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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

Tracking Information
First Submitted Date  ICMJE January 4, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date January 6, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2015)
Adynamic ileus [ Time Frame: 72 hours ]
Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2015)
  • Post operative pain [ Time Frame: 72 hours ]
    Level of pain, using a visual scale (12, 24, 48 and 72 hours after surgery)
  • Satisfaction [ Time Frame: 72 hours ]
    Personal satisfaction, using a numeric scale (12, 24, 48 and 72 hours after surgery)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.
Official Title  ICMJE Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Complications; Cesarean Section
Intervention  ICMJE
  • Procedure: Early feeding
    Fluid diet four hours after cesarean section
  • Procedure: Late feeding
    Fluid diet 12 hours after cesarean section
Study Arms  ICMJE
  • Experimental: Early feeding
    Early feeding (fluid diet), four hours after cesarean section.
    Intervention: Procedure: Early feeding
  • Active Comparator: Late feeding
    Late feeding (fluid diet) 12 hours after cesarean section.
    Intervention: Procedure: Late feeding
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2015)
444
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02332278
Other Study ID Numbers  ICMJE MHST2014-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor  ICMJE Saint Thomas Hospital, Panama
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ana Lia Becerra, MD Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
PRS Account Saint Thomas Hospital, Panama
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP