Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

NCT ID: NCT02332278

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Complications; Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early feeding

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

Group Type EXPERIMENTAL

Early feeding

Intervention Type PROCEDURE

Fluid diet four hours after cesarean section

Late feeding

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

Group Type ACTIVE_COMPARATOR

Late feeding

Intervention Type PROCEDURE

Fluid diet 12 hours after cesarean section

Interventions

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Early feeding

Fluid diet four hours after cesarean section

Intervention Type PROCEDURE

Late feeding

Fluid diet 12 hours after cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Lia Becerra, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Osvaldo Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas H

Panama City, Provincia de Panamá, Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2014-08

Identifier Type: -

Identifier Source: org_study_id

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