Open Randomized Controlled Trial to Evaluate the Efficacy and Safety of Remifentanil Versus Nitro… (NCT01735669) | Clinical Trial Compass
CompletedPhase 3
Open Randomized Controlled Trial to Evaluate the Efficacy and Safety of Remifentanil Versus Nitrous Oxide in External Cephalic Version at Term in Singleton Pregnancy in Breech Presentation
Spain120 participantsStarted 2012-07
Plain-language summary
Objectives: The objective is to demonstrate the superiority of remifentanil versus nitrous oxide as adjuvant analgesic treatment to increase the chances of success of external cephalic version in the management of non-cephalic presentation in women with singleton pregnancy at term. Another objective is to compare their safety, tolerability and acceptability.
Methodology: single-center clinical trial, randomized, open, parallel-group and sequential design, with active comparator. Pragmatic approach. Sequential design of O'Brien-Fleming with two interim analysis. Analysis by intention to treat. Comparison of the rate of successful version, referred to analgesic effect, safety, caesarean rates and acceptability rate of the procedure for pregnant women.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. pregnancy at term (≥ 37 weeks)
✓. singleton foetus in non-cephalic presentation
✓. correct foetal cardiotocographic record
✓. obstetrical ultrasound examination without findings of serious foetal malformations
✓. indication for the performance of ECV
✓. acceptance of ECV
✓. age ≥ 18 years
✓. signature of informed consent
Exclusion criteria
✕. previous version in the same pregnancy (previous ECV in a different pregnancy allowed)
. contraindications to Nitrous Oxide: 1-patients who require pure oxygen ventilation 2- intracranial hypertension 3- disorders of consciousness that impede the cooperation of the patient, 4-pneumothorax; 5-emphysematous bulla, 6-pulmonary embolism; 7-immersion accident, 8-bloating abdominal trauma 9- facial trauma that affects the area of application of the mask,10- patients who received the type gases SF6, C3F8, C2F6 (used in eye surgery), at least in the previous three months.
✕. contraindications for remifentanil: hypersensitivity to remifentanil, fentanyl or fentanyl analogs or to any component of its formulation (according to technical requirements by manufacturer).