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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Disorders, Functional
• Intervention / Treatment: Other: Regular diet within 6hrs postoperative

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Feeding Arm; Patients will be started on regular diet within 6 hrs postoperative.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel sounds	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	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	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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Antonio F Saad, MD, UTMB Galveston Texas

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 13-0391