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

Not Applicable

Completed

• Conditions: Cesarean Delivery; Postoperative Nausea and Vomiting; Patient Satisfaction; Feeding Patterns
• Interventions: Behavioral: Early feeding; Behavioral: On- Demand feeding

• Registration Number: NCT03349151
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-18
• Study Start: 2017-11-19
• Study First Posted: 2017-11-21
• Primary Completion: 2018-03-10
• Study Completion: 2018-03-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 262

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early feeding	Early feeding	This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.
On- demand feeding	On- Demand feeding	This group will be served soft meal diet served whenever they wanted to eat on return to the ward.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Acibadem Maslak Hospital; 🇹🇷 Istanbul, Sariyer, Turkey