- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03242356
Oral Feeding During Established Labor at Our Institution
12. april 2018 oppdatert 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).
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
195
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Bron, Frankrike, 69677
- Hôpital Femme Mère Enfant
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
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 |
Tiltaksbeskrivelse |
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
|
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
|
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
Tidsramme: 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
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
|
The survey will be completed within 2 hours following the delivery
|
|
Indicate the total duration of fast and solid fasting before birth
Tidsramme: 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
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
|
The survey will be completed within 2 hours following the delivery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. august 2017
Primær fullføring (Faktiske)
25. november 2017
Studiet fullført (Faktiske)
25. november 2017
Datoer for studieregistrering
Først innsendt
4. august 2017
Først innsendt som oppfylte QC-kriteriene
7. august 2017
Først lagt ut (Faktiske)
8. august 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. april 2018
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 69HCL17_0454
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Arbeid
-
Kayseri Education and Research HospitalFullført
-
Ricardo A Gutierrez Ramirez, MD, MSc, FACOGFullførtCervikal modning | Levering med keisersnitt | Labor i latent faseHonduras
-
King Khalid University HospitalKing Saud UniversityFullførtVurder kvinners bevissthet og frykt om EDA for LaborSaudi-Arabia
-
Assiut UniversityFullført
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)FullførtLabor i latent fase
-
Aydin Adnan Menderes UniversityFullførtArbeidsvarighet | Labor Bain | og Fødselsfornøyelse under Fysiologisk Vaginal FødselTyrkia (Türkiye)
-
Beni-Suef UniversityCairo UniversityRekrutteringLidelse i fostervannshulen og/eller membranenEgypt