- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370708
Early Oral Intake Following Cesarean Surgery
September 6, 2006 updated by: Tehran University of Medical Sciences
Early Oral Intake Following Elective Cesarean Surgery in Iranian Women; the Economic Burdens and Patient Satisfaction
In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cesarean delivery is announced to constitute 50% of deliveries in the Capital and 39% of all the deliveries nationwide, which is far beyond the acceptable international normal range, according to the official site of the Ministry of Health and Medical Education of the Islamic Republic of Iran [http://www.mohme.gov.ir/HNDC/Indicators/Simaye_Salamt/Simaye_Salamat.htm].
This high rate of elective cesarean deliveries might be due to several reasons which are far beyond the scope of this study.
Here we tried to see whether the reduction in the time of hospitalization for these patients is safe at the expense of earlier oral realimentation and to see whether this strategy increases the patients' satisfaction or not.
Study Type
Interventional
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
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-
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Tehran, Iran, Islamic Republic of, 19986
- Department of Obstetrics and Gynecology, Arash Hospital
-
-
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:
Women who had elective cesarean deliveries under regional anesthesia
Exclusion Criteria:
- Receiving general anesthesia, magnesium sulfate or insulin.
- Coming across an intraoperative bowel injury.
- Having any medical or gastrointestinal problem that prohibits early feeding
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Tolerance of Oral Intake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Afsaneh Tehranian, Assist Pro, Department of Obstetrics and Gynecology, Arash Hospital, Tehran University of Medical Sciences, Tehran/Iran
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
April 1, 2003
Study Completion
February 1, 2004
Study Registration Dates
First Submitted
August 31, 2006
First Submitted That Met QC Criteria
August 31, 2006
First Posted (Estimate)
September 1, 2006
Study Record Updates
Last Update Posted (Estimate)
September 7, 2006
Last Update Submitted That Met QC Criteria
September 6, 2006
Last Verified
April 1, 2004
More Information
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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