Post Operative RecoveryNCT03680391
Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section
An observational study of Post Operative Recovery, run by Cairo University at 1 site in Egypt.
Trial summary
Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Operative Recovery
- What is being tested?
- Cesarean section
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Oct 2019
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital. 1. all Women included in the study have undergo history taking and general examination 2. All patient in the study are randomized in two groups: Group A: 103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage Group B: 97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique: * spinal anethesia * pfennenstiel imcision * lower segment cesarean section * suturing uterus in two layers while exterionezed * gentle manibulation * no towels in gutters will be used
Who may be able to join
- Maternal age from 20 to 40
- Primigravida and previous one or two cesarean section
- Elective cesarean section
- regional anesthesia .singleton pregnancy.
Who cannot join
- age below 20 years old or above 40 years old
- medical disorders as (hypertension, diabetes , liver or kidney diseases)
- complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
- general anesthesia
- multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Mohamed Shalaby, MD contact
About this study
Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital
Read the detailed description
- Study Methods
Population of study \& disease condition :
Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital.
Inclusion criteria:
- Maternal age from 20 to 40
- Primigravida and previous one or two cesarean section
- Elective cesarean section
- regional anesthesia .singleton pregnancy.
Exclusion criteria:
- age below 20 years old or above 40 years old
- medical disorders as (hypertension, diabetes , liver or kidney diseases)
- complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
- general anesthesia
- multiple pregnancy
Methodology in details:
- all Women included in the study have undergo history taking and general examination
- All patient in the study are randomized in two groups:
Group A:
103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage
Group B:
97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique:
- spinal anethesia
- pfennenstiel imcision
- lower segment cesarean section
- suturing uterus in two layers while exterionezed
- gentle manibulation
- no towels in gutters will be used 4_ comparison will be held between both groups according:
- postoperative intestinal sounds.
- postoperative nausea and vomiting
- postoprative abdominal distension
- postoperative pain
- postoperative ambulation
- postoperative ileus
- postoperative discharge time from hospital
- Conditions
- Post Operative Recovery
- Being tested
- Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean sectionProcedure or surgery
Both groups cesarean section will be held with the same technique:
- spinal anethesia
- pfennenstiel imcision
- lower segment cesarean section
- suturing uterus in two layers while exterionezed
- gentle manibulation
- no towels in gutters will be used
| Study group | Role | What they receive |
|---|---|---|
| early postoperative feeding | 103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage Receives: Procedure: Cesarean section | |
| Late postoperative feeding | 97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool Receives: Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction before discharge from hospital
satisfaction score from 1 to 10 where 1 is totally non satisfied and 10 fully satisfied
Measured: 2 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative RecoveryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680391
- Sponsor's protocol ID
- 41
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section
- ClinicalTrials.gov ID
- NCT03680391
- Acronym / sponsor ID
- 41
- Conditions
- Post Operative Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 21 Sep 2018 (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.
Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital
Detailed description
- Study Methods
Population of study \& disease condition :
Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital.
Inclusion criteria:
- Maternal age from 20 to 40
- Primigravida and previous one or two cesarean section
- Elective cesarean section
- regional anesthesia .singleton pregnancy.
Exclusion criteria:
- age below 20 years old or above 40 years old
- medical disorders as (hypertension, diabetes , liver or kidney diseases)
- complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
- general anesthesia
- multiple pregnancy
Methodology in details:
- all Women included in the study have undergo history taking and general examination
- All patient in the study are randomized in two groups:
Group A:
103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage
Group B:
97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique:
- spinal anethesia
- pfennenstiel imcision
- lower segment cesarean section
- suturing uterus in two layers while exterionezed
- gentle manibulation
- no towels in gutters will be used 4_ comparison will be held between both groups according:
- postoperative intestinal sounds.
- postoperative nausea and vomiting
- postoprative abdominal distension
- postoperative pain
- postoperative ambulation
- postoperative ileus
- postoperative discharge time from hospital
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early postoperative feeding | – | Procedure: Cesarean section103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage |
| Late postoperative feeding | – | Procedure: Cesarean section97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital. 1. all Women included in the study have undergo history taking and general examination 2. All patient in the study are randomized in two groups: Group A: 103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage Group B: 97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique: * spinal anethesia * pfennenstiel imcision * lower segment cesarean section * suturing uterus in two layers while exterionezed * gentle manibulation * no towels in gutters will be used
Key inclusion criteria (4 listed)
- Maternal age from 20 to 40
Key exclusion criteria (5 listed)
- age below 20 years old or above 40 years old
- medical disorders as (hypertension, diabetes , liver or kidney diseases)
- complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
- general anesthesia
- multiple pregnancy
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 |
|---|---|---|
| Cesarean sectionBoth groups cesarean section will be held with the same technique: * spinal anethesia * pfennenstiel imcision * lower segment cesarean section * suturing uterus in two layers while exterionezed * gentle manibulation * no towels in gutters will be used | Procedure or surgery | Late postoperative feeding, early postoperative feeding |
Primary outcome
Patient satisfaction before discharge from hospital
Time frame: 2 days after the operation
satisfaction score from 1 to 10 where 1 is totally non satisfied and 10 fully satisfied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Shalaby, MD contact
Ahmed maged, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Recovery, run by Cairo University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2018. 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 Egypt. 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. 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 Ahmed maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction before discharge from hospital (time frame: 2 days after the operation). 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 21 Sep 2018.