Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

January 4, 2015 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.

To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

444

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas H

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cesarean section with regional anesthesia, regardless of gestational age.

Exclusion Criteria:

  • Use of magnesium sulphate
  • General anesthesia
  • Pre gestational or gestational diabetes
  • Bowel injury during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early feeding
Early feeding (fluid diet), four hours after cesarean section.
Procedure: Early feeding
Fluid diet four hours after cesarean section
Active Comparator: Late feeding
Late feeding (fluid diet) 12 hours after cesarean section.
Procedure: Late feeding
Fluid diet 12 hours after cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adynamic ileus
Time Frame: 72 hours
Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 72 hours
Level of pain, using a visual scale (12, 24, 48 and 72 hours after surgery)
72 hours
Satisfaction
Time Frame: 72 hours
Personal satisfaction, using a numeric scale (12, 24, 48 and 72 hours after surgery)
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Investigators

  • Principal Investigator: Ana Lia Becerra, MD, Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 4, 2015

First Submitted That Met QC Criteria

January 4, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MHST2014-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complications; Cesarean Section

Clinical Trials on Early feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe