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NCT Number: NCT01982513

Influence of the Method of Alleviation of Aorto-Caval Compression on the Trans-Hepatic Ultrasound-Assessed Inferior Vena Cava Diameter In Pregnant Patients

Cardiac arrest during pregnancy is rare but may result in poor maternal and fetal outcome. Because of its rare occurrence and ethical issues this topic is not very well studied and many questions pertaining to maternal resuscitation remain unanswered. One of the challenging aspects of cardiopulmonary resuscitation in a term pregnant patient is the ideal positioning during chest compressions. International societies have made recommendations regarding management of pregnant patients during cardiac arrest. They advocate the use of left lateral position with 30 degrees tilt or manual uterine displacement. However these recommendations are not based on high level of evidence. Ultrasound has been used to visualize the change in diameter of great vessels to determine the volume status or adequacy of blood circulation of these patients. This approach can be used to study the adequacy of blood circulation of pregnant patients in different positions. The objective of this study is to compare the change in Inferior vena cava diameter obtained with pregnant women in either the left lateral tilt or in the supine position with a manual uterine displacement, compared to the left lateral position and the supine position.

Our hypothesis is that the inferior vena cava diameter obtained in the supine position with manual left uterine displacement would be larger as compared to that obtained with women positioned with a 30-degree tilt.

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Key information

Conditions

Pregnancy Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

Using the non-invasive technology of ultrasound we will be able to determine the degree of aorto-caval compression in pregnant women placed in different positions. The results of this study will help us to determine the optimal patient positioning for each individual. This in future may help us in improving outcomes not only during labor and anesthesia, but also during maternal resuscitation in critical cases.

The results of this study will help us to determine the best technique to minimize aorto-caval compression in the term pregnant patient. The results of this study will be useful to establish firm maternal resuscitation guidelines. We will be able to determine the optimal maternal position during cardiopulmonary resuscitation and this may improve both maternal and fetal resuscitation outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA I or II
  • Term pregnancy (36-40 weeks)
  • Singleton pregnancy

Exclusion criteria

  • Patients with known cardiac disease, severe preeclampsia on medication
  • Multiple gestation
  • Breech presentation
  • Patients unable to comply with the 4 positions (left lateral, left tilt, supine and supine with manual displacement)
  • Patients unable or unwilling to consent

Treatment and study plan

Ultrasound

Device

The IVC will be visualized and images obtained using the intercostal window in both longitudinal and transverse planes.

Primary outcomes

  1. IVC maximum diameter

    Time frame: 20 minutes

    The IVC maximum diameter in each position (measured during expiration).

Secondary outcomes

  1. Fetal Heart Rate

    Time frame: 20 minutes

    The fetal heart rate will be monitored during the last minute of observation in each position.

  2. Maternal vitals

    Time frame: 20 minutes

    Maternal blood pressure and heart rate will be monitored during the last minute of observation in each position.

  3. IVC minimum diameter

    Time frame: 20 minutes

    The IVC minimum diameter in each position (measured during inspiration).

  4. IVC Index

    Time frame: 20 minutes

    IVC index (IVI) = IVC(max)-IVC (min)/IVC(max)

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Influence of the Method of Alleviation of Aorto-Caval Compression on the Trans-Hepatic Ultrasound-Assessed Inferior Vena Cava Diameter In Pregnant Patients: An Observational Study of the Left Lateral Tilt and of the Left Uterine Displacement

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 13, 2013
Registry last updated
Jun 4, 2014

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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