-2014: End of inclusions;
1-1-2015: Analysis of the data and publication.
|- Trial web site||www.studies-obsgyn.nl/probaat2|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Mieke L.G. Eikelder, ten|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Mieke L.G. Eikelder, ten|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Induction of labor is an intervention designed to artificially initiate the process of effacement of the cervix, dilatation, uterine contractions (often after augmentation with oxytocin) and eventually delivery of the baby. Induction of labor is a common procedure: twenty-two percent of all deliveries were induced in the Netherlands in 2007. A recent Dutch survey showed a wide variety of methods being used for induction of labor, intravaginal prostaglandin gel being used most frequently. A less frequently utilized method of ripening the uterine cervix is the transcervical Foley catheter. We recently showed that the use of a Foley catheter, in term women with an unfavorable cervix, resulted in equal vaginal delivery rates when compared to vaginal Prostaglandin E2 gel. And a meta-analysis showed lower rates of hyperstimulation, resulting in less asphyxia and postpartum haemorrhage.
Another prostaglandin that is frequently used for induction of labor is misoprostol (PGE1), which is recommended by the international federation of gynaecology and obstetrics (FIGO) for induction of labor. Misoprostol is used both vaginal and oral. The oral way seems to have lower rates of asphyxia and hyperstimulation. As direct comparisons between oral misoprostol and Foley catheter are lacking, we propose a randomized controlled trial comparing Foley catheter to oral misoprostol.
To assess in term pregnant women with an unfavorable cervix (Bishop score < 6, Appendix1) the effectiveness of induction of labor with a transcervical Foley catheter as compared to induction with oral misoprostol.
Multicentre Randomized Controlled Clinical Trial.
Term pregnant women with an unfavorable cervix and an indication for induction of labor.
Induction of labor with a transcervical Foley catheter as compared to oral misoprostol.
Main study parameters/endpoints:
The primary outcome will be a composite outcome of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are costs, women's preference, mode of delivery and maternal and neonatal morbidity.
Analysis and sample size:
This trial will be performed as a non-inferiority trial. Therefore, analysis will be done by per protocol analysis and by intention to treat, Our primary outcome will be a composite of asphyxia (pH¡Ü7.10 and/or 5 minute Apgar<7) and haemorrhage ≥1000 cc post partum. With a power of 80% (1-¦Â) a one-sided 0.05 risk of type I error (¦Á) we calculated that we would require 1860 participants (930 per group) to demonstrate non-inferiority, i.e. that the absolute difference in the composite outcome was less than 5% more in the misoprostol group than in the Foley catheter group.
|- 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||7-jun-2012 - 26-jul-2018|