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NCT02332278 Clinical Trial

Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

Complications; Cesarean Section Clinical Trial

Official title:
Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02332278
Other study ID # MHST2014-08
Secondary ID
Status Completed
Phase N/A
First received January 4, 2015
Last updated January 4, 2015
Start date June 2014
Est. completion date December 2014

Study information
Verified date January 2015
Source Saint Thomas Hospital, Panama
Contact n/a
Is FDA regulated No
Health authority Panama: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 444
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• Early feeding
Fluid diet four hours after cesarean section
• Late feeding
Fluid diet 12 hours after cesarean section

Locations
Country Name City State
Panama Saint Thomas H Panama

Sponsors (1)
Lead Sponsor Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adynamic ileus Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding 72 hours Yes
Secondary Post operative pain Level of pain, using a visual scale (12, 24, 48 and 72 hours after surgery) 72 hours No
Secondary Satisfaction Personal satisfaction, using a numeric scale (12, 24, 48 and 72 hours after surgery) 72 hours No
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