Early Versus Late Hydration After Cesarean Section (CS)

NCT02630810 | Completed DMC

• 1 other identifier: EVLHACS 1
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Motility and Defaecation Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to passage of first flatus

  Up to 48 hours following the Cesarean Section

• Time to first bowel motion

  Up to 3 days (72 hours) following Cesarean Section

• time to 1st breast feed

  First 24 hours after the Cesarean Section

Study Arms (2)

Early oral hydration

EXPERIMENTAL

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

Delayed oral hydration

ACTIVE COMPARATOR

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

Interventions

Early oral hydration OTHER

starting oral hydration 1 hour following Cesarean Section using 100 ml clear water

Early oral hydration

Delayed oral hydration OTHER

starting oral hydration 6 hours following Cesarean Section using 100 ml clear water

Delayed oral hydration

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, 11566, Egypt

Location

Study Officials

• Amr Yehia, Lecturer

  ainshams maternity hospital

  PRINCIPAL INVESTIGATOR

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: Lecturer in Obstetrics and Gynaecology

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)