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 (REMIVER)
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Purpose
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 breech 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breech Presentation Inhalation of Nitrous Oxide Pregnancy Complications Complications; Cesarean Section Fetus or Neonate Affected by External Version Before Labor |
Drug: Remifentanil Drug: Nitrous Oxide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Degree of decrease in pain experienced by patients during the external cephalic version in singleton pregnancies in breech presentation at term according to the VAS [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]Degree of decrease in pain experienced by patients during the external cephalic version in singleton pregnancies in breech presentation at term according to the VAS
- Rate of adverse events and severity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Degree of satisfaction of pregnant women [ Time Frame: 60 min ] [ Designated as safety issue: No ]
- Rate of breech presentation in the delivery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Rate of caesarean section [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Remifentanil
External cephalic version at term under Remifentanil perfusion
|
Drug: Remifentanil
Other Name: CAS- NUMBER: 132875-61-7
|
|
Active Comparator: Nitrous oxide
External cephalic version at term under Nitrous oxide inhalation
|
Drug: Nitrous Oxide
Other Name: CAS_NUMBER:10024-97-2
|
Detailed Description:
External cephalic version is a procedure with clear benefits, but its realization is painful for the patient. Studies have shown that this pain limits external cephalic version efforts and therefore it negatively influences its success rate. In addition, any painful procedure has worse acceptance by patients so that its implementation is slow and not always universal. In this context, measures to reduce this pain could improve the success rate and acceptance of the procedure. All studies that have focused on reducing pain in external cephalic version have been made with regional anaesthetic techniques, epidural or spinal analgesia. Given the heterogeneity and the small number of studies there is still no conclusive data to make recommendations for regional anaesthesia in the external cephalic version. The introduction of regional anaesthesia can bring benefits to the version but it is not without drawbacks. This is an invasive anaesthetic technique that can reduce the security of the procedure and lead to longer hospital stay for the patient by the blockade that produces in the lower extremities. This in turn is associated with increased discomfort and costs of the procedure.
Cruces University Hospital has wide experience in carrying out external cephalic version procedures, being one of Spanish leading hospitals in terms of number of procedures and success rate. Currently external cephalic version procedures include analgesic support using nitrous oxide due to the combination of moderate analgesic activity and substantial ease of use.
The investigators belief is that the use of an opioid with advantageous pharmacokinetic properties and powerful analgesic effect as an adjunctive therapy during the course of external cephalic version procedures may become an efficacious and safe alternative, leading to increased pain relief and improved external cephalic version success rates. Its use requires, however, specific personnel and organizational facilities such as access to anesthetic support that can impede its widespread use. Therefore, the investigators is committed to explore feasibility and practical implementation factors as well as comparative efficacy and safety of this approach in breech presentation.
The investigators conducted a study to evaluate the effect of nitrous oxide as an adjunctive to external cephalic version and we observed a slight decrease in patient reported pain (visual analogous scale), with no effect on the rate of success. Currently, in the protocol of Cruces University Hospital the administration of nitrous oxide during the manoeuvres of the external cephalic version is routine practice. The investigators consider that the analgesic remifentanil is a better option for the external cephalic version than nitrous oxide by the combination of rapid onset of effect, with analgesic potency similar to regional anaesthesia and rapid metabolism that prevents their accumulation in tissues.
The lack of existing evidence on this issue, hence, prompts the investigators to conduct this pilot clinical trial aimed to assess scientific as well as logistical aspects involved in the performance of external cephalic version in breech presentation.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pregnancy at term (≥ 37 weeks)
- singleton foetus in breech 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 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;
- 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).
Contacts and Locations| Contact: JORGE BURGOS, PROFESSOR | 94 600 6000 ext 6354 | jburgoss@sego.es |
| Spain | |
| Hospital Universitario Cruces | Recruiting |
| Barakaldo, Bizkaia, Spain, 48903 | |
| Contact: JORGE BURGOS, PROFESSOR 946006000 ext 6354 jburgoss@sego.es | |
| Principal Investigator: JORGE BURGOS | |
More Information
No publications provided
| Responsible Party: | Jorge Burgos, PROFESSOR, Hospital de Cruces |
| ClinicalTrials.gov Identifier: | NCT01735669 History of Changes |
| Other Study ID Numbers: | REMIVER |
| Study First Received: | November 20, 2012 |
| Last Updated: | November 25, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital de Cruces:
|
Remifentanil Breech presentation Nitrous oxide |
Pregnancy complications Caesarean section Fetal version |
Additional relevant MeSH terms:
|
Pregnancy Complications Respiratory Aspiration Breech Presentation Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Obstetric Labor Complications Nitrous Oxide Remifentanil Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Analgesics, Opioid Hypnotics and Sedatives Anesthetics, Intravenous |
ClinicalTrials.gov processed this record on June 18, 2013