Clinical trial NCT03349151: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery
Feeding Patterns
Patient Satisfaction
Postoperative Nausea and Vomiting
Keywords: Postoperative maternal feeding, cesarean section
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 262
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient satisfaction
timeFrame: On postoperative day 2 before they are discharged from the hospital.
Secondary outcomes:
measure: Postoperative passage of flatus and defecation
timeFrame: Postoperative day 0 to day 2.
measure: Postoperative gastrointestinal complaints
timeFrame: Thirty minutes after the surgery
measure: Postoperative pain medication
timeFrame: Postoperative from day 0 to day 2
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
affiliation: Acibadem MAA University
name: Mete Gungor, MD, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.