Prevent Postopertive Nausea and VomitingNCT05233280
Early Versus Delayed Oral Liquids and Soft Food After Elective Ceasarean Section
An observational study of Prevent Postopertive Nausea and Vomiting, run by Ain Shams University.
Trial summary
To compare the safety of early versus delayed oral feeding after uncomplicated cesarean section under spinal anesthesia Read more about this study
- Who is it for?
- Ages 17 to 50 years, women only
- Conditions the study is for
- Prevent Postopertive Nausea and Vomiting
- What is being tested?
- Oral liquids and soft food 2 hours postoperative
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to 15 Apr 2022
- Phase
- Observational
- 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 17 to 50 years
- Women only
- Child, Adult
Study population: Women in child bearing period
Who may be able to join
- previous 1,2,3 cs Uncomplicated elective cs Singletone pregnancy Spinal anesthesia
Who cannot join
- women with medical disorder HTN, DM History of bowel surgery or intraoprative complication Contraindication to spinal anesthesia
Trial locations and contacts
No sites are listed yet.
Magdy Kolib contact
About this study
To compare the safety of early versus delayed oral feeding after uncomplicated cesarean section under spinal anesthesia
Read the detailed description
Cesarean section is one of most common surgical procedures saving both for mother and newborn when medically indicated .traditionally patients are not given fluids or food afer abdominal surgery until bowel function return as evidenced by bowel sounds passage of flatus or stool or feeling of hunger the rationale of this practice is to prevent postoperative nausea , vomiting, distension and other complications
- Conditions
- Prevent Postopertive Nausea and Vomiting
- Being tested
- Oral liquids and soft food 2 hours postoperative
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral liquids and soft food 2 hours postoperativeOther
Early versus delayed oral liquid feeding after ceasarean section
| Study group | Role | What they receive |
|---|---|---|
| Group A | Early feeding group Receives: Other: Oral liquids and soft food 2 hours postoperative | |
| Group B | Delayed feeding group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of passage of flatus
Measured: 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevent Postopertive Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233280
- Sponsor's protocol ID
- Oral feeding after ceasarean
- Status last verified
- Dec 2021
- First submitted
- 1 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Oral Liquids and Soft Food After Elective Ceasarean Section
- ClinicalTrials.gov ID
- NCT05233280
- Acronym / sponsor ID
- Oral feeding after ceasarean
- Conditions
- Prevent Postopertive Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 10 Feb 2022 (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 the safety of early versus delayed oral feeding after uncomplicated cesarean section under spinal anesthesia
Detailed description
Cesarean section is one of most common surgical procedures saving both for mother and newborn when medically indicated .traditionally patients are not given fluids or food afer abdominal surgery until bowel function return as evidenced by bowel sounds passage of flatus or stool or feeling of hunger the rationale of this practice is to prevent postoperative nausea , vomiting, distension and other complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Oral liquids and soft food 2 hours postoperativeEarly feeding group |
| Group B | – | –Delayed feeding group |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Women in child bearing period
Key inclusion criteria (1 listed)
- previous 1,2,3 cs Uncomplicated elective cs Singletone pregnancy Spinal anesthesia
Key exclusion criteria (1 listed)
- women with medical disorder HTN, DM History of bowel surgery or intraoprative complication Contraindication to spinal anesthesia
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 |
|---|---|---|
| Oral liquids and soft food 2 hours postoperativeEarly versus delayed oral liquid feeding after ceasarean section | Other | Group A |
Primary outcome
Time of passage of flatus
Time frame: 6 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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.
Magdy Kolib contact
Questions about this trial
What is this clinical trial studying?
An observational study of Prevent Postopertive Nausea and Vomiting, run by Ain Shams University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousra Abdelsattar (01001115045, Yosraabdelsatar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of passage of flatus (time frame: 6 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.