Gastrointestinal Disorders, Functional Clinical Trial
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.
| Status | Completed |
| Enrollment | 177 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Gravid women greater than 37 weeks undergoing elective cesarean delivery. Exclusion Criteria: - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Medical Branch, Galveston |
Bar 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. — View Citation
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):1327-34. doi: 10.1097/AOG.0b013e318293698c. Review. — View Citation
Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | participants will be followed for the duration of hospital stay, an expected average of 2-5 days | No |
| Secondary | Bowel sounds | First time in minutes from completion of surgery that bowel sounds are heard active. | participants will be followed for the duration of hospital stay, an expected average of 2-5 days | No |
| Secondary | Bowel Evacuation | First time in minutes from completion of surgery that patient reports passing bowel movement or stools. | participants will be followed for the duration of hospital stay, an expected average of 2-5 days | No |
| Secondary | Nausea or vomiting | First time in minutes from completion of surgery that patient reports nauseated or has actually had emesis. | participants will be followed for the duration of hospital stay, an expected average of 2-5 days | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02327377 -
Web-based Management of Pediatric Functional Abdominal Pain
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N/A |