Urinary Catheterization and Second Stage of Labor

Labor, Second Stage Clinical Trial

— cath2stage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198157
• Other study ID #: 45-14-EMC
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: February 20, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nulliparous women

• Gestational age 24-42 weeks

• epidural anaesthesia

• Vertex presentation

• Singleton

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor, Second Stage

Intervention

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

Locations

Country	Name	City	State
Israel	Dep. OB/GYN, HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Raed Salim

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post-partum hemorrhage		within the first 48 hours after delivery	Yes
Primary	duration of second stage of labor		within the first 48 hours after delivery	No
Secondary	chorioamnionitis		within the first 48 hours after delivery	Yes