Short Versus Standard Post-operative Stay After Elective Cesarean Delivery

July 4, 2018 updated by: Ahmed Mohamed Abbas, Assiut University
After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. There have been concerns that early postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia, anastomotic leakage, and wound dehiscence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women is sure of her last menstrual period or documented early pregnancy ultrasound.
  2. Women aged 20-35 years.
  3. Women with Body mass index18-22 kg/m2.
  4. Estimated gestational age is ranging between 37-40 weeks gestation.
  5. Accepting to participate in the study.

Exclusion Criteria:

  1. Smoker ≥ 11 cigarettes/day.
  2. Caesarean hysterectomy .
  3. Surgical management of severe postpartum haemorrhage .
  4. History of bowel obstruction , inflammatory bowel disease .
  5. Previous abdominal or pelvic radiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study group
gum chewing during spinal anesthesia and early ambulation
Procedure: gum chewing
chewing gum orally for 30 minutes
NO_INTERVENTION: Control group
no gum chewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of hospital stay
Time Frame: 48 hours
time of postoperative recovery of gastrointestinal tract
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • POSCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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