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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS | Experimental |
| |
| Sham TENS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high frequency TENS treatment | Device | Treatment with high frequency for minimum of 1 hour after misoprostol administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariella Goldman, MD | Planned Parenthood of Greater New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of New York City - Margaret Sanger Center | New York | New York | 10012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278292 | Derived | 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. |
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| Sham TENS treatment | Device | Treatment with sham TENS device for minimum of 1 hour after misoprostol administration |
|