NCT03018171

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

January 10, 2017

Last Update Submit

April 25, 2017

Conditions

Labor Pain

Keywords

clonidine, spinal injections

Outcome Measures

Primary Outcomes (1)

  • local anesthetic consumption reduction

    8 months

Study Arms (2)

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

ClonidineDRUG

Intrathecal clonidine addiction

SC
SufentanilDRUG

Intrathecal

S

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital

Rome, 00186, Italy

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

ClonidineSufentanil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFentanylPiperidines

Study Officials

  • Claudia Claroni, MD

    Fatebenefratelli San Giovanni Calibita - Tiberine Island

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Grazia Frigo, MD

CONTACT

+39066837258mariagrazia.frigo@fbf-isola.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 11, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IT(1)