Enemas Before Elective Cesarean Section

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samuel Lurie, Wolfson Medical Center

ClinicalTrials.gov Identifier:

NCT00391599

First received: October 22, 2006

Last updated: March 5, 2016

Last verified: January 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Complications After Cesarean Section	Procedure: enema	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Are Enemas Given Before Elective Cesarean Section Useful?

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:

Number of Participants With Bowel Sounds [ Time Frame: On postoperative day 1 ] [ Designated as safety issue: No ]
bowel sounds: present
Number of Participants With Gas Passage [ Time Frame: On postoperative day 1 ] [ Designated as safety issue: No ]
gas passage: present
Number of Participants Had Spontaneous Feces [ Time Frame: On postoperative day 1 ] [ Designated as safety issue: No ]
occurrence of spontaneous feces


Enrollment:	130
Study Start Date:	January 2009
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Procedure: enema
Active Comparator: Control Group no preoperative intestinal preparation.	Procedure: enema

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cesarean Section, Elective

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391599

Sponsors and Collaborators

Wolfson Medical Center

Investigators


Principal Investigator:	Samuel Lurie, MD	Edith Wolfson Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Samuel Lurie, Porfessor, Wolfson Medical Center
ClinicalTrials.gov Identifier:	NCT00391599 History of Changes
Other Study ID Numbers:	OS-SL-002
Study First Received:	October 22, 2006
Results First Received:	December 18, 2015
Last Updated:	March 5, 2016
Health Authority:	Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:


Cesarean Section, Enema

ClinicalTrials.gov processed this record on September 23, 2016

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