Prophylactic Pregabalin to Decrease Pain During Medical Abortion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsule with excipient to match Pregabalin

Interventions

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Pregabalin

Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

Intervention Type DRUG

Placebo

Matching placebo capsule with excipient to match Pregabalin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No