Oral Feeding During Established Labor at Our Institution
1 other identifier
observational
195
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2017
CompletedApril 13, 2018
August 1, 2017
3 months
August 4, 2017
April 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 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
The survey will be completed within 2 hours following the delivery
Specify the type of liquid ingested (water or sweet liquid) and its volume
The survey will be completed within 2 hours following the delivery
Specify the frequency of ingestion of solid foods during labor
The survey will be completed within 2 hours following the delivery
Assess the degree of discomfort associated with thirst that was felt during labor
The survey will be completed within 2 hours following the delivery
Assess the degree of discomfort associated with hunger that was felt during labor
The survey will be completed within 2 hours following the delivery
- +5 more secondary outcomes
Interventions
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.
Eligibility Criteria
All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor
You may qualify if:
- All adult woman who has been in labor in our hospital
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
hopital Femme Mère Enfant
Bron, 69677, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2017
First Posted
August 8, 2017
Study Start
August 25, 2017
Primary Completion
November 25, 2017
Study Completion
November 25, 2017
Last Updated
April 13, 2018
Record last verified: 2017-08