Clinical trial NCT03490682: Gastric Emptying During the Labour
Official title: Effect of Labour on the Gastric Emptying of a Light Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Healthy Volunteers
Parturition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 four groups of women : Women in labour with epidural analgesia (Analgesia group), women in labor without any epidural analgesia (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 under epidural analgesia.


Eligibility 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).
* Analgesia 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.
* Parturient group : adult females less than 35 years old with no significant medical history (American Society of Anesthesiologists ASA class 1, in labour in the delivery room, no 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

Analgesia and Parturient groups :

* 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

Primary outcomes:
measure: determination of the rate of gastric emptying of a light meal in the 3 groups of women
timeFrame: 15 min after the ingestion of a flavoured yoghurt
measure: determination of the rate of gastric emptying of a light meal in the 3 groups of women
timeFrame: 90 min after the ingestion of a flavoured yoghurt
Secondary outcomes:
measure: Comparison of the rate of gastric emptying between the Control group and the Pregnancy group
timeFrame: 15 min after the ingestion of a flavoured yoghurt
measure: Comparison of the rate of gastric emptying between the Control group and the Pregnancy group
timeFrame: 90 min after the ingestion of a flavoured yoghurt
measure: Calculation of the sonographic rate of gastric emptying in the three groups of women.
timeFrame: 15 min after the ingestion of a flavoured yoghurt
measure: Calculation of the sonographic rate of gastric emptying in the three groups of women.
timeFrame: 60 min after the ingestion of a flavoured yoghurt
measure: The rate of women having an empty stomach after the ingestion of the test meal in each group.
timeFrame: 90 min
measure: The rate of women having an empty stomach after the ingestion of the test meal in each group.
timeFrame: 120 min
measure: Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group
timeFrame: 15 min after the ingestion of a flavoured yoghurt
measure: Comparison of the rate of gastric emptying between the Analgesia group and the Parturient group
timeFrame: 90 min after the ingestion of a flavoured yoghurt
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Lionel BOUVET, MD
role: PRINCIPAL_INVESTIGATOR
References: