No registrations found.
ID
Source
Brief title
Health condition
Breech presentation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Succesfull version.
Secondary outcome
1. Cephalic presentation at birth;
2. Caesarean section rate;
3. Fetal complications;
4. Maternal complications.
Background summary
External cephalic version (ECV) without tocolysis after 36 weeks of gestation can reduce the breech presentation by 41%. ECV with tocolysis is more successful and has a success rate of 57%.
Currently used tocolytics have maternal cardiovascular side-effects in terms of flushing and palpitations and therefore seldom used in clinical practice. A new tocolytic nifedipine, a calcium antagonist exists wich has significant less side effects(5).
Therefore, the goal of this trial is to asses for women with a singleton at term fetus in breech presentation the success rate of external cephalic version (ECV) with a calcium antagonist nifedipine compared to version without medication?
Study objective
For women with a singleton at term fetus in breech presentation, what is the success rate of external cephalic version (ECV) with a calcium antagonist nifedipine compared to version without medication?
Study design
N/A
Intervention
Group 1:
external cephalic version with tocolysis (adalat 10 mg orally 30 and 15 minutes before procedure);
Group 2:
external cephalic version without tocolysis.
H4-205,
P.O. Box 22660
M. Kok
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664167
mkok@amc.uva.nl
H4-205,
P.O. Box 22660
M. Kok
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664167
mkok@amc.uva.nl
Inclusion criteria
Pregnant women (from 18 years of age) with a live singleton at term fetus in breech presentation.
Exclusion criteria
Contraindications to labour or vaginal birth, any contraindication to ECV, contra-indications for nifedipine.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL109 |
| NTR-old | NTR140 |
| Other | : N/A |
| ISRCTN | ISRCTN28715121 |