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

April 25, 2017 updated by: San Giovanni Calibita Fatebenefratelli Hospital

Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

268

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00186
        • Recruiting
        • San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital
        • Contact:
        • Principal Investigator:
          • Claudia Claroni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SC
this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor
Drug: Clonidine
Intrathecal clonidine addiction
Active Comparator: S
this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor
Drug: Sufentanil
Intrathecal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local anesthetic consumption reduction
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Giovanni Calibita Fatebenefratelli Hospital

Investigators

  • Principal Investigator: Claudia Claroni, MD, Fatebenefratelli San Giovanni Calibita - Tiberine Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01.17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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