Early Versus Late Hydration After Cesarean Section (CS)

Early Versus Late Oral Hydration After Cesarean Section: A Randomized Controlled Study

This study evaluates the effect of early oral hydration on bowel movement after CS, it includes 2 groups: study group participants receive 100 ml water after 1hr from the end of CS, while the others receive water after 6hrs from the end of CS.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Motility and Defaecation Conditions
• Intervention / Treatment: Other: Early oral hydration; Other: Delayed oral hydration

Detailed Description

Traditionally, oral intake after CS was depend on insurance of intestinal movement, since uncomplicated CS does not affect the intestine and the mother needs to care of her infants, lactates, discharged from hospital, early oral hydration may enhance bowel movement, so the investigators need to evaluate the safety of early oral hydration after CS.

This study compare the effects of introducing water during the 1st hour or after 6 hours on bowel movement after CS.

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • 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:

• uncomplicated elective or emergency lower segment Caesarean section
• average blood loss during and after cs
• regional anaesthesia
• primary or recurrent CS

Exclusion Criteria:

• surgical complications esp; intestinal injury
• postpartum hemorrhage
• medical disorder with pregnancy eg. hypertension, diabetes mellitus
• factors that may increase risk of postpartum hemorrhage as twins pregnancy, polyhydramnios and anemia

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 oral hydration; Early oral intake of 100 ml clear unsweetened water 1 hour following the Cesarean Section, then upon patient's desire, then starting semisolid, solid food when participant passed flatus.	Other: Early oral hydration; starting oral hydration 1 hour following Cesarean Section using 100 ml clear water
Active Comparator: Delayed oral hydration; Oral intake of 100 ml clear unsweetened water after 6 hours from the end of CS then upon patient's request,then starting semisolid, solid food when participant passed flatus.	Other: Delayed oral hydration; starting oral hydration 6 hours following Cesarean Section using 100 ml clear water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to 1st audible intestinal sound	Auscultating intestinal sounds (using stethoscope) hourly for the first 12 hours after Cesarean Section till intestinal sounds are audible.	First 12 hours after Cesarean Section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to passage of first flatus	Recording the timing of passage of first flatus following Cesarean Section (up to the first 48 hours).	Up to 48 hours following the Cesarean Section
Time to first bowel motion	Recording the first time the pass stools after cesarean section (up to the first 72 hours).	Up to 3 days (72 hours) following Cesarean Section
time to 1st breast feed	Recording the first time to breastfeed after cesarean section (up to the first 24 hours).	First 24 hours after the Cesarean Section

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Amr Yehia, Lecturer, AinShams Maternity Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: EVLHACS 1

Plan for Individual participant data (IPD)

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