Enemas Before Elective Cesarean Section

This study has been completed.
Information provided by (Responsible Party):
Samuel Lurie, Wolfson Medical Center
ClinicalTrials.gov Identifier:
First received: October 22, 2006
Last updated: March 5, 2016
Last verified: January 2016
Enemas are not anymore used routinely before vaginal deliveries.The intention of this study is to elucidate whether there is a benefit in routine use of enema before cesarean section.

Condition Intervention Phase
Complications After Cesarean Section
Procedure: enema
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Are Enemas Given Before Elective Cesarean Section Useful?

Resource links provided by NLM:

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Number of Participants With Bowel Sounds [ Time Frame: On postoperative day 1 ] [ Designated as safety issue: No ]
    bowel sounds: present

  • Number of Participants With Gas Passage [ Time Frame: On postoperative day 1 ] [ Designated as safety issue: No ]
    gas passage: present

  • Number of Participants Had Spontaneous Feces [ Time Frame: On postoperative day 1 ] [ Designated as safety issue: No ]
    occurrence of spontaneous feces

Enrollment: 130
Study Start Date: January 2009
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section
Procedure: enema
Active Comparator: Control Group
no preoperative intestinal preparation.
Procedure: enema


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cesarean Section, Elective
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391599

Sponsors and Collaborators
Wolfson Medical Center
Principal Investigator: Samuel Lurie, MD Edith Wolfson Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samuel Lurie, Porfessor, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT00391599     History of Changes
Other Study ID Numbers: OS-SL-002 
Study First Received: October 22, 2006
Results First Received: December 18, 2015
Last Updated: March 5, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
Cesarean Section,

ClinicalTrials.gov processed this record on May 23, 2016