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Gastric Emptying of Water in Obese Term Pregnant Women

K

Kangbuk Samsung Hospital

Status

Terminated

Conditions

Pregnancy Related

Treatments

Other: Water

Study type

Observational

Funder types

Other

Identifiers

NCT04116749
KBSMC 2019-08-039

Details and patient eligibility

About

It has been believed that the risk of pulmonary aspiration in term pregnant women is increased, and should be considered that all term pregnant women to have "full stomach". Recently, gastric ultrasound has been adopted as a useful tool for quantitative and qualitative assessment of stomach before anesthesia, and predict the risk of pulmonary aspiration.

Although, both the obesity and pregnancy are known to be the risk of pulmonary aspiration, it is suggested in the American Society of Anesthesiology fasting guidelines, that the same fasting time should be applied in the obese and non-obese parturients. However, this was based on one study done in a small (10) numbers of volunteers.

Therefore, the investigators aimed to compare the gastric antral cross-sectional area in both obese and non-obese term pregnant women, scheduled for elective cesarean section.

Full description

This study is a prospective, observational study. 42 term (≥37 weeks) pregnant, non-laboring adult women scheduled for cesarean delivery will be included in the study. They will be allowed to drink water freely, until 2 hours before the anesthesia. Gastric ultrasound will be performed in 21 non-obese women, and 21 obese women. The obesity is defined by the body mass index at term.

Enrollment

26 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Non laboring, term (≥37 weeks) pregnant women
  • Scheduled for elective cesarean section
  • aged ≥ 18 years old
  • American Society of Anesthesiology physical class 1-3

Exclusion criteria

  • multigestational pregnancy
  • diagnosed for delayed gastric emptying (GERD, gastrointestinal disease)
  • diabetes

Trial design

26 participants in 2 patient groups

Non-obese women
Description:
body mass index lower than 30 (kg/m\^2) at term
Treatment:
Other: Water
Obese women
Description:
body mass index equal or greater than 30 (kg/m\^2) at term
Treatment:
Other: Water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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