- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242356
Oral Feeding During Established Labor at Our Institution
April 12, 2018 updated by: Hospices Civils de Lyon
Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
195
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France, 69677
- Hopital Femme Mere Enfant
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of parturients who declared to have ingested clear fluid during the labor.
Time Frame: The survey will be completed within 2 hours following the delivery
|
The survey will be completed within 2 hours following the delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: The survey will be completed within 2 hours following the delivery
|
Determine the instructions given by health professionals, whether they are spontaneous or not
|
The survey will be completed within 2 hours following the delivery
|
|
Specify the type of liquid ingested (water or sweet liquid) and its volume
Time Frame: The survey will be completed within 2 hours following the delivery
|
Nature and volume of liquids ingested
|
The survey will be completed within 2 hours following the delivery
|
|
Specify the frequency of ingestion of solid foods during labor
Time Frame: The survey will be completed within 2 hours following the delivery
|
Nature and quantity of ingested solids
|
The survey will be completed within 2 hours following the delivery
|
|
Assess the degree of discomfort associated with thirst that was felt during labor
Time Frame: The survey will be completed within 2 hours following the delivery
|
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
|
|
Assess the degree of discomfort associated with hunger that was felt during labor
Time Frame: The survey will be completed within 2 hours following the delivery
|
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
|
|
Evaluate women's satisfaction with the fasting instructions received
Time Frame: The survey will be completed within 2 hours following the delivery
|
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
|
|
Determine if nausea and vomiting are more common in women who have ingested fluids during labor
Time Frame: The survey will be completed within 2 hours following the delivery
|
Incidence of at least one episode of nausea and vomiting during labor
|
The survey will be completed within 2 hours following the delivery
|
|
Analyze the factors associated with fasting during work and their concordance with the French recommendations on fasting during labor
Time Frame: The survey will be completed within 2 hours following the delivery
|
Analysis of independent risk factors for the patient's strict fasting during labor
|
The survey will be completed within 2 hours following the delivery
|
|
Indicate the total duration of fast and solid fasting before birth
Time Frame: The survey will be completed within 2 hours following the delivery
|
Total duration of liquid fasting and solids preceding birth
|
The survey will be completed within 2 hours following the delivery
|
|
Compare fasting instructions received by patients and practices reported by professionals
Time Frame: The survey will be completed within 2 hours following the delivery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2017
Primary Completion (Actual)
November 25, 2017
Study Completion (Actual)
November 25, 2017
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 8, 2017
Study Record Updates
Last Update Posted (Actual)
April 13, 2018
Last Update Submitted That Met QC Criteria
April 12, 2018
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL17_0454
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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