Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Pr

Brief Summary:

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 non-cephalic 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.


Detailed Summary:

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
Sponsor: Hospital de Cruces

Current Primary Outcome: Success rate of ECV in singleton pregnancies in breech presentation at term [ Time Frame: 5 minutes ]

Original Primary Outcome: 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 ]

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


Current Secondary Outcome:

  • Rate of adverse events and severity [ Time Frame: 30 days ]
    Metrics (analysis)
  • Pain Scores on the Visual Analog Scale [ Time Frame: 60 min ]
    Metrics (scale)
  • Rate of non-cephalic presentation in the delivery [ Time Frame: 30 days ]
    Metrics (analysis)
  • Caesarean rate [ Time Frame: 30 days ]
    Metrics (analysis)
  • Rate of women who would recommend the procedure [ Time Frame: 60 min ]
    Metrics (questionnaire)
  • Rate of women who would repeat the procedure [ Time Frame: 60 min ]
    Metrics (questionnaire)
  • Influence of the analgesia in the rate of women who would repeat the procedure [ Time Frame: 60 min ]
    Metrics (questionnaire)
  • Influence of the analgesia in the rate of women who would recommend the procedure [ Time Frame: 60 min ]
    Metrics (questionnaire)


Original Secondary Outcome:

  • Rate of adverse events and severity [ Time Frame: 30 days ]
  • Degree of satisfaction of pregnant women [ Time Frame: 60 min ]
  • Rate of breech presentation in the delivery [ Time Frame: 30 days ]
  • Rate of caesarean section [ Time Frame: 30 days ]


Information By: Hospital de Cruces

Dates:
Date Received: November 20, 2012
Date Started: July 2012
Date Completion:
Last Updated: February 14, 2015
Last Verified: February 2015