Abortion in First Trimester
Conditions
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.
Interventions
DEVICEhigh frequency TENS treatment
Treatment with high frequency for minimum of 1 hour after misoprostol administration
DEVICESham TENS treatment
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration
Sponsors
Planned Parenthood of Greater New York
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on numeric rating scale | 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. |
Countries
United States
Outcome results
None listed