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Mallampati Score Before and After Cesarean Delivery (MSBAC)

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ClinicalTrials.gov Identifier: NCT02687282
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Lisa Sangkum, Ramathibodi Hospital

Brief Summary:

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


Condition or disease Intervention/treatment
Alteration of Modified Mallampati Score Other: Evaluate upper airway changes

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 : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Ramathibodi Hospital, Mahidol University
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section


Intervention Details:
  • Other: Evaluate upper airway changes
    Evaluate upper airway changes at several point of time before and after cesarean delivery


Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)


Secondary Outcome Measures :
  1. 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 )

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Publications:

Responsible Party: Lisa Sangkum, Principle investigator, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02687282     History of Changes
Other Study ID Numbers: Ramaanes2559
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lisa Sangkum, Ramathibodi Hospital:
Modified Mallampati score
Cesarean delivery