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

Sponsor
Acibadem University (Other)
Overall Status
Completed
CT.gov ID
NCT03349151
Collaborator
(none)
262
1
2
3.6
71.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Early feeding
  • Behavioral: On- Demand feeding
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
262 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomisedProspective randomised
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery
Actual Study Start Date :
Nov 19, 2017
Actual Primary Completion Date :
Mar 10, 2018
Actual Study Completion Date :
Mar 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction [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.

Secondary Outcome Measures

  1. Postoperative passage of flatus and defecation [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.

  2. Postoperative gastrointestinal complaints [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.

  3. Postoperative pain medication [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acibadem Maslak Hospital Istanbul Sariyer Turkey 34457

Sponsors and Collaborators

  • Acibadem University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Esra Ozbasli, Instructor, Acibadem University
ClinicalTrials.gov Identifier:
NCT03349151
Other Study ID Numbers:
  • ATADEK-2017/4
First Posted:
Nov 21, 2017
Last Update Posted:
Aug 13, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esra Ozbasli, Instructor, Acibadem University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2019