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OpenTrials
Completed

NCT Number: NCT01087047

Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.

Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.

The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.

Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.

Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Armand Trousseau University Hospital, Paris, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy will be invited to participate in the study.
  • Women are eligible for the study if they are:
  • healthy (no previous disease, hypertension, nor obesity),
  • 18 years or more
  • with a singleton live fetus at the routine ultrasound scan
  • with a normal pregnancy.

Exclusion criteria

  • Pregnancy complications
  • Multiple pregnancy
  • High risk for preterm labor
  • Underlying diseases that could interfere with the results (such as pre-existing upper airway problems) and participation.

Treatment and study plan

Acoustic reflection method

Device

An acoustic reflection device gives the longitudinal cross-sectional area profile along airways. It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.

Primary outcomes

  1. Physiological modifications during pregnancy and acoustic reflection method

    Time frame: 6 months

    Main aim: to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy. Women enrolled in the study will undergo an acoustic recording during:

    • the 1st, 2d, and 3d trimester of pregnancy
    • two days after delivery
    • one month after delivery

Secondary outcomes

  1. MRI and acoustic reflection method

    Time frame: 6 months

    Secondary aim: a single acoustic recording will be proposed to 10 pregnant women undergoing an MRI for obstetrical purpose.

    The estimated caliber of the upper airways by MRI and acoustic method will be compared.

Sponsors and collaborators

Lead sponsor

Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: MAVAG

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2010
Registry last updated
Jun 12, 2012

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.

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