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Enemas Before Elective Cesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00391599
First Posted: October 24, 2006
Last Update Posted: April 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samuel Lurie, Wolfson Medical Center
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 Samuel Lurie, Wolfson Medical Center:

Primary Outcome Measures:
  • Number of Participants With Bowel Sounds [ Time Frame: On postoperative day 1 ]
    bowel sounds: present

  • Number of Participants With Gas Passage [ Time Frame: On postoperative day 1 ]
    gas passage: present

  • Number of Participants Had Spontaneous Feces [ Time Frame: On postoperative day 1 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cesarean Section, Elective
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391599


Sponsors and Collaborators
Wolfson Medical Center
Investigators
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
First Submitted: October 22, 2006
First Posted: October 24, 2006
Results First Submitted: December 18, 2015
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016
Last Verified: January 2016

Keywords provided by Samuel Lurie, Wolfson Medical Center:
Cesarean Section,
Enema


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