Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery

August 9, 2019 updated by: Esra Ozbasli, Acibadem University
To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two hundred uncomplicated singleton term pregnancies who had caesarean section under regional anaesthesia will be included in our trial. Patients will be randomized to a soft food diet (honey, skimmed cheese, soup, mashed potatoe, pudding, grissini) served on postoperative 2nd hour or whenever they wanted to eat on return to the ward. Thirty minutes after they eat their meal, nausea, vomiting, ileus and distention will be questioned. Participants will be provided with the visual analogue scale (VAS), which will be presented with a statement explaining what was intended to measure. Patient satisfaction before discharge from hospital will be recorded by the patient by using a 100-mm VAS (0= minimum satisfaction, 100= maximum satisfaction). Time to first flatus passage and defecation will be recorded after the caesarean section.

Study Type

Interventional

Enrollment (Actual)

262

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

  • Turkey
    • Sariyer
      • Istanbul, Sariyer, Turkey, 34457
        • Acibadem Maslak Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Uncomplicated singleton term pregnancy
  • Planned or intrapartum uncomplicated cesarean section
  • Cesarean section under regional anesthesia

Exclusion Criteria:

  • General anesthesia
  • History of bowel surgery
  • Prenatal diagnosis of fetal anomaly
  • Maternal disease
  • Intraoperative or immediate postoperative major complications

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Early feeding
This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.
Behavioral: Early feeding
Feeding on postoperative 2nd hour on return to the ward
PLACEBO_COMPARATOR: On- demand feeding
This group will be served soft meal diet served whenever they wanted to eat on return to the ward.
Behavioral: On- Demand feeding
Feeding whenever the patient asks for on return to the ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: On postoperative day 2 before they are discharged from the hospital.
The primary outcome is patient satisfaction before discharge from hospital, measured using a scale called visual analogue scale (VAS). It is a 100-mm long scale with adjectival descriptions at both end positions. There will be a statement explaining what was intended to measure. Participants will be asked to mark the VAS on the second they of the surgery before they are discharged from the hospital. On this scale 0= lack of satisfaction from the timing of having their meal after the surgery 100= full satisfaction from the timing of their meal after the surgery.
On postoperative day 2 before they are discharged from the hospital.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative passage of flatus and defecation
Time Frame: Postoperative day 0 to day 2.
The participants will be asked to inform the nurse when they have their first passage of flatus and defecation.
Postoperative day 0 to day 2.
Postoperative gastrointestinal complaints
Time Frame: Thirty minutes after the surgery
Thirty minutes after the surgery the nurse will question the patients if they have a complaint of nausea, vomiting or abdominal distention.
Thirty minutes after the surgery
Postoperative pain medication
Time Frame: Postoperative from day 0 to day 2
After the surgery the need for pain medication will be followed. The name of the medicine, the time when the pain killer was used, the dosage of the medicine will be recorded.
Postoperative from day 0 to day 2

Collaborators and Investigators

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

Sponsor

Acibadem University

Investigators

  • Study Director: Mete Gungor, MD, Prof., Acibadem MAA University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

November 19, 2017

Primary Completion (ACTUAL)

March 10, 2018

Study Completion (ACTUAL)

March 10, 2018

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 18, 2017

First Posted (ACTUAL)

November 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2017/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, statistical analysis plan might be shared when the study is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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