NCT02782169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 19, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

November 30, 2015

Results QC Date

January 24, 2018

Last Update Submit

April 17, 2018

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Maximum Pain Score Over Study Period

    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 Outcomes (4)

  • Number of Ibuprofen 800mg Tablets Used

    Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)

  • Number of Oxycodone/Acetominophen Tablets (5/325mg) Used

    Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)

  • Number of Participants Ever Experiencing Different Symptoms During Abortion

    Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)

  • Satisfaction With Analgesia

    Asked at time point of 24 hours

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR
Drug: Pregabalin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PregabalinDRUG

Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

Pregabalin
PlaceboDRUG

Matching placebo capsule with excipient to match Pregabalin

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Options Center

Honolulu, Hawaii, 96826, United States

Location

Related Publications (2)

  • Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2.

    PMID: 35553047DERIVED

  • Friedlander EB, Soon R, Salcedo J, Davis J, Tschann M, Kaneshiro B. Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):612-618. doi: 10.1097/AOG.0000000000002787.

    PMID: 30095762DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Family Planning Department
Organization
University of Hawaii
hawaiimedab@gmail.com
808-983-6000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 30, 2015

First Posted

May 25, 2016

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

April 19, 2018

Results First Posted

April 19, 2018

Record last verified: 2018-04

Locations

US(1)