The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes

NCT ID: NCT03566498

Last Updated: 2018-06-25

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-04-30

Brief Summary

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The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section

Detailed Description

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The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section on the following post-operative outcomes:

1. Post-operative nausea, vomiting, abdominal distention and abdominal cramps.
2. Return of intestinal movements.
3. Duration of intravenous fluid administration.
4. Duration of hospital stay.
5. Participant satisfaction

Conditions

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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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Immediate hydration

They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements.

Group Type EXPERIMENTAL

Immediate hydration

Intervention Type DIETARY_SUPPLEMENT

They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements

Early hydration

They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.

Group Type ACTIVE_COMPARATOR

Early hydration

Intervention Type DIETARY_SUPPLEMENT

They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.

Interventions

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Immediate hydration

They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements

Intervention Type DIETARY_SUPPLEMENT

Early hydration

They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* • Uncomplicated pregnancy.

* Uncomplicated elective or emergency Caesarean section under regional anesthesia

Exclusion Criteria

* • Having medical disorders in the form of: hypertension, DM, and Hepatic disorders.

* Having bleeding disorders.
* Having intraoperative bowel or bladder injury.
* Having intraoperative or immediate postoperative severe bleeding.
* Having chronic gastrointestinal problems, like chronic constipation, peptic ulcer, esophagitis, hiatus hernia or irritable bowel syndrome.
* Having abdominal adhesions
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdel Shafy El Shahawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IMOH

Identifier Type: -

Identifier Source: org_study_id

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