Complications After Cesarean SectionPhase 2NCT00391599
Enemas Before Elective Cesarean Section
A Phase 2 study testing enema in people with Complications After Cesarean Section, run by Wolfson Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Complications After Cesarean Section
- What is being tested?
- enema
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cesarean Section, Elective
Who cannot join
None listed.
About this study
Official title: 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.
- Conditions
- Complications After Cesarean Section
- Being tested
- enema
- Keywords
- Cesarean Section,, Enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enemaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section Receives: Procedure: enema |
| Control Group | Active comparator | no preoperative intestinal preparation. Receives: Procedure: enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Bowel Sounds
bowel sounds: present
Measured: On postoperative day 1
Number of Participants With Gas Passage
gas passage: present
Measured: On postoperative day 1
Number of Participants Had Spontaneous Feces
occurrence of spontaneous feces
Measured: On postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startJan 2009
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications After Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Samuel Lurie, Wolfson Medical Center
- Investigators
- Samuel Lurie, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391599
- Sponsor's protocol ID
- OS-SL-002
- Status last verified
- Jan 2016
- First submitted
- 22 Oct 2006
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lurie S, Baider C, Glickman H, Golan A, Sadan O. Are enemas given before cesarean section useful? A prospective randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):27-9. doi: 10.1016/j.ejogrb.2012.03.034. Epub 2012 Apr 17.
PubMed 22516178
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Enemas Given Before Elective Cesarean Section Useful?
- ClinicalTrials.gov ID
- NCT00391599
- Acronym / sponsor ID
- OS-SL-002
- Conditions
- Complications After Cesarean Section
- Keywords
- Cesarean Section,, Enema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- First posted
- 24 Oct 2006 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: enemaa fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section |
| Control Group | Active comparator | Procedure: enemano preoperative intestinal preparation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cesarean Section, Elective
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enema | Procedure or surgery | Control Group, Study Group |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22516178Lurie S, Baider C, Glickman H, Golan A, Sadan O. Are enemas given before cesarean section useful? A prospective randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):27-9. doi: 10.1016/j.ejogrb.2012.03.034. Epub 2012 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Lurie, MD principal investigator
Edith Wolfson Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing enema in people with Complications After Cesarean Section, run by Wolfson Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Bowel Sounds (time frame: On postoperative day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.