Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes

• Conditions: Labor; Epidural Analgesia; Nulliparous
• Interventions: Procedure: epidural analgesia; Drug: Ropivacaine

• Registration Number: NCT02396563
• Lead Sponsor: University of Cagliari

Brief Summary

The purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients, while the duration of the second stage will be longer in patient with analgesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-24
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09
• Study Start: 2016-06
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Nulliparous
• > 18 years old
• term (>37 weeks gestation)
• singleton
• vertex pregnancies

Exclusion Criteria

• Non-vertex presentation
• cervical dilation > 4.0cm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
epidural analgesia	epidural analgesia	women in labor with epidural analgesia
epidural analgesia	Ropivacaine	women in labor with epidural analgesia

Primary Outcome Measures

Name	Time	Method
duration of labor	Onset of contractions or rupture of membrances to delivery

Secondary Outcome Measures

Name	Time	Method
Presence or absence of fetal heart rate decelerations	Time of first analgesic dose to 60 minutes
fetal tachycardia	Time of first analgesic dose to 60 minutes