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.
Conditions
Interventions
Trade Name: Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital
Product Name: Remifentanilo
Product Code: Remifentanilo
Pharmaceutical Form: Powder for solutio
Sponsors
LUIS FERNÁNDEZ- LLEBREZ DEL REY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1 - To compare the analgesic effect of both treatments. 2 - To compare their safety. 3 - To compare the satisfaction of pregnant women with both pain treatments. 4 - To explore the factors that influence on the success of ECV in patients receiving remifentanil. 5 - To explore the logistical factors associated with the difficulty in the implementation and dissemination of this technique. 6 - To compare the cesarean rate with both treatments.;Main Objective: To compare the effect of remifentanil vs nitrous oxide on the success rate in external cephalic version at term in singleton pregnancies in breech presentation.;Primary end point(s): Outcome variables (efficacy): Primary endpoint: rate (proportion) of successful ECV maneuvers;Timepoint(s) of evaluation of this end point: The primary endpoint is assessed inmediately after the maneuver | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Outcome variables (efficacy): Secondary endpoints: 1- number of attempts made by the obstetrician 2- number of attempts perceived by pregnant women 3- pain experienced by the patient during the ECV (visual analogue scale), 4- satisfaction with the maneuver performed through a questionnaire with 2 questions with closed answers: 1 - How was the experience?, 2 - Would you accept the procedure to be repeated in another pregnancy?),5- data on foetal presentation at delivery, 6- rate (proportion) of Caesarean-sections.7- Morbidity and perinatal outcomes at birth (Apgar scores at 1 and 5 minutes after delivery, acid base balance). 8- Admission rate in the neonatal intensive care unit. 9- Delivery- related Morbidity during the stay in hospital (48 -72 hours after birth). Outcome variables (security): incidence and characterization (type, severity, resolution) of adverse events and adverse events attributable to the trial treatments.;Timepoint(s) of evaluation of this end point: Some outcomes (1-4) are assessed inmediately after the maneuver. The others (5-9) are assessed after the birth and during the stay in hospital (usually 48- 72 hours) | — |
Countries
Spain
Contacts
Public ContactUNIDAD DE INVESTIGACIÓN
HOSPITAL DE CRUCES
Outcome results
None listed