NCT02332278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 4, 2015

Last Update Submit

January 4, 2015

Conditions

Complications; Cesarean Section

Keywords

Cesarean sectionEarly feeding

Outcome Measures

Primary Outcomes (1)

  • Adynamic ileus

    Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding

    72 hours

Secondary Outcomes (2)

  • Post operative pain

    72 hours

  • Satisfaction

    72 hours

Study Arms (2)

Early feeding

EXPERIMENTAL

Early feeding (fluid diet), four hours after cesarean section.

Procedure: Early feeding

Late feeding

ACTIVE COMPARATOR

Late feeding (fluid diet) 12 hours after cesarean section.

Procedure: Late feeding

Interventions

Early feedingPROCEDURE

Fluid diet four hours after cesarean section

Early feeding
Late feedingPROCEDURE

Fluid diet 12 hours after cesarean section

Late feeding

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Location

Study Officials

  • Ana Lia Becerra, MD

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

  • Osvaldo Reyes, MD

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of research

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

June 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

PA(1)