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Completed

NCT Number: NCT03242356

Oral Feeding During Established Labor at Our Institution

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).

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Key information

Conditions

Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

hopital Femme Mère Enfant

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2017
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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