NCT01735669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

November 20, 2012

Last Update Submit

February 14, 2015

Conditions

Non-cephalic PresentationInhalation of Nitrous OxidePregnancy ComplicationsComplications; Cesarean SectionFetus or Neonate Affected by External Version Before Labor

Keywords

RemifentanilBreech presentationNitrous oxidePregnancy complicationsCaesarean sectionFetal version

Outcome Measures

Primary Outcomes (1)

  • Success rate of ECV in singleton pregnancies in breech presentation at term

    5 minutes

Secondary Outcomes (8)

  • Rate of adverse events and severity

    30 days

  • Pain Scores on the Visual Analog Scale

    60 min

  • Rate of non-cephalic presentation in the delivery

    30 days

  • Caesarean rate

    30 days

  • Rate of women who would recommend the procedure

    60 min

  • +3 more secondary outcomes

Study Arms (2)

Remifentanil

EXPERIMENTAL

External cephalic version at term under Remifentanil perfusion

Drug: Remifentanil

Nitrous oxide

ACTIVE COMPARATOR

External cephalic version at term under Nitrous oxide inhalation

Drug: Nitrous Oxide

Interventions

RemifentanilDRUG
Also known as: CAS- NUMBER: 132875-61-7
Remifentanil
Nitrous OxideDRUG
Also known as: CAS_NUMBER:10024-97-2
Nitrous oxide

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnancy at term (≥ 37 weeks)
  • singleton foetus in non-cephalic 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

MeSH Terms

Conditions

Pregnancy ComplicationsBreech Presentation

Interventions

RemifentanilNitrous Oxide

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor Complications

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 28, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2013

Study Completion

January 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

ES(1)