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

Study Overview
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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.

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

Conditions
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Cesarean Delivery, Feeding Patterns, Patient Satisfaction, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Behavioral: Early feeding
* Behavioral: On- Demand feeding


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early feeding<br>This group will be served soft meal diet served on postoperative 2nd hour on return to the ward. | Behavioral: Early feeding<br>* Feeding on postoperative 2nd hour on return to the ward<br>|
| Placebo Comparator: On- demand feeding<br>This group will be served soft meal diet served whenever they wanted to eat on return to the ward. | Behavioral: On- Demand feeding<br>* Feeding whenever the patient asks for on return to the ward<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative maternal feeding, cesarean section