Pregnancy Complications Clinical Trial
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
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.
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 non-cephalic 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 non-cephalic presentation.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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