Mallampati Score Before and After Cesarean Delivery (MSBAC)

May 15, 2017 updated by: Lisa Sangkum, Ramathibodi Hospital

Ramathibodi Hospital, Mahidol University

Mallampati class change has not been well evaluated during the cesarean delivery. Various factors regarding to cesarean delivery might influence this changes. The aim of this study was to evaluate the Mallampati class before and after cesarean delivery and to identify predictive factors of the changes..

Study Type: Observational Cross-sectional study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mallampati class, thyromental distance, neck circumference, and upper lip bite test were evaluated at four time intervals : during pre-anesthetic visit (T0), 1-hour (T1), 6-hour (T2), and 24-hour after delivery (T3).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Thai pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37 weeks giving written informed consent.

Description

Inclusion Criteria:

  • Pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37 weeks giving written informed consent.
  • Initial Mallampati score ≤ III
  • Normal clinical course

Exclusion Criteria:

  • Patient who denied to participate the study
  • Initial Mallampati score ≥ IV
  • Age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate Modified Mallampati score changes before and after cesarean delivery
Time Frame: up tp 2 days
Modified Mallampati score (score 1-4;1= easy airway and 4 = difficult airway) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
up tp 2 days
Evaluate thyromental distance changes before and after cesarean delivery
Time Frame: up tp 2 days
thyromental distance (centimeter) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
up tp 2 days
Evaluate upper lip bite score changes before and after cesarean delivery
Time Frame: up to 2 days
Upper lip bite score (score 1-4; 1 = easy airway and 4 = difficult airway) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
up to 2 days
Evaluate neck circumference changes before and after cesarean delivery
Time Frame: up to 2 days
Neck circumference (centimeter) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
up to 2 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxytocin dosage and Alteration of Modified mallampati score
Time Frame: up tp 2 days
Evaluate the percentage of patients whose mallampati score increase from baseline between patient who recieved high dose oxytocin (≥ 0.6 U/minl) and low dose oxytocin ( <0.6 U/min )
up tp 2 days
Intraoperative intravenous fluid and Alteration of Modified mallampati score
Time Frame: up tp 2 days
Evaluate the percentage of patients whose mallampati score increase from baseline between patient who recieved intravenous fluid ≥ 2000 ml and < 2000 ml
up tp 2 days
Estimate blood loss and Alteration of Modified mallampati score
Time Frame: up tp 2 days
Evaluate the percentage of patients whose mallampati score increase from baseline between patient whose estimate blood loss≥ 1000 ml and < 1000 ml
up tp 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ramaanes2559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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