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Clinical Trials/NCT03925129
NCT03925129
Completed
Not Applicable

A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

Planned Parenthood of Greater New York1 site in 1 country40 target enrollmentJune 11, 2019
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ConditionsAbortion in First Trimester

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abortion in First Trimester
Sponsor
Planned Parenthood of Greater New York
Enrollment
40
Locations
1
Primary Endpoint
Pain on numeric rating scale
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a double-blinded, randomized, placebo-controlled trial evaluating the use of High-frequency Transcutaneous Electrical Nerve Stimulation (HfTENS) compared to sham TENS for pain control during medication abortion with mifepristone and misoprostol through 70 days' gestation.

Registry
clinicaltrials.gov
Start Date
June 11, 2019
End Date
March 13, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
Planned Parenthood of Greater New York
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patients seeking medication abortion with a definite, singleton, intrauterine pregnancy (IUP) \< 70 days' gestation on ultrasound
  • •Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score \> 4
  • •Age equal to or greater than 18 years
  • •Provide informed consent to participate
  • •Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone

Exclusion Criteria

  • •Contraindication to medication abortion
  • •Allergy to mifepristone or misoprostol
  • •Contraindication or allergy to ibuprofen
  • •History of cardiac arrhythmia
  • •Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker
  • •History of chronic pain disorder
  • •Any opioid use during previous 30 days
  • •Current or prior use of TENS
  • •BMI \> 30

Outcomes

Primary Outcomes

Pain on numeric rating scale

Time Frame: 8 hours following misoprostol

Maximum pain score on an 11-point numeric rating scale, where 0 is no pain, and 10 is the worst pain.

Study Sites (1)

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