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Completed

NCT Number: NCT02687282

Mallampati Score Before and After Cesarean Delivery

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

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluate upper airway changes

Other

Evaluate upper airway changes at several point of time before and after cesarean delivery

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

Ramathibodi Hospital, Mahidol University

Acronym: MSBAC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2016
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.