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

March 8, 2016 updated by: Stefano Angioni, University of Cagliari
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who come to the Gynecological nd obstetric Department of University Hospital to deliver

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-vertex presentation
  • cervical dilation > 4.0cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
epidural analgesia
women in labor with epidural analgesia
Drug: Ropivacaine
Procedure: epidural analgesia
no epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of labor
Time Frame: Onset of contractions or rupture of membrances to delivery
Onset of contractions or rupture of membrances to delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence or absence of fetal heart rate decelerations
Time Frame: Time of first analgesic dose to 60 minutes
Time of first analgesic dose to 60 minutes
fetal tachycardia
Time Frame: Time of first analgesic dose to 60 minutes
Time of first analgesic dose to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LABORCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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