Early Feeding After A Cesarean Delivery Hastens Recovery Time for Bowel Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section

NCT03680391

Post Operative Recovery

UNKNOWN

Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

NCT02332278

Complications; Cesarean Section

COMPLETED NA

Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital

NCT03070795

Cesarean Section Complications

UNKNOWN NA

Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section

NCT06539117

Complication Postoperative

COMPLETED NA

Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

NCT06316024

Cesarean Section

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Disorders, Functional

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Feeding Arm

Patients will be started on regular diet within 6 hrs postoperative.

Group Type EXPERIMENTAL

Regular diet within 6hrs postoperative

Intervention Type OTHER

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.

Late Feeding Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Regular diet within 6hrs postoperative

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No