Clinical Trial to evaluate the efficacy and safety of two drugs for pain relieve for pregnant women whose fetus is breech, to attempt to turn the baby
- Conditions
- 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 breech presentation in women with singleton pregnancy at term. Another objective is to compare their safety, tolerability and acceptability.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2011-003952-37-ES
- Lead Sponsor
- IS FERNÁNDEZ- LLEBREZ DEL REY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method