Intrathecal Clonidine Addiction for Combined Spinal Epidu... | NCT03018171

Studies
Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

NCT03018171

Sponsor

San Giovanni Calibita Fatebenefratelli Hospital

Status

Unknown status

Last Update Posted

Apr 27, 2017Actual

Enrollment

268Estimated

Phase

Phase 4

Conditions

Labor Pain

Interventions

Clonidine
Sufentanil

Countries

Italy

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Jun 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 10, 2017

First Posted Date

Jan 11, 2017Estimated

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

Apr 25, 2017

Last Update Posted Date

Apr 27, 2017Actual

Description Module

Brief Summary

The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

268Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SC	Experimental	this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor	Drug: Clonidine
S	Active Comparator	this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor	Drug: Sufentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clonidine	Drug	Intrathecal clonidine addiction	SC
Sufentanil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
local anesthetic consumption reduction		8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written maternal informed consent
Singleton pregnancy
Gestational age ≥ 37 weeks,
ASA I
BMI < 30
fetus in cephalic presentation

Exclusion Criteria:

Suspect or certainty of fetal malformation,
Presence of conditions such as preeclampsia, multiparity, preterm labor
History of adverse reaction to α-2 adrenergic agonists
Nicotine addiction
Chronic use of opioid

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Grazia Frigo, MD	Contact	+39066837258		mariagrazia.frigo@fbf-isola.it

Overall Officials

Name	Affiliation	Role
Claudia Claroni, MD	Fatebenefratelli San Giovanni Calibita - Tiberine Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital	Recruiting	Rome		00186	Italy

Condition Browse Module

MeSH Terms

ID	Term
D048949	Labor Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003000	Clonidine
D017409	Sufentanil

Ancestor Terms

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided