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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349151
• Other study ID #: ATADEK-2017/4
• Status: Completed
• Phase: N/A
• Start date: November 19, 2017
• Est. completion date: March 10, 2018

Study information

• Verified date: August 2019
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: March 10, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Early feeding
Feeding on postoperative 2nd hour on return to the ward
• On- Demand feeding
Feeding whenever the patient asks for on return to the ward

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul	Sariyer

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View 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. — View Citation

Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after caesarean section. Cochrane Database Syst Rev. 2002;(3):CD003516. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 day 0 to day 2.
Secondary	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.	Thirty minutes after the surgery
Secondary	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.	Postoperative from day 0 to day 2