- ICH GCP
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- Essai clinique NCT03242356
Oral Feeding During Established Labor at Our Institution
12 avril 2018 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
195
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Bron, France, 69677
- Hopital Femme Mere Enfant
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor
La 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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Rate of parturients who declared to have ingested clear fluid during the labor.
Délai: The survey will be completed within 2 hours following the delivery
|
The survey will be completed within 2 hours following the delivery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 août 2017
Achèvement primaire (Réel)
25 novembre 2017
Achèvement de l'étude (Réel)
25 novembre 2017
Dates d'inscription aux études
Première soumission
4 août 2017
Première soumission répondant aux critères de contrôle qualité
7 août 2017
Première publication (Réel)
8 août 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 avril 2018
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 69HCL17_0454
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .