Abortion; InducedSaLMANCT01356927
Same-day Long-acting Reversible Contraception for Medication Abortion
An observational study of Abortion; Induced, run by Boston University at 1 site in United States.
Trial summary
Contraception after abortion is an important public health issue, as women who have an abortion are at high risk for additional unintended pregnancy. In the context of first trimester medical abortion, the standard of care is to administer long-acting reversible contraception, including the etonogestrel implant… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abortion; Induced
- What is being tested?
- DMPA and Etonogestrel implant
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2014
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will be women who elect a medication abortion at Boston Medical Center and who desire either Implanon or DMPA. Those that appear to meet the eligibility and none of the exclusion criteria will be asked by their clinician if they are interested in participating in the observational study. Those interested will be contacted by the PI or PI's designated staff to discuss details about the study.
Who may be able to join
- Desiring and eligible for medication abortion
- Desiring and eligible for etonogestrel implant or DMPA
Who cannot join
- Contraindications to DMPA or etonogestrel implant per CDC guidelines regarding United States Medical Eligibility for Contraceptive Use (Centers for Disease Control, 2010)
- Contraindications to mifepristone and misoprostol including ectopic pregnancy, pregnancy with intrauterine device in place, chronic adrenal failure, significant anemia, bleeding disorder, chronic steroid use, inability to follow up, lack of emergency medical access, allergy to mifepristone or misoprostol, malignant liver tumor, benign hepatocellular adenoma, systemic lupus erythematosis with antiphospholipid antibody syndrome, active liver disease, or history of breast cancer or current breast cancer
- Nonworking telephone number (as assessed on initial visit)
- Unable to give informed consent, or unable to speak English, Spanish, or French Creole
- Unable to be contacted because of confidentiality issues
- Currently breastfeeding
- Intending to move away from the Boston area within one year
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion
Contraception after abortion is an important public health issue, as women who have an abortion are at high risk for additional unintended pregnancy. In the context of first trimester medical abortion, the standard of care is to administer long-acting reversible contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone acetate (DMPA), at a follow-up appointment after the abortion.
The investigators plan to conduct a prospective observational pilot study to evaluate the satisfaction of subjects who have selected either the contraceptive implant or DMPA given on the first day of medical abortion, as opposed to at a follow-up appointment. The investigators will also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12 months after the initial date of administration. In addition, the investigators will assess the total days of bleeding after the abortion, follow-up rate for evaluation of completion of medical abortion, and efficacy of medical abortion.
A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA. They will be asked to fill out questionnaires during the course of the study, and will be followed for one year. The study duration including data analysis will be two years.
Read the detailed description
This is a prospective, observational pilot study of administration of either Implanon or DMPA on the first day of medication abortion. Subjects in this two cohorts will be followed for one year, with questionnaires administered at intake, 2 weeks, 4 weeks, and 3, 6, 9, and 12 months after recruitment.
On the day of recruitment, after the patient has consented both to medication abortion and contraceptive method (Implanon or DMPA), the provider will ask the patient if they are interested in participation in the study. If the patient is interested, a research assistant or investigator will be called to discuss the study in private with the potential subject. Consent will be obtained by the investigator, and the intake questionnaire with baseline contraceptive and demographic data will be administered. Mifepristone for medication abortion will be administered per protocol by the provider, and then Implanon or DMPA will be administered. The clinician who provides the medication abortion will not be the same person as the investigator who is consenting for research. A bleeding diary card will be given to the subject to record daily bleeding. The subject will be requested to return this card by mail in 4 weeks, and will be given an addressed and stamped envelope.
Subjects will be scheduled for a 7-day follow-up appointment as per medication abortion protocol, and at that visit, a short questionnaire regarding the satisfaction with timing of contraceptive method, and number of days of bleeding will be administered. Subjects will then be contacted by their preferred modality (phone, email, or text message) at 2 weeks, to assess for total days of bleeding. If the subject is continuing to have bleeding, they will be contacted again at 4 weeks to assess for total days of bleeding. At each of these contact points, satisfaction with timing of placement, and satisfaction with contraceptive method will be assessed via a Likert scale. Additional contact will be made at 3, 6, 9, and 12 months for all subjects to assess continuation of the contraceptive method.
If unable to contact the subject or listed emergency contacts a total of five times by their preferred or alternate modalities of contact, a letter will be sent along with a self-addressed stamped envelope.
