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
  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:


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
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):
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 July 21, 2016