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 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 Samuel Lurie, Wolfson Medical Center:

Primary Outcome Measures:

Number of Participants With Bowel Sounds [ Time Frame: On postoperative day 1 ]
bowel sounds: present
Number of Participants With Gas Passage [ Time Frame: On postoperative day 1 ]
gas passage: present
Number of Participants Had Spontaneous Feces [ Time Frame: On postoperative day 1 ]
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)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cesarean Section, Elective

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Samuel Lurie, Wolfson Medical Center:


Cesarean Section, Enema

ClinicalTrials.gov processed this record on June 23, 2017

To Top