Outcomes (Indicate anticipated primary and any secondary outcomes and how they will be measured):
The primary study objectives are to assess the following:
- Subject satisfaction with timing of placement as determined by questionnaire
- Continuation of contraceptive method at 3, 6, 9, and 12 month as determined by questionnaire
The secondary study objectives are to assess the following:
- Total days of bleeding after the abortion
- Follow-up rate for evaluation of completion of medication abortion
- Failure rate of medication abortion
- The number of women screened for participation
- Reasons for refusal to participate in the study
- Reasons for ineligibility
- The number of women who change their contraceptive method during the year of follow-up.
- Conditions
- Abortion; Induced
- Being tested
- DMPA, Etonogestrel implant
- Keywords
- long acting reversible contraception, medical abortion, DMPA, etonogestrel implant, Implanon, contraceptive continuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMPADrug
Also called Depo Provera
DMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion
Etonogestrel implantDrug
Also called Implanon
Etonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion
| Study group | Role | What they receive |
|---|---|---|
| DMPA | DMPA given at the time of mifepristone for medical abortion Receives: Drug: DMPA | |
| Etonogestrel implant | Etonogestrel implant placed at the time of mifepristone for medical abortion Receives: Drug: Etonogestrel implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with timing of contraceptive administration
Measured: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
Continuation rate of contraceptive method
Measured: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
Secondary outcomes (4)
Number of days of bleeding
Measured: 28 days
Follow-up rate after abortion
Measured: 14 days
Failure of medical abortion
Measured: 7 days
Reasons for non-enrollment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abortion; InducedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Family Planning Fellowship
- Responsible party
- Sponsor
- Investigators
- Sarita Sonalkar, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356927
- Sponsor's protocol ID
- H-30255
- Acronym
- SaLMA
- Status last verified
- Apr 2017
- First submitted
- 18 May 2011
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonalkar S, McClusky J, Hou MY, Borgatta L. Administration of depot medroxyprogesterone acetate on the day of mifepristone for medical abortion: a pilot study. Contraception. 2015 Feb;91(2):174-7. doi: 10.1016/j.contraception.2014.10.010. Epub 2014 Nov 6.
PubMed 25481376Sonalkar S, Hou MY, Borgatta L. Administration of the etonogestrel contraceptive implant on the day of mifepristone for medical abortion: a pilot study. Contraception. 2013 Nov;88(5):671-3. doi: 10.1016/j.contraception.2013.07.008. Epub 2013 Jul 29.
PubMed 24028749
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion
- ClinicalTrials.gov ID
- NCT01356927
- Acronym / sponsor ID
- SaLMA / H-30255
- Conditions
- Abortion; Induced
- Keywords
- long acting reversible contraception, medical abortion, DMPA, etonogestrel implant, Implanon, contraceptive continuation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Family Planning Fellowship
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 May 2011 (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.
Contraception after abortion is an important public health issue, as women who have an abortion are at high risk for additional unintended pregnancy. In the context of first trimester medical abortion, the standard of care is to administer long-acting reversible contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone acetate (DMPA), at a follow-up appointment after the abortion.
The investigators plan to conduct a prospective observational pilot study to evaluate the satisfaction of subjects who have selected either the contraceptive implant or DMPA given on the first day of medical abortion, as opposed to at a follow-up appointment. The investigators will also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12 months after the initial date of administration. In addition, the investigators will assess the total days of bleeding after the abortion, follow-up rate for evaluation of completion of medical abortion, and efficacy of medical abortion.
A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA. They will be asked to fill out questionnaires during the course of the study, and will be followed for one year. The study duration including data analysis will be two years.
Detailed description
This is a prospective, observational pilot study of administration of either Implanon or DMPA on the first day of medication abortion. Subjects in this two cohorts will be followed for one year, with questionnaires administered at intake, 2 weeks, 4 weeks, and 3, 6, 9, and 12 months after recruitment.
On the day of recruitment, after the patient has consented both to medication abortion and contraceptive method (Implanon or DMPA), the provider will ask the patient if they are interested in participation in the study. If the patient is interested, a research assistant or investigator will be called to discuss the study in private with the potential subject. Consent will be obtained by the investigator, and the intake questionnaire with baseline contraceptive and demographic data will be administered. Mifepristone for medication abortion will be administered per protocol by the provider, and then Implanon or DMPA will be administered. The clinician who provides the medication abortion will not be the same person as the investigator who is consenting for research. A bleeding diary card will be given to the subject to record daily bleeding. The subject will be requested to return this card by mail in 4 weeks, and will be given an addressed and stamped envelope.
Subjects will be scheduled for a 7-day follow-up appointment as per medication abortion protocol, and at that visit, a short questionnaire regarding the satisfaction with timing of contraceptive method, and number of days of bleeding will be administered. Subjects will then be contacted by their preferred modality (phone, email, or text message) at 2 weeks, to assess for total days of bleeding. If the subject is continuing to have bleeding, they will be contacted again at 4 weeks to assess for total days of bleeding. At each of these contact points, satisfaction with timing of placement, and satisfaction with contraceptive method will be assessed via a Likert scale. Additional contact will be made at 3, 6, 9, and 12 months for all subjects to assess continuation of the contraceptive method.
If unable to contact the subject or listed emergency contacts a total of five times by their preferred or alternate modalities of contact, a letter will be sent along with a self-addressed stamped envelope.
Outcomes (Indicate anticipated primary and any secondary outcomes and how they will be measured):
The primary study objectives are to assess the following:
- Subject satisfaction with timing of placement as determined by questionnaire
- Continuation of contraceptive method at 3, 6, 9, and 12 month as determined by questionnaire
The secondary study objectives are to assess the following:
- Total days of bleeding after the abortion
- Follow-up rate for evaluation of completion of medication abortion
- Failure rate of medication abortion
- The number of women screened for participation
- Reasons for refusal to participate in the study
- Reasons for ineligibility
- The number of women who change their contraceptive method during the year of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMPA | – | Drug: DMPADMPA given at the time of mifepristone for medical abortion |
| Etonogestrel implant | – | Drug: Etonogestrel implantEtonogestrel implant placed at the time of mifepristone for medical abortion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be women who elect a medication abortion at Boston Medical Center and who desire either Implanon or DMPA. Those that appear to meet the eligibility and none of the exclusion criteria will be asked by their clinician if they are interested in participating in the observational study. Those interested will be contacted by the PI or PI's designated staff to discuss details about the study.
Key inclusion criteria (2 listed)
- Desiring and eligible for medication abortion
- Desiring and eligible for etonogestrel implant or DMPA
Key exclusion criteria (7 listed)
- Contraindications to DMPA or etonogestrel implant per CDC guidelines regarding United States Medical Eligibility for Contraceptive Use (Centers for Disease Control, 2010)
- Contraindications to mifepristone and misoprostol including ectopic pregnancy, pregnancy with intrauterine device in place, chronic adrenal failure, significant anemia, bleeding disorder, chronic steroid use, inability to follow up, lack of emergency medical access, allergy to mifepristone or misoprostol, malignant liver tumor, benign hepatocellular adenoma, systemic lupus erythematosis with antiphospholipid antibody syndrome, active liver disease, or history of breast cancer or current breast cancer
- Nonworking telephone number (as assessed on initial visit)
- Unable to give informed consent, or unable to speak English, Spanish, or French Creole
- Unable to be contacted because of confidentiality issues
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 |
|---|---|---|
| DMPAAlso: Depo ProveraDMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion | Drug | DMPA |
| Etonogestrel implantAlso: ImplanonEtonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion | Drug | Etonogestrel implant |
Primary outcome
Satisfaction with timing of contraceptive administration
Time frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
Continuation rate of contraceptive method
Time frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
4 secondary outcomes
Number of days of bleeding
Time frame: 28 days
Follow-up rate after abortion
Time frame: 14 days
Failure of medical abortion
Time frame: 7 days
Reasons for non-enrollment
Time frame: 1 year
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 7 Apr 2017.
- Derived from this study: PubMed 25481376Sonalkar S, McClusky J, Hou MY, Borgatta L. Administration of depot medroxyprogesterone acetate on the day of mifepristone for medical abortion: a pilot study. Contraception. 2015 Feb;91(2):174-7. doi: 10.1016/j.contraception.2014.10.010. Epub 2014 Nov 6.
- Derived from this study: PubMed 24028749Sonalkar S, Hou MY, Borgatta L. Administration of the etonogestrel contraceptive implant on the day of mifepristone for medical abortion: a pilot study. Contraception. 2013 Nov;88(5):671-3. doi: 10.1016/j.contraception.2013.07.008. Epub 2013 Jul 29.
- 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.
Sarita Sonalkar, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion; Induced, run by Boston University 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 2 inclusion and 7 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 7 Apr 2017. 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?
Satisfaction with timing of contraceptive administration (time frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months). The study lists 2 primary outcomes in all. 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 NCT01356927, which also lists 2 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 7 Apr 2017.