Early Versus Traditional Oral Hydration After Cesarean Section

Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial

this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Motility and Defecation Conditions
• Intervention / Treatment: Other: Early Hydration; Other: Traditional Oral Hydration

Detailed Description

Traditionally, patients are not given fluids or food after cesarean sections until bowel function returns as evidenced by bowel sounds, passage of stool or flatus since , uneventful (uncomplicated) cesarean sections have no effect on intestinal functions and with putting in minds the need of the mother for early hydration , movement , breast feeding and early discharge; that is why we are investigating the effectiveness and safety of early oral hydration after cesarean sections

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Term Singleton Pregnancy.
• Uncomplicated Elective Cesarean Section.
• Time of Cesarean Section doesn't exceed 90 minutes.
• Average blood loss during and after cesarean section (doesn't exceed 1000cc).
• All patients will be under spinal anesthesia.

Exclusion Criteria:

• Postpartum Hemorrhage.
• Surgical Complications Such as intestinal injury.
• Medical disorders such as Diabetes and Hypertension
• Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos.
• Use of tocolytic drugs

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: Early Hydration Group; this study group will get 200 ml of sugar free water within 1 hour after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Early Oral Hydration	Other: Early Hydration; this group will start oral hydration within 1 hour after cesarean section; Other Names: Early Oral Hydration
Active Comparator: Traditional Hydration Group; this study group will get 200 ml of sugar free water after 6 hours after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Traditional Oral Hydration	Other: Traditional Oral Hydration; this group will start oral hydration 6 hours after cesarean section; Other Names: Delayed Oral Hydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
audible intestinal sounds	auscultation of intestinal sounds hourly for the first 12 hours after cesarean section	first 12 hours after cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative anorexia, nausea and vomiting	recording the incidence of git upset symptoms in the first 24 hours after cesarean section	first 24 hours after cesarean section
time for first breast feeding	recording the time of first breast-feed	first 24 hours after cesarean section
abdominal distension	recording the incidence of abdominal distension after cesarean section	first 24 hours after cesarean section
amount of given intravenous fluids	recording amount in ml of given iv fluids	up to 24 hours after cesarean section
need for pain analgesics	recording the amount of pain analgesia needed after cesarean section	up to 24 hours after cesarean section
length of hospital stay	recording the length of patients' stay at hospital	up to 48 hours after cesarean section
satisfaction measured with a visual analogue scale before patient discharge	measuring satisfaction level after cesarean section	first 6 hours after cesarean section
time to first flatus	recording the time at which the patient had its first flatus	up to 48 hours after cesarean section
time to first bowel movement	recording the time at which the patient had her first bowel motion	up to 72 hours after cesarean section

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Bassem A Islam, Lecturer, Ain Shams Maternity Hospital; Study Director: Karim A Wahba, Professor, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: cesarean section; bowel movements; oral hydration
• Other Study ID Numbers: cshydration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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