Gastrointestinal Disorders, FunctionalNCT02396485
Early Feeding After A Cesarean Delivery Hastens Recovery Time for Bowel Function
A study testing Regular diet within 6hrs postoperative in people with Gastrointestinal Disorders, Functional, run by The University of Texas Medical Branch, Galveston.
Trial summary
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached for participation in the study. The study informed consent will be obtained. The study's time frame inclusive will be from 2013 till 2016. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gastrointestinal Disorders, Functional
- What is being tested?
- Regular diet within 6hrs postoperative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jul 2014
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gravid women greater than 37 weeks undergoing elective cesarean delivery.
Who cannot join
- Intra-operative bowel surgery
- Preeclampsia requiring magnesium sulfate
- Diabetes Mellitus.
- Planned secondary closure of the skin incision
- Any gastrointestinal and/or medical conditions that precludes early consumption of solid food
- General anesthesia
- Gestational age less than 37 weeks.
- Patients who are mentally incapacitated or decisionally impaired.
About this study
Official title: Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached for participation in the study. The study informed consent will be obtained. The study's time frame inclusive will be from 2013 till 2016.
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be performed using a computer generated random list of numbers assigning patients to the 2 groups of the study. This list of random number assignments will be kept secure in an opaque envelope until the end of the study. Patients in the Early group will be started on regular diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO 12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as tolerated, i.e. if clears were tolerated or flatus or bowel movement occurred, patients will be started on solid foods. If diet not tolerated, a full liquid diet will be given instead. Consequently if patient tolerated full liquid diet, a regular diet will be then initiated. Patients will be discharged home only if they tolerate solid food with absence of emesis, have flatus or bowel movement. Time Zero is defined as time of skin incision.
Read the detailed description
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached by Principal investigator or any of the co-investigators for participation in the study during the the preoperative visit which coincides with the same day of scheduled cesarean in a private patient room. . Prospective subjects will be presenting for their preoperative appointment (same day of scheduled cesarean delivery) in labor and delivery and will be asked to participate in the study. The study will be explained as in the consent form and if agreed patients will elect either to or not to participate in the study after all risks and benefits are explained. Data to be collected will consist of time in minutes of passing flatus, time in minutes of having a bowel movement, hospital length of stay, postoperative nausea, vomiting and presence of ileus (unable to tolerate diet, abdominal distention, no bowel movement nor flatus, abdominal x-ray demonstrating air/fluid levels in bowel). Patients will be contacted once to twice a day for assessment of data points mentioned above. If elected to participate consents will be obtained. Randomization will be done at time of consents. The study's time frame inclusive will be from 2013 till 2016.
- Conditions
- Gastrointestinal Disorders, Functional
- Being tested
- Regular diet within 6hrs postoperative
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular diet within 6hrs postoperativeOther
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
| Study group | Role | What they receive |
|---|---|---|
| Early Feeding Arm | Experimental | Patients will be started on regular diet within 6 hrs postoperative. Receives: Other: Regular diet within 6hrs postoperative |
| Late Feeding Group | No intervention | Patients will be remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs as standard postoperative protocol in the investigators' institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passing Flatus
The primary outcome is the duration in minutes from surgery completion(skin closure) and time of passage of first flatus (passing gas per anus).
Measured: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Secondary outcomes (3)
Bowel sounds
First time in minutes from completion of surgery that bowel sounds are heard active.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Bowel Evacuation
First time in minutes from completion of surgery that patient reports passing bowel movement or stools.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Nausea or vomiting
First time in minutes from completion of surgery that patient reports nauseated or has actually had emesis.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Disorders, FunctionalStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio F Saad, MD, Principal investigator, UTMB Galveston Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396485
- Sponsor's protocol ID
- 13-0391
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu YY, Hung HY, Chang SC, Chang YJ. Early oral intake and gastrointestinal function after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2013 Jun;121(6):1327-1334. doi: 10.1097/AOG.0b013e318293698c.
PubMed 23812470Bar G, Sheiner E, Lezerovizt A, Lazer T, Hallak M. Early maternal feeding following caesarean delivery: a prospective randomised study. Acta Obstet Gynecol Scand. 2008;87(1):68-71. doi: 10.1080/00016340701778849.
