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Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor (ICA)

Primary Purpose

Labor Pain

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Clonidine
Sufentanil
Sponsored by
San Giovanni Calibita Fatebenefratelli Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring clonidine, spinal injections

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Giovanni Calibita Fatebenefratelli, Tiberine Island, HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SC

S

Arm Description

this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor

this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor

Outcomes

Primary Outcome Measures

local anesthetic consumption reduction

Secondary Outcome Measures

Full Information

First Posted
January 10, 2017
Last Updated
April 25, 2017
Sponsor
San Giovanni Calibita Fatebenefratelli Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03018171
Brief Title
Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor
Acronym
ICA
Official Title
Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Giovanni Calibita Fatebenefratelli Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
clonidine, spinal injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SC
Arm Type
Experimental
Arm Description
this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor
Arm Title
S
Arm Type
Active Comparator
Arm Description
this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
Intrathecal clonidine addiction
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
Intrathecal
Primary Outcome Measure Information:
Title
local anesthetic consumption reduction
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Grazia Frigo, MD
Phone
+39066837258
Email
mariagrazia.frigo@fbf-isola.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Claroni, MD
Organizational Affiliation
Fatebenefratelli San Giovanni Calibita - Tiberine Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital
City
Rome
ZIP/Postal Code
00186
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Aversano, MD
Phone
+39066837258
Email
m.aversano@me.com
First Name & Middle Initial & Last Name & Degree
Claudia Claroni, MD

12. IPD Sharing Statement

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Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

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