Prophylactic Pregabalin to Decrease Pain During Medical Abortion

April 17, 2018 updated by: University of Hawaii

Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial

Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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 Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Women's Options Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Requested and consented for pregnancy termination by medical abortion
  • Willing and able to complete multiple electronic surveys

Exclusion Criteria:

  • Previous participation in this trial
  • Current use of pregabalin or gabapentin
  • Contraindication to medical abortion with mifepristone and misoprostol
  • Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin
  • Unable to understand and sign written informed consents in English

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Matching placebo capsule with excipient to match Pregabalin
ACTIVE_COMPARATOR: Pregabalin
Drug: Pregabalin
Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Pain Score Over Study Period
Time Frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain
Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Ibuprofen 800mg Tablets Used
Time Frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
summed number of tablets used by each participant over the 72 hour study period
Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used
Time Frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
summed number of tablets used by each participant over the 72 hour study period
Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Number of Participants Ever Experiencing Different Symptoms During Abortion
Time Frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.
Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Satisfaction With Analgesia
Time Frame: Asked at time point of 24 hours
5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)
Asked at time point of 24 hours

Collaborators and Investigators

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

Sponsor

University of Hawaii

Collaborators

Society of Family Planning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

May 20, 2016

First Posted (ESTIMATE)

May 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFPRF15-12

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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