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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Complications After Cesarean Section | Procedure: enema | Phase 2 |
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 |

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 |
- 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

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cesarean Section, Elective

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
Principal Investigator: | Samuel Lurie, MD | Edith Wolfson Medical Center |
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 |