No registrations found.
ID
Source
Brief title
Health condition
stuitligging, uitwendige versie, uterus relaxatie, atosiban, oxytocine antagonist, fenoterol, betamimetica.
UK: breech presentation, external cephalic version, uterine relaxation, atosiban, oxytocine antagonist, fenoterol, betamimetics.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Succesfull version; number of cephalic presentations half an hour after the procedure;
2. Fetal presentation at delivery.
Secondary outcome
1. Mode of delivery; vaginal delivery (spontaneous or instrumental), CS (prelabor or during labor);
2. Complications of ECV; persistent non-reassuring fetal CTG after ECV, umbilical cord prolapse, (P)PROM, placental abruption, emergency delivery, fetal death;
3. Adverse events due to atosiban or fenoterol; chest pain, nausea, vomitting, headaches, flushing, dizziness, hypotension (associated with fainting or CTG abnormalities), tachycardia resulting in palpitations, local reaction of the skin on injection of the medication, anaphylactic shock, cessation of treatment due to side effects.
Background summary
External cephalic version (ECV) is proven effective to reduce the number of caesarean sections in breech presentation at term. Untill now, betamimetics are the only effective uterine relaxants; they increase the succes rate of ECV by 40% and consequently lower the number of caeserean sections. Nevertheless, this medication has side effects which often leads to palpitations. Therefore, implementation of this treatment is limited. In this study, we compare fenoterol with atosiban to find out if atosiban is comparable to fenoterol in women with a breech presentation at term.
Study objective
External cepahlic version (ECV) of the fetus in breech position is a safe and relative simple obstetric intervention to reduce the incidence of caeserean section for breech position at term. Uterine relaxants can enhance the success rate of ECV with 40%. Betamimetica (fenoterol) is proven effective as uterine relaxant in ECV, but has several side effects due to which it is not used on daily basis. This trial will compare the effectiveness of atosiban with fenoterol during ECV in women with a singleton fetus in breech presentation at term.
Study design
N/A
Intervention
Comparison of a bolus atosiban 6,75 mg iv compared to a bolus 40 micrograms iv 15 minutes before ECV.
Dept Gynaecology & Obstetrics, H4-140.1
Meibergdreef 8
F. Vlemmix
Academic Medical Center (AMC)
Dept Gynaecology & Obstetrics, H4-140.1
Meibergdreef 8
Amsterdam 1105AZ
The Netherlands
+31-(0)20-5666199
F.Vlemmix@amc.uva.nl, f.vlemmix@gmail.com
Dept Gynaecology & Obstetrics, H4-140.1
Meibergdreef 8
F. Vlemmix
Academic Medical Center (AMC)
Dept Gynaecology & Obstetrics, H4-140.1
Meibergdreef 8
Amsterdam 1105AZ
The Netherlands
+31-(0)20-5666199
F.Vlemmix@amc.uva.nl, f.vlemmix@gmail.com
Inclusion criteria
1. Pregnant women (from 18 years of age) with a live singleton fetus in breech presentation;
2. 32 weeks of gestation and onwards.
Exclusion criteria
1. Contraindications to labour or vaginal birth;
2. Any contraindication to ECV;
3. Contra-indications for fenoterol or atosiban.
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 | NL1767 |
| NTR-old | NTR1877 |
| Other | METC AMC : 26246 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |