Open randomized controlled trial to evaluate the efficacy and safety of remifentanil versus nitrous oxide in the external cephalic version at term in singleton pregnancy in breech presentation, COD: REMIVER - REMIVER

IS FERNÁNDEZ- LLEBREZ DEL REY0 个研究点开始时间: 2012年2月28日最近更新: 2012年5月23日

适应症

试验速览

暂无简介。

•a) pregnancy at term (? 37 weeks)
•b) singleton fetus in breech presentation
•c) correct fetal cardiotocographic record
•d) obstetrical ultrasound examination without findings of serious fetal malformations
•e) indication for the performance of ECV
•f) acceptance of ECV g) age ? 18 years h) signature of informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a) Previous version in the same pregnancy
•b) Contraindications to ECV: 1-Placenta praevia, 2- placental abruption, 3-oligohydramnios (SPD <2), 4-fetal compromise 5-fetal death, 6-severe malformations, 7-multiple pregnancy, 8- Rh sensibilization, 9- uterine abnormalities, 10- clotting disorders;
•c) 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-embolism; 7-immersion accident, 8-bloating abdominal 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.
•d) Contraindications for remifentanil: hypersensitivity to remifentanil, fentanyl or fentanyl analogs, or any component of its formulation.

发起方

IS FERNÁNDEZ- LLEBREZ DEL REY