Effect of Epidural Analgesia on the Length of Labor and D... | NCT02396563

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

NCT02396563

Sponsor

University of Cagliari

Status

Unknown status

Last Update Posted

Mar 9, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Labor
Epidural Analgesia
Nulliparous

Interventions

epidural analgesia
Ropivacaine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 11, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2016

Last Update Posted Date

Mar 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
epidural analgesia		women in labor with epidural analgesia	Procedure: epidural analgesia Drug: Ropivacaine
no epidural analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epidural analgesia	Procedure		epidural analgesia
Ropivacaine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-vertex presentation
cervical dilation > 4.0cm

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D015360	Analgesia, Epidural
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia
D000813	Anilides
D000577	Amides

Browse Leaves

Not provided

Browse Branches

Not provided