- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03242356
Oral Feeding During Established Labor at Our Institution
12. april 2018 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
195
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Bron, Frankrig, 69677
- Hopital Femme Mere Enfant
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Rate of parturients who declared to have ingested clear fluid during the labor.
Tidsramme: The survey will be completed within 2 hours following the delivery
|
The survey will be completed within 2 hours following the delivery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: The survey will be completed within 2 hours following the delivery
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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
Tidsramme: The survey will be completed within 2 hours following the delivery
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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
|
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Determine if nausea and vomiting are more common in women who have ingested fluids during labor
Tidsramme: The survey will be completed within 2 hours following the delivery
|
Incidence of at least one episode of nausea and vomiting during labor
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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
Tidsramme: The survey will be completed within 2 hours following the delivery
|
Analysis of independent risk factors for the patient's strict fasting during labor
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The survey will be completed within 2 hours following the delivery
|
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Indicate the total duration of fast and solid fasting before birth
Tidsramme: The survey will be completed within 2 hours following the delivery
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Total duration of liquid fasting and solids preceding birth
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The survey will be completed within 2 hours following the delivery
|
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Compare fasting instructions received by patients and practices reported by professionals
Tidsramme: 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
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The survey will be completed within 2 hours following the delivery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. august 2017
Primær færdiggørelse (Faktiske)
25. november 2017
Studieafslutning (Faktiske)
25. november 2017
Datoer for studieregistrering
Først indsendt
4. august 2017
Først indsendt, der opfyldte QC-kriterier
7. august 2017
Først opslået (Faktiske)
8. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. april 2018
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 69HCL17_0454
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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