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

18 mars 2015 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

177

Fas

  • Inte tillämpbar

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 till 55 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Early Feeding Arm
Patients will be started on regular diet within 6 hrs postoperative.
Övrig: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Passing Flatus
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bowel sounds
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Texas Medical Branch, Galveston

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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

1 mars 2014

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

26 februari 2015

Först inskickad som uppfyllde QC-kriterierna

18 mars 2015

Första postat (Uppskatta)

24 mars 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 mars 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 mars 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 13-0391

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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