AbortionPhase 4NCT03136068
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
A Phase 4 study testing Digoxin in people with Abortion, run by University of California, San Francisco at 3 sites in United States.
Trial summary
This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns… 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
- What is being tested?
- Digoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Feb 2017to 31 May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 20 weeks 0 days-24 weeks 0 days gestation
- English or Spanish speaking
- 18 years or older
Who cannot join
- Under 18
- Contraindications to digoxin
Trial locations and contacts
3 sites in 1 country.
United States3 sites
FPA Women's Health
Long Beach, California, 90806
Lovejoy Surgicenter
Portland, Oregon, 97210
SFGH Women's Options Center
San Francisco, California, 94110
About this study
Official title: Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial
This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D\&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D\&E procedure, but doctors want to clarify how digoxin effects D\&E procedure time, if at all.
- Conditions
- Abortion
- Being tested
- Digoxin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
Trans-abdominal injection
PlaceboDrug
Trans-abdominal injection
| Study group | Role | What they receive |
|---|---|---|
| Digoxin | Experimental | Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Receives: Drug: Digoxin |
| Placebo | Placebo comparator | Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Duration
First instrument into uterus until procedure complete
Measured: Beginning to end of procedure (between 5 minutes and 1 hour)
Secondary outcomes (4)
Total Procedure Duration
Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything
Measured: done on Day 2 during the procedure
Measured Blood Loss
measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood
Measured: Day 2, during the procedure
Number of Patients With Reported Fetal Death Prior to Procedure
number of patients who had fetal death measured by ultrasound
Measured: Day 2, before procedure
Complications
hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start23 Feb 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- FPA Women's Health, Society of Family Planning, Oregon Health and Science University
- Responsible party
- Principal investigator, Jennifer Kerns, MD, MS, MPH, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136068
- Sponsor's protocol ID
- Digoxin RCT
- Status last verified
- Oct 2019
- First submitted
- 6 Feb 2017
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03136068
- Acronym / sponsor ID
- Digoxin RCT
- Conditions
- Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- FPA Women's Health, Society of Family Planning, Oregon Health and Science University
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 30 Oct 2019
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 research study to measure the effect of digoxin injection on Dilation and Evacuation (D\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D\&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D\&E procedure, but doctors want to clarify how digoxin effects D\&E procedure time, if at all.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digoxin | Experimental | Drug: DigoxinSubjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance |
| Placebo | Placebo comparator | Drug: PlaceboSubjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 weeks 0 days-24 weeks 0 days gestation
- English or Spanish speaking
- 18 years or older
Key exclusion criteria (2 listed)
- Under 18
- Contraindications to digoxin
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 |
|---|---|---|
| DigoxinTrans-abdominal injection | Drug | Digoxin |
| PlaceboTrans-abdominal injection | Drug | Placebo |
Primary outcome
Procedure Duration
Time frame: Beginning to end of procedure (between 5 minutes and 1 hour)
First instrument into uterus until procedure complete
4 secondary outcomes
Total Procedure Duration
Time frame: done on Day 2 during the procedure
Measured Blood Loss
Time frame: Day 2, during the procedure
Number of Patients With Reported Fetal Death Prior to Procedure
Time frame: Day 2, before procedure
Complications
Time frame: Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Digoxin in people with Abortion, run by University of California, San Francisco at 3 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 3 inclusion and 2 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procedure Duration (time frame: Beginning to end of procedure (between 5 minutes and 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.