NCT02396485|CompletedDMC
Early Feeding After A Cesarean Delivery Hastens Recovery Time for Bowel Function
Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial
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Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial
Sponsor study identifier
interventional
177
0 countries
N/A
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 2014
Actual (reported)July 2014
Actual (reported)February 26, 2015
Actual (reported)March 24, 2015
Actual (reported)Passing Flatus
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
Bowel sounds
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Bowel Evacuation
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Nausea or vomiting
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Patients will be started on regular diet within 6 hrs postoperative.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hsu YY, Hung HY, Chang SC, Chang YJ. Early oral intake and gastrointestinal function after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2013 Jun;121(6):1327-1334. doi: 10.1097/AOG.0b013e318293698c.
Bar G, Sheiner E, Lezerovizt A, Lazer T, Hallak M. Early maternal feeding following caesarean delivery: a prospective randomised study. Acta Obstet Gynecol Scand. 2008;87(1):68-71. doi: 10.1080/00016340701778849.
Antonio F Saad, MD
UTMB Galveston Texas
177 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2015
First Posted
March 24, 2015
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
PHAGE Study: Bacteriophages as Novel Prebiotics
Contact the study team to confirm eligibility.
Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. doi: 10.1016/s0029-7844(01)01387-4.
Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
March 24, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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