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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Dietary supplement: Immediate hydration; Dietary supplement: Early hydration

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum vomiting	through a questionnaire patients were asked if they had vomiting or not and the nomber of attacks of vomitting	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of intestinal movements	through physical examination and auscultation of the intestinal sounds	24 hours
Duration of intravenous fluid administration		24 hours
Duration of hospital stay		48 hours
Participant satisfaction	through a questionnaire patients were asked about degree of satisfaction 1- satisfied 2- neutral 3- not satisfied	48 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IMOH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No