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.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Caesarean section rate
Secondary outcome
Safety and Cost of both methods
Background 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.
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 prostaglandins.
Study design
Multicentre Randomized Controlled Clinical Trial
Intervention
Induction of labour with a transcervical Foley catheter as opposed to
intravaginal prostaglandins
Study burden and risks
Because we will compare two standard procedures, there will be no extra risk or
burden for participants of the study.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
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
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 | EUCTR2008-006246-26-NL |
CCMO | NL25271.018.08 |