Cesarean DeliveryNCT03349151
Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery
A study testing Early feeding and On- Demand feeding in people with Cesarean Delivery and Feeding Patterns, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery, Feeding Patterns, Patient Satisfaction
- What is being tested?
- Early feeding and On- Demand feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2017to 10 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated singleton term pregnancy
- Planned or intrapartum uncomplicated cesarean section
- Cesarean section under regional anesthesia
Who cannot join
- General anesthesia
- History of bowel surgery
- Prenatal diagnosis of fetal anomaly
- Maternal disease
- Intraoperative or immediate postoperative major complications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Maslak Hospital
Istanbul, Sariyer, 34457
About this study
To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.
Read the 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.
- Conditions
- Cesarean Delivery, Feeding Patterns, Patient Satisfaction, Postoperative Nausea and Vomiting
- Being tested
- Early feeding, On- Demand feeding
- Keywords
- Postoperative maternal feeding, cesarean section
- Medical subject headings
- Feeding Behavior, Patient Satisfaction, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feedingBehavioural
Feeding on postoperative 2nd hour on return to the ward
On- Demand feedingBehavioural
Feeding whenever the patient asks for on return to the ward
| Study group | Role | What they receive |
|---|---|---|
| Early feeding | Active comparator | This group will be served soft meal diet served on postoperative 2nd hour on return to the ward. Receives: Behavioral: Early feeding |
| On- demand feeding | Placebo comparator | This group will be served soft meal diet served whenever they wanted to eat on return to the ward. Receives: Behavioral: On- Demand feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On postoperative day 2 before they are discharged from the hospital.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Postoperative from day 0 to day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start19 Nov 2017
- Primary completion10 Mar 2018
- Study completion10 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ozbasli, Acibadem University
- Investigators
- Mete Gungor, MD, Prof., Study director, Acibadem MAA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349151
- Sponsor's protocol ID
- ATADEK-2017/4
- Status last verified
- Aug 2019
- First submitted
- 14 Nov 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, statistical analysis plan might be shared when the study is completed.
Publications
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.
PubMed 12431715Mangesi 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.
PubMed 12137699Masood 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.
PubMed 24856433Wrench 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.
PubMed 25794417Kramer 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.
PubMed 8684757
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03349151
- Acronym / sponsor ID
- ATADEK-2017/4
- Conditions
- Cesarean Delivery, Feeding Patterns, Patient Satisfaction, Postoperative Nausea and Vomiting
- Keywords
- Postoperative maternal feeding, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 19 Nov 2017 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomised
| Arm | Type | Receives |
|---|---|---|
| Early feeding | Active comparator | Behavioral: Early feedingThis group will be served soft meal diet served on postoperative 2nd hour on return to the ward. |
| On- demand feeding | Placebo comparator | Behavioral: On- Demand feedingThis group will be served soft meal diet served whenever they wanted to eat on return to the ward. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Uncomplicated singleton term pregnancy
- Planned or intrapartum uncomplicated cesarean section
- Cesarean section under regional anesthesia
Key exclusion criteria (5 listed)
- General anesthesia
- History of bowel surgery
- Prenatal diagnosis of fetal anomaly
- Maternal disease
- Intraoperative or immediate postoperative major complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early feedingFeeding on postoperative 2nd hour on return to the ward | Behavioural | Early feeding |
| On- Demand feedingFeeding whenever the patient asks for on return to the ward | Behavioural | On- demand feeding |
Primary outcome
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.
3 secondary outcomes
Postoperative passage of flatus and defecation
Time frame: Postoperative day 0 to day 2.
Postoperative gastrointestinal complaints
Time frame: Thirty minutes after the surgery
Postoperative pain medication
Time frame: Postoperative from day 0 to day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 12431715Bisgaard 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.
- Background: PubMed 12137699Mangesi 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.
- Background: PubMed 24856433Masood 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.
- Background: PubMed 25794417Wrench 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.
- Background: PubMed 8684757Kramer 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.
- Individual participant dataSharing planned: No. Study protocol, statistical analysis plan might be shared when the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mete Gungor, MD, Prof. study director
Acibadem MAA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early feeding and On- Demand feeding in people with Cesarean Delivery and Feeding Patterns, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: On postoperative day 2 before they are discharged from the hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03349151, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.