NCT02654067

Brief Summary

Pregnant patients mallampati class scores will be examined throughout pregnancy

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

November 25, 2015

Last Update Submit

September 18, 2019

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Mallampati score changes during pregnancy

    mallampati scores classification from 1 to 4

    40 weeks

Interventions

photographPROCEDURE

photograph of airway

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients

You may qualify if:

  • pregnant
  • at least 18 years of age

You may not qualify if:

  • refusal of consent
  • known difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Location

Related Publications (3)

  • Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.

    PMID: 4027773RESULT

  • Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.

    PMID: 18292672RESULT

  • Pilkington S, Carli F, Dakin MJ, Romney M, De Witt KA, Dore CJ, Cormack RS. Increase in Mallampati score during pregnancy. Br J Anaesth. 1995 Jun;74(6):638-42. doi: 10.1093/bja/74.6.638.

    PMID: 7640115RESULT

MeSH Terms

Interventions

Moire Topography

Intervention Hierarchy (Ancestors)

PhotogrammetryPhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInterferometryInvestigative Techniques

Study Officials

  • Julian Robinson, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Obstetrics

Study Record Dates

First Submitted

November 25, 2015

First Posted

January 13, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)