LaborNCT03242356
Oral Feeding During Established Labor at Our Institution
An observational study of Labor, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor
- What is being tested?
- Questionnaire to assess of the application of the current French guidelines as to fasting during labor.
- Type of treatment
- Pill or oral medicine
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2017to 25 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All adult woman who has been in labor in our hospital
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Labor
- Being tested
- Questionnaire to assess of the application of the current French guidelines as to fasting during labor.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire to assess of the application of the current French guidelines as to fasting during labor.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of parturients who declared to have ingested clear fluid during the labor.
Measured: The survey will be completed within 2 hours following the delivery
Secondary outcomes (10)
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
Measured: The survey will be completed within 2 hours following the delivery
Specify the type of liquid ingested (water or sweet liquid) and its volume
Nature and volume of liquids ingested
Measured: The survey will be completed within 2 hours following the delivery
Specify the frequency of ingestion of solid foods during labor
Nature and quantity of ingested solids
Measured: The survey will be completed within 2 hours following the delivery
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)
Measured: The survey will be completed within 2 hours following the delivery
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)
Measured: The survey will be completed within 2 hours following the delivery
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)
Measured: 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
Incidence of at least one episode of nausea and vomiting during labor
Measured: 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
Analysis of independent risk factors for the patient's strict fasting during labor
Measured: The survey will be completed within 2 hours following the delivery
Indicate the total duration of fast and solid fasting before birth
Total duration of liquid fasting and solids preceding birth
Measured: The survey will be completed within 2 hours following the delivery
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
Measured: The survey will be completed within 2 hours following the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start25 Aug 2017
- Primary completion25 Nov 2017
- Study completion25 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242356
- Sponsor's protocol ID
- 69HCL17_0454
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)
- ClinicalTrials.gov ID
- NCT03242356
- Acronym / sponsor ID
- 69HCL17_0454
- Conditions
- Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 25 Nov 2017 (actual)
- Study completion
- 25 Nov 2017 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All adult woman who has been in labor in our hospital
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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
10 secondary outcomes
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
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
Specify the frequency of ingestion of solid foods during labor
Time frame: 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
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
Evaluate women's satisfaction with the fasting instructions received
Time frame: 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
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
Indicate the total duration of fast and solid fasting before birth
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.