PregnancyNCT04599725
Feasibility of Telemedicine Medical Abortion
An observational study of Pregnancy, run by Gynuity Health Projects at 15 sites in United States.
Trial summary
This pilot study is designed to obtain data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail. Read more about this study
- Who is it for?
- Ages 10 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- medical abortion
- How many people
- 413 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Observational
- 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 10 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: People seeking abortion
Who may be able to join
- desires abortion
Who cannot join
- medically ineligible for procedure
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Planned Parenthood of the Rocky Mountains
Albuquerque, New Mexico, 80207
Carafem
Atlanta, Georgia, 30309
Maine Family Planning
Augusta, Maine, 04332
Planned Parenthood of Montana
Billings, Montana, 59102
Maine Family Planning
Boston, Massachusetts, 02134
Carafem
Chevy Chase, Maryland, 20815
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80207
The University of Hawaii Women's Options Centers
Honolulu, Hawaii, 96826
Emma Goldman Clinic
Iowa City, Iowa, 52245
Maine Family Planning
New York, New York, 04332
Planned Parenthood Columbia Willamette
Portland, Oregon, 97212
Planned Parenthood Minnesota, North Dakota, South Dakota
Saint Paul, Minnesota, 55114
Carafem
Skokie, Illinois, 60076
Planned Parenthood Columbia Willamette
Vancouver, Washington, 97212
Carafem
Washington D.C., District of Columbia, 20815
About this study
Official title: TelAbortion: Medical Abortion by Direct-to-patient Telemedicine and Mail
This pilot study is designed to obtain data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail.
- Conditions
- Pregnancy
- Being tested
- medical abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical abortionDrug
medical abortion
| Study group | Role | What they receive |
|---|---|---|
| Pregnant people | Not described Receives: Drug: medical abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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 PregnancyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Raymond, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599725
- Sponsor's protocol ID
- 1049
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Anger HA, Raymond EG. Clinical and service delivery outcomes following medication abortion provided with or without pretreatment ultrasound or pelvic examination: An updated comparative analysis. Contraception. 2024 Dec;140:110552. doi: 10.1016/j.contraception.2024.110552. Epub 2024 Jul 25.
PubMed 39059683
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TelAbortion: Medical Abortion by Direct-to-patient Telemedicine and Mail
- ClinicalTrials.gov ID
- NCT04599725
- Acronym / sponsor ID
- 1049
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 23 Oct 2020 (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 pilot study is designed to obtain data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant people | – | Drug: medical abortion |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- People seeking abortion
Key inclusion criteria (1 listed)
- desires abortion
Key exclusion criteria (1 listed)
- medically ineligible for procedure
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 |
|---|---|---|
| medical abortionmedical abortion | Drug | Pregnant people |
Primary outcome
Number of participants with adverse events
Time frame: 2 years
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 4 Feb 2022.
- Derived from this study: PubMed 39059683Anger HA, Raymond EG. Clinical and service delivery outcomes following medication abortion provided with or without pretreatment ultrasound or pelvic examination: An updated comparative analysis. Contraception. 2024 Dec;140:110552. doi: 10.1016/j.contraception.2024.110552. Epub 2024 Jul 25.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Elizabeth Raymond, MD, MPH principal investigator
Gynuity Health Projects
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Gynuity Health Projects at 15 sites 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 1 inclusion and 1 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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?
Number of participants with adverse events (time frame: 2 years). 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 NCT04599725, 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 4 Feb 2022.