Induced AbortionNCT01047748
A Trial of Digoxin Before Second-Trimester Abortion
A study testing intra-fetal digoxin injection and intra-amniotic digoxin injection in people with Induced Abortion, run by White, Katharine O'Connell, M.D., M.P.H. at 1 site in United States.
Trial summary
The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Induced Abortion
- What is being tested?
- intra-fetal digoxin injection and intra-amniotic digoxin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2013
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- at least 18 years old
- English or Spanish speaking
- be able to give informed consent
- documented fetal cardiac activity.
Who cannot join
- significant medical illness or cardiovascular disease
- current use of cardiac or antihypertensive medications
- cardiac arrhythmia on preoperative EKG
- multiple gestation
- morbid obesity (BMI greater than 40)
- known digoxin allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Los Angeles - Bixby Health Center
Los Angeles, California, 90033
About this study
Official title: A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination
The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.
Read the detailed description
Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the second trimester of pregnancy. The preferred technique for second-trimester pregnancy termination is dilation and evacuation, or D\&E. In 2006, 144,000 D\&Es were performed in the U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal injection of digoxin. Prior to D\&E, providers use digoxin to induce fetal death 1) for providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients who express a desire for fetal death prior to the abortion.
The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no evidence-based standards for how to best achieve fetal asystole prior to D\&E. Digoxin has been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days before the D\&E. Only one study has assessed the effectiveness of digoxin at varying dosages ; this was a retrospective and nonrandomized analysis. Published failure rates are based on small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be more effective, but is a technically more difficult procedure than intra-amniotic injection. The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of this study is to determine the optimum route for digoxin injection (intrafetal or intra-amniotic) that will maximize patient safety while maintaining effectiveness.
- Conditions
- Induced Abortion
- Being tested
- intra-fetal digoxin injection, intra-amniotic digoxin injection
- Keywords
- abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-fetal digoxin injectionDrug
Also called Lanoxin
Single transabdominal injection of digoxin 1 mg into the fetus
intra-amniotic digoxin injectionDrug
Also called Lanoxin
Single transabdominal injection of digoxin 1 mg into the amniotic fluid
| Study group | Role | What they receive |
|---|---|---|
| intra-fetal injection | Active comparator | Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion Receives: Drug: intra-fetal digoxin injection |
| intra-amniotic injection | Active comparator | Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion Receives: Drug: intra-amniotic digoxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in fetal asystole rates between groups
Measured: one day
Secondary outcomes (4)
digoxin-related side effects
Measured: one day
differences in surgical procedure between groups
Measured: one day
subject satisfaction
Measured: one day
serum digoxin levels in study subgroup
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Induced AbortionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- White, Katharine O'Connell, M.D., M.P.H.
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Katharine O White, MD, MPH, Principal investigator, Physicians for Reproductive Choice and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047748
- Sponsor's protocol ID
- 20082058
- Status last verified
- Apr 2013
- First submitted
- 11 Jan 2010
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson RA, Teplin VL, Drey EA, Thomas LJ, Darney PD. Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial. Obstet Gynecol. 2001 Mar;97(3):471-6. doi: 10.1016/s0029-7844(00)01148-0.
PubMed 11239659Molaei M, Jones HE, Weiselberg T, McManama M, Bassell J, Westhoff CL. Effectiveness and safety of digoxin to induce fetal demise prior to second-trimester abortion. Contraception. 2008 Mar;77(3):223-5. doi: 10.1016/j.contraception.2007.10.011. Epub 2008 Jan 22.
PubMed 18279695Drey EA, Thomas LJ, Benowitz NL, Goldschlager N, Darney PD. Safety of intra-amniotic digoxin administration before late second-trimester abortion by dilation and evacuation. Am J Obstet Gynecol. 2000 May;182(5):1063-6. doi: 10.1067/mob.2000.105438.
PubMed 10819828White KO, Nucatola DL, Westhoff C. Intra-fetal Compared With Intra-amniotic Digoxin Before Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1071-1076. doi: 10.1097/AOG.0000000000001671.
