Abortion in First TrimesterNCT03925129
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
A study testing high frequency TENS treatment in people with Abortion in First Trimester, run by Planned Parenthood of Greater New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- high frequency TENS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Any opioid use during previous 30 days
- Current or prior use of TENS
- BMI > 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood of New York City - Margaret Sanger Center
New York, New York, 10012
About this study
Official title: A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
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
- Being tested
- high frequency TENS treatment, Sham TENS treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency TENS treatmentDevice
Treatment with high frequency for minimum of 1 hour after misoprostol administration
Sham TENS treatmentDevice
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Not described Receives: Device: high frequency TENS treatment |
| Sham TENS | Sham comparator | Not described Receives: Device: Sham TENS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours following misoprostol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start11 Jun 2019
- Primary completion6 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood of Greater New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariella Goldman, MD, Principal investigator, Planned Parenthood of Greater New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925129
- Sponsor's protocol ID
- TENS MAB
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33278292
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
- ClinicalTrials.gov ID
- NCT03925129
- Acronym / sponsor ID
- TENS MAB
- Conditions
- Abortion in First Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Planned Parenthood of Greater New YorkUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: high frequency TENS treatment |
| Sham TENS | Sham comparator | Device: Sham TENS treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high frequency TENS treatmentTreatment with high frequency for minimum of 1 hour after misoprostol administration | Device | TENS |
| Sham TENS treatmentTreatment with sham TENS device for minimum of 1 hour after misoprostol administration | Device | Sham TENS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 33278292Goldman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariella Goldman, MD principal investigator
Planned Parenthood of Greater New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency TENS treatment in people with Abortion in First Trimester, run by Planned Parenthood of Greater New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on numeric rating scale (time frame: 8 hours following misoprostol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.