NCT02416141

Brief Summary

If a termination of pregnancy procedure is performed by vacuum aspiration our patients receive a paracervical block. Nevertheless these patients are not free of pain. We randomised our patients: one group will receive additional orodispersible tramadol, the other group will receive a placebo.

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
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2015

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

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 14, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

March 31, 2015

Last Update Submit

April 8, 2015

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

  • Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.

    6 to 8 month to include all patients

Study Arms (2)

Fast release oro-dispersible tramadol

ACTIVE COMPARATOR

This group receives a fast release oro-dispersible tramadol 30 minutes before the vacuum aspiration procedure. A paracervical block with a 27-gauge spinal needle with lidocaine will be injected at the the start of the procedure. Intervention: use of fast release oro dispersible tramadol 50 mg

Drug: fast release oro dispersible tramadol 50 mg

Placebo-controlled arm

PLACEBO COMPARATOR

This group receives a placebo 30 minutes before the vacuum aspiration procedure. A paracervical block with a 27-gauge spinal needle with lidocaine will be injected at the the start of the procedure. Intervention: use of placebo

Interventions

fast release oro dispersible tramadol 50 mgDRUG

idem arm 1

Fast release oro-dispersible tramadol

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients above 18 ans.
  • Non desired pregnancy.
  • Non evolutive pregnancy.
  • Pregnancy \< or = 14 weeks of amenorrhea.

You may not qualify if:

  • \- Interruption of pregnancy due to medical reasons
  • Patient already included in this study
  • Intolerance for Tradonal Odis 50mg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversitairZB

Jette, Belgium

Location

Study Officials

  • Michael De Brucker

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael De Brucker, MD

CONTACT

003224776699

Study Design

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

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 14, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

April 14, 2015

Record last verified: 2015-03

Locations

BE(1)