NCT00391599

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

April 4, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

October 22, 2006

Results QC Date

December 18, 2015

Last Update Submit

March 5, 2016

Conditions

Complications After Cesarean Section

Keywords

Cesarean Section,Enema

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Bowel Sounds

    bowel sounds: present

    On postoperative day 1

  • Number of Participants With Gas Passage

    gas passage: present

    On postoperative day 1

  • Number of Participants Had Spontaneous Feces

    occurrence of spontaneous feces

    On postoperative day 1

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

no preoperative intestinal preparation.

Procedure: enema

Interventions

enemaPROCEDURE
Control GroupStudy Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cesarean Section, Elective

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22516178DERIVED

MeSH Terms

Interventions

Enema

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Investigator
Organization
Edith Wolfson Medical Center
lurie@wolfson.health.gov.il
+972-35028329

Study Officials

  • Samuel Lurie, MD

    Edith Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Porfessor

Study Record Dates

First Submitted

October 22, 2006

First Posted

October 24, 2006

Study Start

January 1, 2009

Primary Completion

October 1, 2011

Last Updated

April 4, 2016

Results First Posted

April 4, 2016

Record last verified: 2016-01