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Trial record 17 of 277 for:    Panama

Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

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ClinicalTrials.gov Identifier: NCT02332278
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.

Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Procedure: Early feeding Procedure: Late feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.
Study Start Date : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early feeding
Early feeding (fluid diet), four hours after cesarean section.
Procedure: Early feeding
Fluid diet four hours after cesarean section

Active Comparator: Late feeding
Late feeding (fluid diet) 12 hours after cesarean section.
Procedure: Late feeding
Fluid diet 12 hours after cesarean section




Primary Outcome Measures :
  1. Adynamic ileus [ Time Frame: 72 hours ]
    Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding


Secondary Outcome Measures :
  1. Post operative pain [ Time Frame: 72 hours ]
    Level of pain, using a visual scale (12, 24, 48 and 72 hours after surgery)

  2. Satisfaction [ Time Frame: 72 hours ]
    Personal satisfaction, using a numeric scale (12, 24, 48 and 72 hours after surgery)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cesarean section with regional anesthesia, regardless of gestational age.

Exclusion Criteria:

  • Use of magnesium sulphate
  • General anesthesia
  • Pre gestational or gestational diabetes
  • Bowel injury during surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332278


Locations
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Panama
Saint Thomas H
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Principal Investigator: Ana Lia Becerra, MD Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Coordinator of research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT02332278     History of Changes
Other Study ID Numbers: MHST2014-08
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Cesarean section
Early feeding