Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

Completed · Not applicable · Has a placebo group

Conditions studied: Abortion in First Trimester

In brief

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.

Key facts

Study ID

NCT03925129

Run by

Planned Parenthood of Greater New York

People needed

40

Starts

2019-06-11

Expected to finish

2020-03-13

Last updated by the study team

2021-04-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Planned Parenthood of New York City - Margaret Sanger Center — New York, New York, United States

Full record on ClinicalTrials.gov

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