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

NCT03925129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-22

No results posted yet for this study

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

Interventions

DEVICE

high frequency TENS treatment

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

DEVICE

Sham TENS treatment

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

Sponsors & Collaborators

  • Planned Parenthood of Greater New York

    lead OTHER

Principal Investigators

  • Ariella Goldman, MD · Planned Parenthood of Greater New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2020-03-06
Completion
2020-03-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925129 on ClinicalTrials.gov