- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03242356
Oral Feeding During Established Labor at Our Institution
12 april 2018 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
195
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bron, Frankrike, 69677
- Hôpital Femme Mère Enfant
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Rate of parturients who declared to have ingested clear fluid during the labor.
Tidsram: The survey will be completed within 2 hours following the delivery
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The survey will be completed within 2 hours following the delivery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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Evaluate women's satisfaction with the fasting instructions received
Tidsram: 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)
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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
Tidsram: 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
Tidsram: 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
|
|
Indicate the total duration of fast and solid fasting before birth
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 augusti 2017
Primärt slutförande (Faktisk)
25 november 2017
Avslutad studie (Faktisk)
25 november 2017
Studieregistreringsdatum
Först inskickad
4 augusti 2017
Först inskickad som uppfyllde QC-kriterierna
7 augusti 2017
Första postat (Faktisk)
8 augusti 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 april 2018
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 69HCL17_0454
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