Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

NCT ID: NCT03018171

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SC

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

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Intrathecal clonidine addiction

S

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

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intrathecal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clonidine

Intrathecal clonidine addiction

Intervention Type DRUG

Sufentanil

Intrathecal

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

San Giovanni Calibita Fatebenefratelli Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claudia Claroni, MD

Role: PRINCIPAL_INVESTIGATOR

Fatebenefratelli San Giovanni Calibita - Tiberine Island

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital

Rome, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maria Grazia Frigo, MD

Role: CONTACT

+39066837258

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marco Aversano, MD

Role: primary

+39066837258

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01.17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.