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

NCT03349151 | Completed

• 1 other identifier: ATADEK-2017/4
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Delivery; Feeding Patterns; Patient Satisfaction; Postoperative Nausea and Vomiting

Keywords

Postoperative maternal feeding, cesarean section

Outcome Measures

Primary Outcomes (1)

• 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.

  On postoperative day 2 before they are discharged from the hospital.

Secondary Outcomes (3)

• Postoperative passage of flatus and defecation

  Postoperative day 0 to day 2.

• Postoperative gastrointestinal complaints

  Thirty minutes after the surgery

• Postoperative pain medication

  Postoperative from day 0 to day 2

Study Arms (2)

Early feeding

ACTIVE COMPARATOR

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

Behavioral: Early feeding

On- demand feeding

PLACEBO COMPARATOR

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

Behavioral: On- Demand feeding

Interventions

Early feeding BEHAVIORAL

Feeding on postoperative 2nd hour on return to the ward

Early feeding

On- Demand feeding BEHAVIORAL

Feeding whenever the patient asks for on return to the ward

On- demand feeding

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 12431715 BACKGROUND

• 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.

  PMID: 12137699 BACKGROUND

• 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.

  PMID: 24856433 BACKGROUND

• 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.

  PMID: 25794417 BACKGROUND

• 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.

  PMID: 8684757 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior; Patient Satisfaction; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Treatment Adherence and Compliance; Health Behavior; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Mete Gungor, MD, Prof.

  Acibadem MAA University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Prospective randomised

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 21, 2017
• Study Start: November 19, 2017
• Primary Completion: March 10, 2018
• Study Completion: March 10, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)