Oral Feeding During Established Labor at Our Institution

Labor Clinical Trial

Official title:

Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242356
• Other study ID #: 69HCL17_0454
• Status: Completed
• First received: August 4, 2017
• Last updated: April 12, 2018
• Start date: August 25, 2017
• Est. completion date: November 25, 2017

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia. To date, no study assessed how these guidelines are followed in clinical practice. This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: November 25, 2017
• Est. primary completion date: November 25, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult woman who has been in labor in our hospital

Exclusion Criteria:

• Patient refusal

• Elective cesarean section, or emergency cesarean section in a woman not in labor

• Intrauterine fetal death

• Therapeutic abortion

• Patient consent not available (for example, in case of severe post-partum hemorrhage)

Related Conditions & MeSH terms

• Labor

Intervention

Other:
• Questionnaire to assess of the application of the current French guidelines as to fasting during labor.
Questionnaire focuses on : oral intake of clear fluid during the labor oral intake of solid meal during the labor fasting duration for solid and liquids instruction received as to fasting during labor, nature of these instructions, and who given the instruction (midwife, nurse anesthetist, …) discomfort related to thirst during labor discomfort related to hunger during labor We will also record several medical data as to the course of pregnancy and delivery, analgesia technique, history and characteristics of the parturient.

Locations

Country	Name	City	State
France	hopital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of parturients who declared to have ingested clear fluid during the labor.		The survey will be completed within 2 hours following the delivery
Secondary	Determine the instructions given by health professionals, their spontaneous or non-spontaneous character and the information related to the given fast, according to the parturient	Determine the instructions given by health professionals, whether they are spontaneous or not	The survey will be completed within 2 hours following the delivery
Secondary	Specify the type of liquid ingested (water or sweet liquid) and its volume	Nature and volume of liquids ingested	The survey will be completed within 2 hours following the delivery
Secondary	Specify the frequency of ingestion of solid foods during labor	Nature and quantity of ingested solids	The survey will be completed within 2 hours following the delivery
Secondary	Assess the degree of discomfort associated with thirst that was felt during labor	Degree of discomfort related to thirst on a simple numeric scale (0: no discomfort at 10: very uncomfortable)	The survey will be completed within 2 hours following the delivery
Secondary	Assess the degree of discomfort associated with hunger that was felt during labor	Degree of discomfort related to hunger on a simple numeric scale (0: no discomfort at 10: very uncomfortable)	The survey will be completed within 2 hours following the delivery
Secondary	Evaluate women's satisfaction with the fasting instructions received	Satisfaction with fasting instructions given on a simple numerical scale (0: very high dissatisfaction, 10: maximum satisfaction)	The survey will be completed within 2 hours following the delivery
Secondary	Determine if nausea and vomiting are more common in women who have ingested fluids during labor	Incidence of at least one episode of nausea and vomiting during labor	The survey will be completed within 2 hours following the delivery
Secondary	Analyze the factors associated with fasting during work and their concordance with the French recommendations on fasting during labor	Analysis of independent risk factors for the patient's strict fasting during labor	The survey will be completed within 2 hours following the delivery
Secondary	Indicate the total duration of fast and solid fasting before birth	Total duration of liquid fasting and solids preceding birth	The survey will be completed within 2 hours following the delivery
Secondary	Compare fasting instructions received by patients and practices reported by professionals	Fasting instructions received by patients and practices reported by professionals obtained during a practice survey	The survey will be completed within 2 hours following the delivery