For women with a singleton fetus in breech presentation at term, this study answers the question if atosiban is more effective compared to fenoterol as a tocolyticum in external cephalic version
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 is a fetus being in cephalic position immediately after the
procedure.
Secondary outcome
Secondary outcome measures include cephalic presentation at delivery, mode of
delivery, side effects and adverse events.
Background summary
External cephalic version (ECV) of the fetus in breech position is a safe and
relatively simple obstetrical intervention that reduces the incidence of
caesarean section for breech position at term. Uterine relaxation can enhance
the success rate of ECV significantly. The most studied and widespread used
uterine relaxants are the beta-agonists, but these are not widely accepted in
daily obstetrical practice because of cardiovascular side effects.
Nifedipine ( a calcium channel blocker) and atosiban (an oxytocin-receptor
antagonist) have been proven successful as tocolytics in preventing preterm
labour and have replaced beta-agonists. Studies evaluating nifedipine or
atosiban reported significantly less drop outs because of adverse drug
reactions in comparison with beta-agonists. However, a RCT comparing nifedipine
versus placebo for ECV could not show a significant difference on success rate.
This trial will compare the effectiveness of atosiban with fenoterol
(beta-agonist) during ECV in women with a singleton fetus in breech
presentation at term.
Study objective
For women with a singleton fetus in breech presentation at term, this study
answers the question if atosiban is more effective compared to fenoterol as a
tocolyticum in external cephalic version
Study design
The proposed design is an open label randomised controlled trial comparing
atosiban with fenoterol as a tocolyticum during ECV. Patients assigned for
randomisation will be stratified by centre and parity. This trial will be
carried out by physicians and midwives who have experience in the ECV
manoeuvre.
Intervention
One group receives 6.75 mg in 0.9 ml (7.5 mg/ml) atosiban i.v. and the other
group receives a 40 microgram in 0.8 ml (0.5mg / 10 ml) fenoterol i.v. as a
bolus.
Study burden and risks
There ar no other burden or risks for patients included in this study, compared
to daily clinical practice for women with a singleton fetus in breech
presentation at term.
Meibergdreef 9, kamer H4-213
1105 AZ Amsterdam
NL
Meibergdreef 9, kamer H4-213
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Breech presentation
Exclusion criteria
Any contraindication to labour or vaginal birth (eg placenta praevia)
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 | EUCTR2008-007344-34-NL |
| CCMO | NL26246.018.08 |