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

Primary Purpose

Cesarean Delivery, Feeding Patterns, Patient Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Early feeding
On- Demand feeding
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Delivery focused on measuring Postoperative maternal feeding, cesarean section

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Acibadem Maslak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Early feeding

On- demand feeding

Arm Description

This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.

This group will be served soft meal diet served whenever they wanted to eat on return to the ward.

Outcomes

Primary Outcome Measures

Patient satisfaction
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.

Secondary Outcome Measures

Postoperative passage of flatus and defecation
The participants will be asked to inform the nurse when they have their first passage of flatus and defecation.
Postoperative gastrointestinal complaints
Thirty minutes after the surgery the nurse will question the patients if they have a complaint of nausea, vomiting or abdominal distention.
Postoperative pain medication
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.

Full Information

First Posted
November 14, 2017
Last Updated
August 9, 2019
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT03349151
Brief Title
Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery
Official Title
Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 19, 2017 (Actual)
Primary Completion Date
March 10, 2018 (Actual)
Study Completion Date
March 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Delivery, Feeding Patterns, Patient Satisfaction, Postoperative Nausea and Vomiting
Keywords
Postoperative maternal feeding, cesarean section

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early feeding
Arm Type
Active Comparator
Arm Description
This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.
Arm Title
On- demand feeding
Arm Type
Placebo Comparator
Arm Description
This group will be served soft meal diet served whenever they wanted to eat on return to the ward.
Intervention Type
Behavioral
Intervention Name(s)
Early feeding
Intervention Description
Feeding on postoperative 2nd hour on return to the ward
Intervention Type
Behavioral
Intervention Name(s)
On- Demand feeding
Intervention Description
Feeding whenever the patient asks for on return to the ward
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
On postoperative day 2 before they are discharged from the hospital.
Secondary Outcome Measure Information:
Title
Postoperative passage of flatus and defecation
Description
The participants will be asked to inform the nurse when they have their first passage of flatus and defecation.
Time Frame
Postoperative day 0 to day 2.
Title
Postoperative gastrointestinal complaints
Description
Thirty minutes after the surgery the nurse will question the patients if they have a complaint of nausea, vomiting or abdominal distention.
Time Frame
Thirty minutes after the surgery
Title
Postoperative pain medication
Description
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.
Time Frame
Postoperative from day 0 to day 2

10. Eligibility

Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mete Gungor, MD, Prof.
Organizational Affiliation
Acibadem MAA University
Official's Role
Study Director
Facility Information:
Facility Name
Acibadem Maslak Hospital
City
Istanbul
State/Province
Sariyer
ZIP/Postal Code
34457
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol, statistical analysis plan might be shared when the study is completed.
Citations:
PubMed Identifier
12431715
Citation
Bisgaard T, Kehlet H. Early oral feeding after elective abdominal surgery--what are the issues? Nutrition. 2002 Nov-Dec;18(11-12):944-8. doi: 10.1016/s0899-9007(02)00990-5.
Results Reference
background
PubMed Identifier
12137699
Citation
Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after caesarean section. Cochrane Database Syst Rev. 2002;2002(3):CD003516. doi: 10.1002/14651858.CD003516.
Results Reference
background
PubMed Identifier
24856433
Citation
Masood SN, Masood Y, Naim U, Masood MF. A randomized comparative trial of early initiation of oral maternal feeding versus conventional oral feeding after cesarean delivery. Int J Gynaecol Obstet. 2014 Aug;126(2):115-9. doi: 10.1016/j.ijgo.2014.02.023. Epub 2014 Apr 29.
Results Reference
background
PubMed Identifier
25794417
Citation
Wrench IJ, Allison A, Galimberti A, Radley S, Wilson MJ. Introduction of enhanced recovery for elective caesarean section enabling next day discharge: a tertiary centre experience. Int J Obstet Anesth. 2015 May;24(2):124-30. doi: 10.1016/j.ijoa.2015.01.003. Epub 2015 Jan 14.
Results Reference
background
PubMed Identifier
8684757
Citation
Kramer RL, Van Someren JK, Qualls CR, Curet LB. Postoperative management of cesarean patients: the effect of immediate feeding on the incidence of ileus. Obstet Gynecol. 1996 Jul;88(1):29-32. doi: 10.1016/0029-7844(96)00131-7.
Results Reference
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Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery

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