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Urinary Catheterization and Second Stage of Labor (cath2stage)

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ClinicalTrials.gov Identifier: NCT02198157
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel

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

Condition or disease Intervention/treatment Phase
Labor, Second Stage Other: urinary catheterization Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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 Name: 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 Name: continuous versus intermittent catheterization.




Primary Outcome Measures :
  1. duration of second stage of labor [ Time Frame: within the first 48 hours after delivery ]

Secondary Outcome Measures :
  1. chorioamnionitis [ Time Frame: within the first 48 hours after delivery ]

Other Outcome Measures:
  1. post-partum hemorrhage [ Time Frame: within the first 48 hours after delivery ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198157


Locations
Israel
Dep. OB/GYN, HaEmek Medical Center
Afula, Israel
Sponsors and Collaborators
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

Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02198157     History of Changes
Other Study ID Numbers: 45-14-EMC
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Raed Salim, HaEmek Medical Center, Israel:
duration of second stage
urinary catheterization
epidural anaesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs