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…
ID
Bron
Verkorte titel
Aandoening
stuitligging, uitwendige versie, uterus relaxatie, atosiban, oxytocine antagonist, fenoterol, betamimetica.
UK: breech presentation, external cephalic version, uterine relaxation, atosiban, oxytocine antagonist, fenoterol, betamimetics.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Succesfull version; number of cephalic presentations half an hour after the procedure;<br>
2. Fetal presentation at delivery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Comparison of a bolus atosiban 6,75 mg iv compared to a bolus 40 micrograms iv 15 minutes before ECV.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Pregnant women (from 18 years of age) with a live singleton fetus in breech presentation;
2. 32 weeks of gestation and onwards.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Contraindications to labour or vaginal birth;
2. Any contraindication to ECV;
3. Contra-indications for fenoterol or atosiban.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1767 |
| NTR-old | NTR1877 |
| Ander register | METC AMC : 26246 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |