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Gastric Emptying During the Labour (VGObstetric)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490682
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Current recommendations permit the ingestion of all clear fluids (water, apple juice, black coffee..) during labour. However, regarding food during labour, the recommendations vary. British and European guidelines permit the ingestion of low-residue food during labour whilst guidelines from the United States prohibit having any solid food during labour. The reason for this variation in recommendations is the lack of data on gastric emptying during labour with a conservative approach adopted due to the fear of delayed gastric emptying increasing the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down during labour, using a validated, non-invasive ultrasound method, in three groups of women : Women in labour (Parturient group), women in the third trimester of pregnancy (Pregnant group) and women who are not currently pregnant (Non-pregnant control group). The investigator propose the hypothesis that the gastric emptying of a light, solid meal is slowed by 30% during labour.

Condition or disease Intervention/treatment Phase
Pregnancy Healthy Volunteers Parturition Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Labour on the Gastric Emptying of a Light Meal
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : May 26, 2019
Actual Study Completion Date : May 26, 2019

Arm Intervention/treatment
Active Comparator: Non-pregnant control
adult females aged less than 40 years, not currently pregnant, without significant medical history (American Society of Anesthesiologists ASA 1), fasting for at least 6 hours for solids and 1 hour for clear fluids.
Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.
Each participant will be placed on a table, in the semi-recumbent position with elevation of the head at 45° and a first ultrasound examination will be performed. After that, the participant will be invited to eat a test meal (flavoured yoghurt) in 5 minutes. An ultrasound examination of the antrum allowing measurement of the antral area will be performed at 15, 60, 90 and 120 minutes after the end of the ingestion of the test meal. The participant must stay in the semi-recumbent position during the total duration of the study. The non-invasive ultrasound measurement, of the antral cross-sectional area is performed using a Sonosite ultrasound equiped with a 2 -5.5MHz probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing by the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula : Antral area = π x D1 x D2 / 4.

Active Comparator: Pregnant control
adult females aged less than 40 years, pregnant in the third trimester (gestation greater than 32 weeks on the day of the study) according to dates and the calculation of term established at the start of the pregnancy by an obstetrician, without significant medical history (American Society of Anesthesiologists ASA 1), fasting for at least 6 hours for solids and I hour for clear fluids.
Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.
Each participant will be placed on a table, in the semi-recumbent position with elevation of the head at 45° and a first ultrasound examination will be performed. After that, the participant will be invited to eat a test meal (flavoured yoghurt) in 5 minutes. An ultrasound examination of the antrum allowing measurement of the antral area will be performed at 15, 60, 90 and 120 minutes after the end of the ingestion of the test meal. The participant must stay in the semi-recumbent position during the total duration of the study. The non-invasive ultrasound measurement, of the antral cross-sectional area is performed using a Sonosite ultrasound equiped with a 2 -5.5MHz probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing by the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula : Antral area = π x D1 x D2 / 4.

Experimental: Parturient
adult females aged less than 40 years, without significant medical history (American Society of Anesthesiologists ASA 1), in labour in the delivery suite, with a working epidural, having consumed solid food more than 6 hours before inclusion in the study and clear fluids more than 1 hour before inclusion in the study, and allowed to ingest solids during labour (cervical dilatation strictly less than 8cm) conforming to local protocols.
Other: Ultrasound assessment of gastric emptying of a flavoured yoghourt.
Each participant will be placed on a table, in the semi-recumbent position with elevation of the head at 45° and a first ultrasound examination will be performed. After that, the participant will be invited to eat a test meal (flavoured yoghurt) in 5 minutes. An ultrasound examination of the antrum allowing measurement of the antral area will be performed at 15, 60, 90 and 120 minutes after the end of the ingestion of the test meal. The participant must stay in the semi-recumbent position during the total duration of the study. The non-invasive ultrasound measurement, of the antral cross-sectional area is performed using a Sonosite ultrasound equiped with a 2 -5.5MHz probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing by the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula : Antral area = π x D1 x D2 / 4.




Primary Outcome Measures :
  1. determination of the rate of gastric emptying of a light meal in the 3 groups of women [ Time Frame: 15 min after the ingestion of a flavoured yoghurt ]
    The rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 90 min / Antral area at 15 min)-1] x 100

  2. determination of the rate of gastric emptying of a light meal in the 3 groups of women [ Time Frame: 90 min after the ingestion of a flavoured yoghurt ]
    The rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 90 min / Antral area at 15 min)-1] x 100


Secondary Outcome Measures :
  1. Comparison of the rate of gastric emptying between the Control group and the Pregnancy group [ Time Frame: 15 min after the ingestion of a flavoured yoghurt ]
    The rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 90 min / Antral area at 15 min)-1] x 100

  2. Comparison of the rate of gastric emptying between the Control group and the Pregnancy group [ Time Frame: 90 min after the ingestion of a flavoured yoghurt ]
    The rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 90 min / Antral area at 15 min)-1] x 100

  3. Calculation of the sonographic rate of gastric emptying in the three groups of women. [ Time Frame: 15 min after the ingestion of a flavoured yoghurt ]
    In each group, the rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 60 min / Antral area at 15 min)-1] x 100

  4. Calculation of the sonographic rate of gastric emptying in the three groups of women. [ Time Frame: 60 min after the ingestion of a flavoured yoghurt ]
    In each group, the rate of gastric emptying will be calculated using the following formula : Rate = [(Antral area at 60 min / Antral area at 15 min)-1] x 100

  5. The rate of women having an empty stomach after the ingestion of the test meal in each group. [ Time Frame: 90 min ]
    Empty stomach will be defined by the lack of ultrasound visualization of any content in the semirecumbent position with antral area ≤ 505 mm² in groups Parturient and Pregnancy, and by the lack of visualization of any content with antral area ≤ 340 mm² in the Control group, 90 and 120 min after ingestion of the test meal.

  6. The rate of women having an empty stomach after the ingestion of the test meal in each group. [ Time Frame: 120 min ]
    Empty stomach will be defined by the lack of ultrasound visualization of any content in the semirecumbent position with antral area ≤ 505 mm² in groups Parturient and Pregnancy, and by the lack of visualization of any content with antral area ≤ 340 mm² in the Control group, 90 and 120 min after ingestion of the test meal.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Informed consent must have been signed. The last consumption of solids will have taken place more than 6 hours before the start of the study, the last consumption of clear fluids will have taken place more than 1 hour before the start of the study, in the three groups.

  • Non-pregnant control group : adult females less than 40 years old with no significant medical history (American Society of Anesthesiologists ASA class 1)
  • Pregnant group : adult females less than 40 years old with no significant medical history (American Society of Anesthesiologists ASA class 1) in the third trimester of pregnancy (gestation greater than 32 weeks on the day of the study).
  • Parturient group : adult females less than 40 years old with no significant medical history (American Society of Anesthesiologists ASA class 1, in labour in the delivery room, receiving effective epidural analgesia, having an empty stomach on the initial ultrasound examination, and authorised to ingest solid foods during labour (cervical dilatation strictly less than 8cm) according to local guidelines.

Exclusion Criteria:

  • Refusal to participate in this study
  • Patient unable to speak French
  • Oesophageal, duodenal or gastric medical or surgical history Pregnant group : Threatened premature labour, multiple pregnancy, pathological pregnancy

Parturient group :

  • gestation less than 38 weeks
  • multiple pregnancy
  • All pathology of the pregnancy or complication during labour
  • Delivery
  • Patient admission for therapeutic interruption of the pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490682


Locations
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France
Hospices Civils de Lyon
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Lionel BOUVET, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03490682    
Other Study ID Numbers: 69HCL17_0863
2017-A03605-48 ( Other Identifier: ID-RCB )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No