Urinary Catheterization and Second Stage of Labor (cath2stage)

February 20, 2016 updated by: Raed Salim

Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration

  • Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta
  • The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes
  • Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural.
  • Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage
  • Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization.
  • Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage.
  • This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Dep. OB/GYN, HaEmek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous women
  • Gestational age 24-42 weeks
  • epidural anaesthesia
  • Vertex presentation
  • Singleton

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: intermittent urinary catheterization
nullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization
Other: urinary catheterization
nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.
Other Names:
  • continuous versus intermittent catheterization.
ACTIVE_COMPARATOR: continuous urinary catheter
nullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization
Other: urinary catheterization
nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.
Other Names:
  • continuous versus intermittent catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of second stage of labor
Time Frame: within the first 48 hours after delivery
within the first 48 hours after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
chorioamnionitis
Time Frame: within the first 48 hours after delivery
within the first 48 hours after delivery

Other Outcome Measures

Outcome Measure
Time Frame
post-partum hemorrhage
Time Frame: within the first 48 hours after delivery
within the first 48 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raed Salim

Investigators

  • Study Director: raed salim, MD, Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
  • Principal Investigator: abeer suleiman, MD, Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (ESTIMATE)

July 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 20, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 45-14-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor, Second Stage

Clinical Trials on urinary catheterization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe