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

NCT ID: NCT03349151

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-19

Study Completion Date

2018-03-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Cesarean Delivery Feeding Patterns Patient Satisfaction Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early feeding

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

Group Type ACTIVE_COMPARATOR

Early feeding

Intervention Type BEHAVIORAL

Feeding on postoperative 2nd hour on return to the ward

On- demand feeding

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

Group Type PLACEBO_COMPARATOR

On- Demand feeding

Intervention Type BEHAVIORAL

Feeding whenever the patient asks for on return to the ward

Interventions

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Early feeding

Feeding on postoperative 2nd hour on return to the ward

Intervention Type BEHAVIORAL

On- Demand feeding

Feeding whenever the patient asks for on return to the ward

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Esra Ozbasli

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mete Gungor, MD, Prof.

Role: STUDY_DIRECTOR

Acibadem MAA University

Locations

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Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12431715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12137699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24856433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25794417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8684757 (View on PubMed)

Other Identifiers

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ATADEK-2017/4

Identifier Type: -

Identifier Source: org_study_id

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