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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control Group | Active Comparator | no preoperative intestinal preparation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enema | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bowel Sounds | bowel sounds: present | On postoperative day 1 |
| Number of Participants With Gas Passage | gas passage: present | On postoperative day 1 |
| Number of Participants Had Spontaneous Feces | occurrence of spontaneous feces | On postoperative day 1 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Lurie, MD | Edith Wolfson Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22516178 | Derived | 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. |
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The inclusion criteria were elective cesarean section and no history of previous abdominal operations except for cesarean delivery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section |
| FG001 | Control Group | The patients had no preoperative intestinal preparation on the night before cesarean section |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 enema |
| BG001 | Control Group | no preoperative intestinal preparation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Bowel Sounds | bowel sounds: present | Posted | Number | participants | On postoperative day 1 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 enema the night before cesarean section |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Investigator | Edith Wolfson Medical Center | +972-35028329 | lurie@wolfson.health.gov.il |
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| ID | Term |
|---|---|
| D004733 | Enema |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
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| Primary | Number of Participants With Gas Passage | gas passage: present | Posted | Number | participants | On postoperative day 1 |
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|
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| Primary | Number of Participants Had Spontaneous Feces | occurrence of spontaneous feces | Posted | Number | participants | On postoperative day 1 |
|
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Control Group | no preoperative intestinal preparation. the night before cesarean section | 0 | 65 | 0 | 65 |
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