Trial Outcomes & Findings for Enemas Before Elective Cesarean Section (NCT NCT00391599)

NCT ID: NCT00391599

Last Updated: 2016-04-04

Results Overview

bowel sounds: present

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 130 participants
• Primary outcome timeframe: On postoperative day 1
• Results posted on: 2016-04-04

Participant Flow

The inclusion criteria were elective cesarean section and no history of previous abdominal operations except for cesarean delivery.

Participant milestones

Measure	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	Control Group The patients had no preoperative intestinal preparation on the night before cesarean section
Overall Study STARTED	65	65
Overall Study COMPLETED	65	65
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enemas Before Elective Cesarean Section

Baseline characteristics by cohort

Measure	Study Group n=65 Participants a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section enema	Control Group n=65 Participants no preoperative intestinal preparation.	Total n=130 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 6.1 • n=93 Participants	31.3 years STANDARD_DEVIATION 5.3 • n=4 Participants	31.9 years STANDARD_DEVIATION 5.7 • n=27 Participants
Sex: Female, Male Female	65 Participants n=93 Participants	65 Participants n=4 Participants	130 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Israel	65 participants n=93 Participants	65 participants n=4 Participants	130 participants n=27 Participants

PRIMARY outcome

Timeframe: On postoperative day 1

bowel sounds: present

Outcome measures

Measure	Study Group n=65 Participants 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	Control Group n=65 Participants The patients had no preoperative intestinal preparation on the night before cesarean section
Number of Participants With Bowel Sounds	23 participants	31 participants

PRIMARY outcome

Timeframe: On postoperative day 1

gas passage: present

Outcome measures

Measure	Study Group n=65 Participants 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	Control Group n=65 Participants The patients had no preoperative intestinal preparation on the night before cesarean section
Number of Participants With Gas Passage	31 participants	34 participants

PRIMARY outcome

Timeframe: On postoperative day 1

occurrence of spontaneous feces

Outcome measures

Measure	Study Group n=65 Participants 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	Control Group n=65 Participants The patients had no preoperative intestinal preparation on the night before cesarean section
Number of Participants Had Spontaneous Feces	1 participants	7 participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Investigator

Edith Wolfson Medical Center

Phone: +972-35028329

Email: lurie@wolfson.health.gov.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place