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

NCT03566498 | Completed DMC

• 1 other identifier: IMOH
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Postpartum vomiting

  through a questionnaire patients were asked if they had vomiting or not and the nomber of attacks of vomitting

  48 hours

Secondary Outcomes (4)

• Return of intestinal movements

  24 hours

• Duration of intravenous fluid administration

  24 hours

• Duration of hospital stay

  48 hours

• Participant satisfaction

  48 hours

Study Arms (2)

Immediate hydration

EXPERIMENTAL

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.

Dietary Supplement: Immediate hydration

Early hydration

ACTIVE COMPARATOR

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.

Dietary Supplement: Early hydration

Interventions

Immediate hydration 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

Immediate hydration

Early hydration 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.

Early hydration

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Uncomplicated pregnancy.
• Uncomplicated elective or emergency Caesarean section under regional anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

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: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 25, 2018
• Study Start: August 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06