NCT02143089

Brief Summary

Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 6, 2014

Last Update Submit

May 16, 2014

Conditions

Wound Infection

Keywords

CCSWI

Outcome Measures

Primary Outcomes (1)

  • Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field

    participants will be followed for the duration of urinary tract infection,an expected average 2 days.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Use of urinary catheterization in Cesarean section

Device: Foley's Catheter

Group 2

NO INTERVENTION

NO urinary catheterization during Cesarean section

Interventions

Foley's CatheterDEVICE

Urinary tract infection inpatient catheterized versus non catheterized

Group 1

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age).

You may not qualify if:

  • Women with history of more than one previous caesarean Section.
  • Women with history of a tonic postpartum hemorrhage.
  • Women with Urinary tract infection in present pregnancy.
  • Women with diabetes mellitus in present pregnancy.
  • Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy.
  • Emergency caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShamsU

Cairo, +20, Egypt

RECRUITING

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Amr Helmy, Master

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ain Shams University

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 20, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

EG(1)