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Enemas Before Elective Cesarean Section

Are Enemas Given Before Elective Cesarean Section Useful?

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00391599
Enrollment
130
Registered
2006-10-24
Start date
2009-01-31
Completion date
Unknown
Last updated
2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications After Cesarean Section

Keywords

Cesarean Section,, Enema

Brief 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.

Interventions

PROCEDUREenema

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Cesarean Section, Elective

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Bowel SoundsOn postoperative day 1bowel sounds: present
Number of Participants With Gas PassageOn postoperative day 1gas passage: present
Number of Participants Had Spontaneous FecesOn postoperative day 1occurrence of spontaneous feces

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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
65
Control Group
no preoperative intestinal preparation.
65
Total130

Baseline characteristics

CharacteristicStudy GroupControl GroupTotal
Age, Continuous32.3 years
STANDARD_DEVIATION 6.1
31.3 years
STANDARD_DEVIATION 5.3
31.9 years
STANDARD_DEVIATION 5.7
Region of Enrollment
Israel
65 participants65 participants130 participants
Sex: Female, Male
Female
65 Participants65 Participants130 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 650 / 65
serious
Total, serious adverse events
0 / 650 / 65

Outcome results

Primary

Number of Participants Had Spontaneous Feces

occurrence of spontaneous feces

Time frame: On postoperative day 1

ArmMeasureValue (NUMBER)
Study GroupNumber of Participants Had Spontaneous Feces1 participants
Control GroupNumber of Participants Had Spontaneous Feces7 participants
p-value: <0.05Chi-squared
Primary

Number of Participants With Bowel Sounds

bowel sounds: present

Time frame: On postoperative day 1

ArmMeasureValue (NUMBER)
Study GroupNumber of Participants With Bowel Sounds23 participants
Control GroupNumber of Participants With Bowel Sounds31 participants
p-value: 0.15Chi-squared
Primary

Number of Participants With Gas Passage

gas passage: present

Time frame: On postoperative day 1

ArmMeasureValue (NUMBER)
Study GroupNumber of Participants With Gas Passage31 participants
Control GroupNumber of Participants With Gas Passage34 participants

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026