NCT00370708

Brief Summary

In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Last Updated

September 7, 2006

Status Verified

April 1, 2004

First QC Date

August 31, 2006

Last Update Submit

September 6, 2006

Conditions

ObstetricsSurgery

Keywords

CesareanOralIntake

Outcome Measures

Primary Outcomes (1)

  • Tolerance of Oral Intake

Interventions

Oral Intake following admittance to the postpartum wardPROCEDURE

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who had elective cesarean deliveries under regional anesthesia

You may not qualify if:

  • Receiving general anesthesia, magnesium sulfate or insulin.
  • Coming across an intraoperative bowel injury.
  • Having any medical or gastrointestinal problem that prohibits early feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Arash Hospital

Tehran, Tehran Province, 19986, Iran

Location

Study Officials

  • Afsaneh Tehranian, Assist Pro

    Department of Obstetrics and Gynecology, Arash Hospital, Tehran University of Medical Sciences, Tehran/Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

April 1, 2003

Study Completion

February 1, 2004

Last Updated

September 7, 2006

Record last verified: 2004-04

Locations

IR(1)