PubMed 18158630Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. doi: 10.1016/s0029-7844(01)01387-4.
PubMed 11430967Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19.
PubMed 26479169
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02396485
- Acronym / sponsor ID
- 13-0391
- Conditions
- Gastrointestinal Disorders, Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Mar 2015 (estimated)
- 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.
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached for participation in the study. The study informed consent will be obtained. The study's time frame inclusive will be from 2013 till 2016.
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be performed using a computer generated random list of numbers assigning patients to the 2 groups of the study. This list of random number assignments will be kept secure in an opaque envelope until the end of the study. Patients in the Early group will be started on regular diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO 12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as tolerated, i.e. if clears were tolerated or flatus or bowel movement occurred, patients will be started on solid foods. If diet not tolerated, a full liquid diet will be given instead. Consequently if patient tolerated full liquid diet, a regular diet will be then initiated. Patients will be discharged home only if they tolerate solid food with absence of emesis, have flatus or bowel movement. Time Zero is defined as time of skin incision.
Detailed description
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached by Principal investigator or any of the co-investigators for participation in the study during the the preoperative visit which coincides with the same day of scheduled cesarean in a private patient room. . Prospective subjects will be presenting for their preoperative appointment (same day of scheduled cesarean delivery) in labor and delivery and will be asked to participate in the study. The study will be explained as in the consent form and if agreed patients will elect either to or not to participate in the study after all risks and benefits are explained. Data to be collected will consist of time in minutes of passing flatus, time in minutes of having a bowel movement, hospital length of stay, postoperative nausea, vomiting and presence of ileus (unable to tolerate diet, abdominal distention, no bowel movement nor flatus, abdominal x-ray demonstrating air/fluid levels in bowel). Patients will be contacted once to twice a day for assessment of data points mentioned above. If elected to participate consents will be obtained. Randomization will be done at time of consents. The study's time frame inclusive will be from 2013 till 2016.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Feeding Arm | Experimental | Other: Regular diet within 6hrs postoperativePatients will be started on regular diet within 6 hrs postoperative. |
| Late Feeding Group | No intervention | –Patients will be remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs as standard postoperative protocol in the investigators' institution. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gravid women greater than 37 weeks undergoing elective cesarean delivery.
Key exclusion criteria (8 listed)
- Intra-operative bowel surgery
- Preeclampsia requiring magnesium sulfate
- Diabetes Mellitus.
- Planned secondary closure of the skin incision
- Any gastrointestinal and/or medical conditions that precludes early consumption of solid food
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 |
|---|---|---|
| Regular diet within 6hrs postoperativePatients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution. | Other | Early Feeding Arm |
Primary outcome
Passing Flatus
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
The primary outcome is the duration in minutes from surgery completion(skin closure) and time of passage of first flatus (passing gas per anus).
3 secondary outcomes
Bowel sounds
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Bowel Evacuation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
Nausea or vomiting
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
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 24 Mar 2015.
- Background: PubMed 23812470Hsu YY, Hung HY, Chang SC, Chang YJ. Early oral intake and gastrointestinal function after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2013 Jun;121(6):1327-1334. doi: 10.1097/AOG.0b013e318293698c.
- Background: PubMed 18158630Bar G, Sheiner E, Lezerovizt A, Lazer T, Hallak M. Early maternal feeding following caesarean delivery: a prospective randomised study. Acta Obstet Gynecol Scand. 2008;87(1):68-71. doi: 10.1080/00016340701778849.
- Background: PubMed 11430967Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. doi: 10.1016/s0029-7844(01)01387-4.
- Derived from this study: PubMed 26479169Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19.
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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.
Antonio F Saad, MD principal investigator
UTMB Galveston Texas
Questions about this trial
What is this clinical trial studying?
A study testing Regular diet within 6hrs postoperative in people with Gastrointestinal Disorders, Functional, run by The University of Texas Medical Branch, Galveston.
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 8 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 24 Mar 2015. 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?
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?
Passing Flatus (time frame: participants will be followed for the duration of hospital stay, an expected average of 2-5 days). 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 NCT02396485, which also lists 4 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 24 Mar 2015.