An interventional study of Early feeding and On- Demand feeding in Cesarean Delivery, Feeding Patterns and Patient Satisfaction, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Acibadem University · Not applicable, Interventional, and Supportive care
To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's enrollment of 262 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.
Behavioral: Early feeding
This group will be served soft meal diet served whenever they wanted to eat on return to the ward.
Behavioral: On- Demand feeding
Feeding on postoperative 2nd hour on return to the ward
Feeding whenever the patient asks for on return to the ward
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.
Time frame: On postoperative day 2 before they are discharged from the hospital.
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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative from day 0 to day 2
Plan to share: No — Study protocol, statistical analysis plan might be shared when the study is completed.
Ran from Nov 2017 to primary completion in Mar 2018, 3 months.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 3 months is below that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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