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

NCT02396485 | Completed DMC

• 1 other identifier: 13-0391
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastrointestinal Disorders, Functional

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Early Feeding Arm

EXPERIMENTAL

Patients will be started on regular diet within 6 hrs postoperative.

Other: Regular diet within 6hrs postoperative

Late Feeding Group

NO INTERVENTION

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.

Interventions

Regular diet within 6hrs postoperative OTHER

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.

Early Feeding Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Related Publications (4)

• 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.

  PMID: 23812470 BACKGROUND

• 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.

  PMID: 18158630 BACKGROUND

• 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.

  PMID: 11430967 BACKGROUND

• 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.

  PMID: 26479169 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Antonio F Saad, MD

  UTMB Galveston Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03