MedTrace Logo

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

NCT01735669 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-02-18

No results posted yet for this study

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.

Conditions

  • Non-cephalic Presentation
  • Inhalation of Nitrous Oxide
  • Pregnancy Complications
  • Complications; Cesarean Section
  • Fetus or Neonate Affected by External Version Before Labor

Interventions

DRUG

Remifentanil

DRUG

Nitrous Oxide

Sponsors & Collaborators

  • Hospital de Cruces

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-04-30
Completion
2014-01-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01735669 on ClinicalTrials.gov