NCT02396563

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 11, 2015

Last Update Submit

March 8, 2016

Conditions

LaborEpidural AnalgesiaNulliparous

Outcome Measures

Primary Outcomes (1)

  • duration of labor

    Onset of contractions or rupture of membrances to delivery

Secondary Outcomes (2)

  • 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

Study Arms (2)

epidural analgesia

women in labor with epidural analgesia

Procedure: epidural analgesiaDrug: Ropivacaine

no epidural analgesia

Interventions

epidural analgesiaPROCEDURE
epidural analgesia
RopivacaineDRUG
epidural analgesia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Non-vertex presentation
  • cervical dilation \> 4.0cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Analgesia, EpiduralRopivacaine

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 24, 2015

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

March 9, 2016

Record last verified: 2016-03