Urinary Catheterization and Second Stage of Labor

NCT02198157 | Completed DMC

• 1 other identifier: 45-14-EMC
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Labor, Second Stage

Keywords

duration of second stage; urinary catheterization; epidural anaesthesia

Outcome Measures

Primary Outcomes (1)

• duration of second stage of labor

  within the first 48 hours after delivery

Secondary Outcomes (1)

• chorioamnionitis

  within the first 48 hours after delivery

Other Outcomes (1)

• post-partum hemorrhage

  within the first 48 hours after delivery

Study Arms (2)

intermittent urinary catheterization

ACTIVE COMPARATOR

nullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization

Other: urinary catheterization

continuous urinary catheter

ACTIVE COMPARATOR

nullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization

Other: urinary catheterization

Interventions

urinary catheterization OTHER

nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.

Also known as: continuous versus intermittent catheterization.

continuous urinary catheter; intermittent urinary catheterization

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Raed Salim: lead

Study Sites (1)

Dep. OB/GYN, HaEmek Medical Center

Afula, Israel

Location

MeSH Terms

Interventions

Urinary Catheterization

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• raed salim, MD

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

  STUDY DIRECTOR

• abeer suleiman, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

IL (1)