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ECV with uterine relaxation

 

Go to the ECV website

 

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 uterine relaxant in external cephalic version.


Study design
The proposed design is an open label randomised controlled trial comparing atosiban with fenoterol as a uterine relaxant 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.


Studypopulation


Inclusioncriteria

1.      Live singleton fetus

2.      Breech presentation

3.      Gestational age of 32 weeks and onwards

4.      Maternal age of 18 years or more

 

Maternalexclusion criteria;

1. Any contra-indication to labour or vaginal birth (eg placenta praevia)

2. Any contra-indication to ECV:

  - A scarred uterus other than transverse in the lower segment

  - Known uterine anomalies

  - Placental abruption in the obstetric history

  - Preeclampsia or eclampsia

  - Third trimester blood loss (7 days prior to ECV)

  - Ruptured membranes
3. Any contra-indication to atosiban or fenoterol:
  - Cardiovascular disease
  - Hyperthyreoidism
  - Elevated liver enzyme or renal dysfunction
  - Infection of the amniotic cavity
  - Simultaneous use of prostaglandin inhibitors (aspirine, diclofenac, ibuprofen), 
    beta-blockers (labetalol (trandate), xanthine derivatives (theofylline), 
    tricyclic antidepressants (amitriptyline, sarotex, tryptizol), calcium, vitamin D. 
 
Fetalexclusion criteria; 

1. Suspected severe intrauterine growth restriction(<P5 for gestational age assessed by ultrasonography) or severe oligohydramnios (deepest pool < 2cm)

2. Fetal anomalies or an extended fetal head (very rare)

3. Non reassuring signs of fetal well-being;non-reassuring fetal heart rate monitoring

 

Intervention
One group receives a bolus of 6.75 mg (7.5 mg/ml) atosiban i.v. and the other group receives a bolus of 40 micrograms (0,5 mg/10 ml) fenoterol i.v., starting 15 minutes before version.

 

Outcomemeasures
The primary outcome is a fetus being in cephalic position immediately after the procedure. Secondary outcome measures include cephalic presentation at delivery, mode of delivery, side effects and adverse events.

 

Study parameters/endpoints

 

Main study parameter/endpoint

1.       Successful version; number of cephalic presentations half an hour after the procedure

2.       Fetal presentation at delivery

 

Other outcomes

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, occult or overt umbilical cord prolapse, (P)PROM, placental abruption, emergency delivery, fetal death.

3.  Adverse events due to atosiban or fenoterol; chest pain, nausea, vomiting, headaches, flushing, dizziness, hypotension (associated with fainting or CTG abnormalities), tachycardia resulting in palpitationsfor more than 5 minutes, local reaction of the skin after injection of the medication, anaphylactic shock, cessation of treatment due to side effects.


Power/data analysis
The analyses will be intention to treat. A difference in successful ECV of 10%, with beta of 0,2 and alpha of 0,05 can be detected if 806 patients can be analysed (403 in each arm). We feel that a 10% difference between these drugs is necessary to prefer one above the other.

 

Time schedule
Inclusion study will take place from August 2009 to August 2013.

 

Projectleaders
Prof. dr. B.W. Mol, gynaecologist, AMC Amsterdam

Prof.dr. J.A.M. van der Post, gynaecologist, AMC Amsterdam


Contact

Prof. dr. B.W. Mol, gynaecologist, AMC Amsterdam