Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT01735669
Eligibility Criteria:
Inclusion Criteria:
1. pregnancy at term (≥ 37 weeks)
2. singleton foetus in non-cephalic presentation
3. correct foetal cardiotocographic record
4. obstetrical ultrasound examination without findings of serious foetal malformations
5. indication for the performance of ECV
6. acceptance of ECV
7. age ≥ 18 years
8. signature of informed consent
Exclusion Criteria:
1. previous version in the same pregnancy (previous ECV in a different pregnancy allowed)
2. contraindications to ECV: 1-placenta praevia, 2- placental abruption, 3-oligohydramnios (SPD \<2), 4-foetal compromise 5-foetal death, 6-severe malformations, 7-multiple pregnancy, 8- Rh sensitization, 9- uterine abnormalities, 10- clotting disorders;
3. 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.
4. contraindications for remifentanil: hypersensitivity to remifentanil, fentanyl or fentanyl analogs or to any component of its formulation (according to technical requirements by manufacturer).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01735669
Study Brief:
Protocol Section:
NCT01735669