Enemas Before Elective Cesarean Section

NCT ID: NCT00391599

Last Updated: 2016-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Complications After Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

enema

Intervention Type PROCEDURE

Control Group

no preoperative intestinal preparation.

Group Type ACTIVE_COMPARATOR

enema

Intervention Type PROCEDURE

Interventions

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enema

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cesarean Section, Elective
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Samuel Lurie

Porfessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel Lurie, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

References

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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.

Reference Type DERIVED
PMID: 22516178 (View on PubMed)

Other Identifiers

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OS-SL-002

Identifier Type: -

Identifier Source: org_study_id

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