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Completed

NCT Number: NCT03349151

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

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

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Key information

Conditions

Cesarean Delivery Behavior Behavior, Animal Feeding Behavior Feeding Patterns Health Behavior Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Treatment Adherence and Compliance Vomiting

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early feeding

Behavioral

Feeding on postoperative 2nd hour on return to the ward

On- Demand feeding

Behavioral

Feeding whenever the patient asks for on return to the ward

Primary outcomes

  1. Patient satisfaction

    Time frame: 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 outcomes

  1. Postoperative passage of flatus and defecation

    Time frame: 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.

  2. Postoperative gastrointestinal complaints

    Time frame: 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.

  3. Postoperative pain medication

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2017
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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