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Early Feeding After A Cesarean Delivery Hastens Recovery Time for Bowel Function

18. mars 2015 oppdatert av: The University of Texas Medical Branch, Galveston

Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial

After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached for participation in the study. The study informed consent will be obtained. The study's time frame inclusive will be from 2013 till 2016.

Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.

Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be performed using a computer generated random list of numbers assigning patients to the 2 groups of the study. This list of random number assignments will be kept secure in an opaque envelope until the end of the study. Patients in the Early group will be started on regular diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO 12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as tolerated, i.e. if clears were tolerated or flatus or bowel movement occurred, patients will be started on solid foods. If diet not tolerated, a full liquid diet will be given instead. Consequently if patient tolerated full liquid diet, a regular diet will be then initiated. Patients will be discharged home only if they tolerate solid food with absence of emesis, have flatus or bowel movement. Time Zero is defined as time of skin incision.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached by Principal investigator or any of the co-investigators for participation in the study during the the preoperative visit which coincides with the same day of scheduled cesarean in a private patient room. . Prospective subjects will be presenting for their preoperative appointment (same day of scheduled cesarean delivery) in labor and delivery and will be asked to participate in the study. The study will be explained as in the consent form and if agreed patients will elect either to or not to participate in the study after all risks and benefits are explained. Data to be collected will consist of time in minutes of passing flatus, time in minutes of having a bowel movement, hospital length of stay, postoperative nausea, vomiting and presence of ileus (unable to tolerate diet, abdominal distention, no bowel movement nor flatus, abdominal x-ray demonstrating air/fluid levels in bowel). Patients will be contacted once to twice a day for assessment of data points mentioned above. If elected to participate consents will be obtained. Randomization will be done at time of consents. The study's time frame inclusive will be from 2013 till 2016.

Studietype

Intervensjonell

Registrering (Faktiske)

177

Fase

  • Ikke aktuelt

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 til 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Gravid women greater than 37 weeks undergoing elective cesarean delivery.

Exclusion Criteria:

  • Intra-operative bowel surgery
  • Preeclampsia requiring magnesium sulfate
  • Diabetes Mellitus.
  • Planned secondary closure of the skin incision
  • Any gastrointestinal and/or medical conditions that precludes early consumption of solid food
  • General anesthesia
  • Gestational age less than 37 weeks.
  • Patients who are mentally incapacitated or decisionally impaired.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Early Feeding Arm
Patients will be started on regular diet within 6 hrs postoperative.
Annen: Regular diet within 6hrs postoperative
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
Ingen inngripen: Late Feeding Group
Patients will be remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs as standard postoperative protocol in the investigators' institution.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Passing Flatus
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
The primary outcome is the duration in minutes from surgery completion(skin closure) and time of passage of first flatus (passing gas per anus).
participants will be followed for the duration of hospital stay, an expected average of 2-5 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bowel sounds
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
First time in minutes from completion of surgery that bowel sounds are heard active.
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Bowel Evacuation
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
First time in minutes from completion of surgery that patient reports passing bowel movement or stools.
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Nausea or vomiting
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
First time in minutes from completion of surgery that patient reports nauseated or has actually had emesis.
participants will be followed for the duration of hospital stay, an expected average of 2-5 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Texas Medical Branch, Galveston

Etterforskere

  • Hovedetterforsker: Antonio F Saad, MD, UTMB Galveston Texas

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. mars 2014

Primær fullføring (Faktiske)

1. juli 2014

Studiet fullført (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først innsendt

26. februar 2015

Først innsendt som oppfylte QC-kriteriene

18. mars 2015

Først lagt ut (Anslag)

24. mars 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. mars 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mars 2015

Sist bekreftet

1. mars 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 13-0391

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