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External Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.

External Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20784
Enrollment
806
Registered
2009-06-25
Start date
2009-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stuitligging, uitwendige versie, uterus relaxatie, atosiban, oxytocine antagonist, fenoterol, betamimetica. UK: breech presentation, external cephalic version, uterine relaxation, atosiban, oxytocine antagonist, fenoterol, betamimetics.

Interventions

Comparison of a bolus atosiban 6,75 mg iv compared to a bolus 40 micrograms iv 15 minutes before ECV.

Sponsors

Academic Medical Center (AMC)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Contraindications to labour or vaginal birth; 2. Any contraindication to ECV; 3. Contra-indications for fenoterol or atosiban.

Design outcomes

Primary

MeasureTime frame
1. Succesfull version; number of cephalic presentations half an hour after the procedure; 2. Fetal presentation at delivery.

Secondary

MeasureTime frame
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.

Contacts

Public ContactF. Vlemmix

Academic Medical Center (AMC) Dept Gynaecology & Obstetrics, H4-140.1 Meibergdreef 8

F.Vlemmix@amc.uva.nl, f.vlemmix@gmail.com+31-(0)20-5666199

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)