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 misoprostol.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be a composite of complications of uterine
hyperstimulation, i.e. asphyxia and fluxus post partum. We will also compare
the instrumental delivery rate.
Secondary outcome
Mode of delivery (Caesarean section, vaginal instrumental delivery) and the
reason for instrumental delivery, i.e. suspected fetal distress and arrest of
labour.
Costs
Induction to delivery time
Maternal morbidity
Hyperstimulation (defined as more than five contractions in ten minutes over a
minimal period of two times ten minutes with and without FHR changes)
Hypertone uterus (defined as a contraction lasting more than three minutes)
Uterine rupture
Maternal infection
- Fever (defined as a rectal temperature >= 38°C) during labour or within one
week post partum
- Foetal tachycardia
- Start of intravenous broad-spectrum antibiotics
- Endomyometritis within one week post partum
Neonatal morbidity
Meconium -stained liquor
Epidural analgesia
Apgar scores <= 7 at 1 and 5 minutes
Umbilical cord pH < 7.10
Womans satisfaction (deze misschien eruit laten voor nu?)
Oxytocine use
Admissions to the neonatal ward
Background summary
Rationale: 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.
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. We recently showed that the use of a Foley
catheter resulted in an equal vaginal delivery rate as Prostaglandine E2 for a
lower rate of hyperstimulation, resulting in less asphyxia and less hemorrhage.
Another prostaglandine that is frequently used for induction of labour is
misoprostol. As direct comparisons between misoprostol and Foley catheter are
lacking, we propose a randomized comparison on the subject.
Study objective
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 misoprostol.
Study design
Multicentre Randomized Controlled Clinical Trial
Intervention
Induction of labour with a transcervical Foley catheter as opposed to oral
misoprostol
Study burden and risks
In this study two well established methods of induction of labour will be
compared, that both are mentioned in the Guidelines of the Dutch Society for
Obstetrics and Gynaecology. No additional physical examination is needed for
this study, nor will extra blood be taken from the subjects. A possible
additional burden might be the use of a vaginal speculum for placement of the
transcervical Foley catheter. Patient satisfaction will also be one of the
study outcomes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Term pregnancy (>=37 weeks of pregnancy)
Scheduled for induction of labour
Vital singleton pregnancy
Intact membranes
Unfavourable cervix (Bishop score < 6)
Cephalic presentation
Exclusion criteria
Previous caesarean section
Placenta praevia
Hypersensitivity for one of the products used for induction
Maternal age <18 years
Lethal congenital anomaie
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-000026-30-NL |
| CCMO | NL35278.018.11 |