Urinary Catheterization and Second Stage of Labor

NCT ID: NCT02198157

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intermittent urinary catheterization

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

Group Type: ACTIVE_COMPARATOR

urinary catheterization

Intervention Type: OTHER

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

continuous urinary catheter

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

Group Type: ACTIVE_COMPARATOR

urinary catheterization

Intervention Type: OTHER

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

Interventions

urinary catheterization

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

Intervention Type: OTHER

Other Intervention Names

continuous versus intermittent catheterization.

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Raed Salim

OTHER

Sponsor Role: lead

Responsible Party

Raed Salim

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

raed salim, MD

Role: STUDY_DIRECTOR

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

abeer suleiman, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Dep. OB/GYN, HaEmek Medical Center

Afula, , Israel

Countries

Israel

Other Identifiers

45-14-EMC

Identifier Type: -

Identifier Source: org_study_id