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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02396563
Other study ID # LABORCA
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 11, 2015
Last updated March 8, 2016
Start date June 2016
Est. completion date December 2017

Study information

Verified date March 2016
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Nulliparous

- > 18 years old

- term (>37 weeks gestation)

- singleton

- vertex pregnancies

Exclusion Criteria:

- Non-vertex presentation

- cervical dilation > 4.0cm

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
epidural analgesia

Drug:
Ropivacaine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Cagliari

Outcome

Type Measure Description Time frame Safety issue
Primary duration of labor Onset of contractions or rupture of membrances to delivery No
Secondary Presence or absence of fetal heart rate decelerations Time of first analgesic dose to 60 minutes Yes
Secondary fetal tachycardia Time of first analgesic dose to 60 minutes Yes
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