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

NCT03925129 | Completed

• 1 other identifier: TENS MAB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion in First Trimester

Outcome Measures

Primary Outcomes (1)

• Pain on numeric rating scale

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

  8 hours following misoprostol

Study Arms (2)

TENS

EXPERIMENTAL

Device: high frequency TENS treatment

Sham TENS

SHAM COMPARATOR

Device: Sham TENS treatment

Interventions

high frequency TENS treatment DEVICE

Treatment with high frequency for minimum of 1 hour after misoprostol administration

TENS

Sham TENS treatment DEVICE

Treatment with sham TENS device for minimum of 1 hour after misoprostol administration

Sham TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Planned Parenthood of Greater New York: lead

Study Sites (1)

Planned Parenthood of New York City - Margaret Sanger Center

New York, New York, 10012, United States

Location

Related Publications (1)

• Goldman AR, Porsch L, Hintermeister A, Dragoman M. Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):100-107. doi: 10.1097/AOG.0000000000004208.

  PMID: 33278292 DERIVED

Study Officials

• Ariella Goldman, MD

  Planned Parenthood of Greater New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: June 11, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 13, 2020
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)