NCT01278238

Brief Summary

The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women. The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

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

January 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 11, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

January 14, 2011

Last Update Submit

January 9, 2013

Conditions

Caesarean Section

Keywords

HypotensionCaesarean sectionSpinal anaesthesiaLower limb compression / wrappingPhenylephrine

Outcome Measures

Primary Outcomes (1)

  • Invasive arterial bloodpressure

    Until end of operation, up to roughly 1 hour

Secondary Outcomes (4)

  • pH value from umbilical vessels of the newborn

    straight after delivery

  • APGAR score of the newborn

    1 + 5 + 10 minutes after delivery

  • Need for rescue pressor (ephedrine, phenylephrine)

    Until end of operation, roughly 1 hour

  • Cardiac Output

    Until end of operation, roughly 1 hour

Study Arms (3)

Phenylephrine

ACTIVE COMPARATOR
Drug: Phenylephrine

Lower limb compression

ACTIVE COMPARATOR
Device: Lower limb compression

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

PhenylephrineDRUG

Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

Phenylephrine
Lower limb compressionDEVICE

Tight bandaging of lower extremity up to hips with compression bandages

Lower limb compression
PlaceboOTHER

Neither phenylephrine nor lower limb bandaging

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm

You may not qualify if:

  • Any form of disease or anomalities:
  • Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bærum Sykehus

Rud, Akershus, 1309, Norway

Location

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Jana Christine Kuhn, Dr.med.

    Bærum sykehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

January 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 11, 2013

Record last verified: 2013-01

Locations

NO(1)