PubMed 27741192
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination
- ClinicalTrials.gov ID
- NCT01047748
- Acronym / sponsor ID
- 20082058
- Conditions
- Induced Abortion
- Keywords
- abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- White, Katharine O'Connell, M.D., M.P.H.
- Collaborators
- Society of Family Planning
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Jan 2010 (estimated)
- 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.
The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.
Detailed description
Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the second trimester of pregnancy. The preferred technique for second-trimester pregnancy termination is dilation and evacuation, or D\&E. In 2006, 144,000 D\&Es were performed in the U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal injection of digoxin. Prior to D\&E, providers use digoxin to induce fetal death 1) for providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients who express a desire for fetal death prior to the abortion.
The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no evidence-based standards for how to best achieve fetal asystole prior to D\&E. Digoxin has been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days before the D\&E. Only one study has assessed the effectiveness of digoxin at varying dosages ; this was a retrospective and nonrandomized analysis. Published failure rates are based on small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be more effective, but is a technically more difficult procedure than intra-amniotic injection. The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of this study is to determine the optimum route for digoxin injection (intrafetal or intra-amniotic) that will maximize patient safety while maintaining effectiveness.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-fetal injection | Active comparator | Drug: intra-fetal digoxin injectionSubjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion |
| intra-amniotic injection | Active comparator | Drug: intra-amniotic digoxin injectionSubjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- at least 18 years old
- English or Spanish speaking
- be able to give informed consent
- documented fetal cardiac activity.
Key exclusion criteria (6 listed)
- significant medical illness or cardiovascular disease
- current use of cardiac or antihypertensive medications
- cardiac arrhythmia on preoperative EKG
- multiple gestation
- morbid obesity (BMI greater than 40)
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 |
|---|---|---|
| intra-fetal digoxin injectionAlso: LanoxinSingle transabdominal injection of digoxin 1 mg into the fetus | Drug | intra-fetal injection |
| intra-amniotic digoxin injectionAlso: LanoxinSingle transabdominal injection of digoxin 1 mg into the amniotic fluid | Drug | intra-amniotic injection |
Primary outcome
difference in fetal asystole rates between groups
Time frame: one day
4 secondary outcomes
digoxin-related side effects
Time frame: one day
differences in surgical procedure between groups
Time frame: one day
subject satisfaction
Time frame: one day
serum digoxin levels in study subgroup
Time frame: one day
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 1 May 2013.
- Background: PubMed 11239659Jackson RA, Teplin VL, Drey EA, Thomas LJ, Darney PD. Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial. Obstet Gynecol. 2001 Mar;97(3):471-6. doi: 10.1016/s0029-7844(00)01148-0.
- Background: PubMed 18279695Molaei M, Jones HE, Weiselberg T, McManama M, Bassell J, Westhoff CL. Effectiveness and safety of digoxin to induce fetal demise prior to second-trimester abortion. Contraception. 2008 Mar;77(3):223-5. doi: 10.1016/j.contraception.2007.10.011. Epub 2008 Jan 22.
- Background: PubMed 10819828Drey EA, Thomas LJ, Benowitz NL, Goldschlager N, Darney PD. Safety of intra-amniotic digoxin administration before late second-trimester abortion by dilation and evacuation. Am J Obstet Gynecol. 2000 May;182(5):1063-6. doi: 10.1067/mob.2000.105438.
- Derived from this study: PubMed 27741192White KO, Nucatola DL, Westhoff C. Intra-fetal Compared With Intra-amniotic Digoxin Before Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1071-1076. doi: 10.1097/AOG.0000000000001671.
Related trials for Induced Abortion
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain, Anxiety
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
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.
Katharine O White, MD, MPH principal investigator
Physicians for Reproductive Choice and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-fetal digoxin injection and intra-amniotic digoxin injection in people with Induced Abortion, run by White, Katharine O'Connell, M.D., M.P.H. 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 4 inclusion and 6 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 1 May 2013. 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. 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?
difference in fetal asystole rates between groups (time frame: one day). 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 NCT01047748, which also lists 4 linked publications.
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 1 May 2013.