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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566498
Other study ID # IMOH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date April 2018

Study information

Verified date June 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum vomiting through a questionnaire patients were asked if they had vomiting or not and the nomber of attacks of vomitting 48 hours
Secondary Return of intestinal movements through physical examination and auscultation of the intestinal sounds 24 hours
Secondary Duration of intravenous fluid administration 24 hours
Secondary Duration of hospital stay 48 hours
Secondary Participant satisfaction through a questionnaire patients were asked about degree of satisfaction
1- satisfied 2- neutral 3- not satisfied
48 hours
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