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Enemas Before Elective Cesarean Section

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ClinicalTrials.gov Identifier: NCT00391599
Recruitment Status : Completed
First Posted : October 24, 2006
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Samuel Lurie, Wolfson Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Complications After Cesarean Section Procedure: enema Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Are Enemas Given Before Elective Cesarean Section Useful?
Study Start Date : January 2009
Actual Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


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

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

  3. Number of Participants Had Spontaneous Feces [ Time Frame: On postoperative day 1 ]
    occurrence of spontaneous feces


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: October 24, 2006    Key Record Dates
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