Enemas Before Elective Cesarean Section
March 5, 2016 updated by: Samuel Lurie, Wolfson Medical Center
Are Enemas Given Before Elective Cesarean Section Useful?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Cesarean Section, Elective
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
|
|
ACTIVE_COMPARATOR: Control Group
no preoperative intestinal preparation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Bowel Sounds
Time Frame: On postoperative day 1
|
bowel sounds: present
|
On postoperative day 1
|
|
Number of Participants With Gas Passage
Time Frame: On postoperative day 1
|
gas passage: present
|
On postoperative day 1
|
|
Number of Participants Had Spontaneous Feces
Time Frame: On postoperative day 1
|
occurrence of spontaneous feces
|
On postoperative day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samuel Lurie, MD, Edith Wolfson Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
October 22, 2006
First Submitted That Met QC Criteria
October 23, 2006
First Posted (ESTIMATE)
October 24, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
April 4, 2016
Last Update Submitted That Met QC Criteria
March 5, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OS-SL-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.