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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03925129

Recruitment Status Completed

First Posted April 24, 2019

Last update posted September 30, 2020

Study Description

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.

  • Condition or Disease:Abortion in First Trimester
  • Intervention/Treatment: Device: high frequency TENS treatment
    Device: Sham TENS treatment
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Arms and interventions
Arm Intervention/treatment
Experimental: TENS
Device: high frequency TENS treatment
Treatment with high frequency for minimum of 1 hour after misoprostol administration
Sham Comparator: Sham TENS
Device: Sham TENS treatment
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration
Outcome Measures
  • Primary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Patients seeking medication abortion with a definite, singleton, intrauterine
pregnancy (IUP) 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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Planned Parenthood of Greater New York

More Information
  • Responsible Party: Planned Parenthood of Greater New York
  • ClinicalTrials.gov Identifier: NCT03925129 History of Changes
  • Other Study ID Numbers: TENS MAB
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 30, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes