Medical AbortionNCT00907725
Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?
A study testing serum BhCG follow-up and ultrasonographic follow-up in people with Medical Abortion, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if BhCG testing to determine the completion of medical abortion simplifies the medical abortion protocol. Investigators hypothesize that women randomized to ultrasonographic determination of completion of medical abortion will have MORE follow-up visits/interventions beyond… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Medical Abortion
- What is being tested?
- serum BhCG follow-up and ultrasonographic follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2010
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women undergoing medical abortion
- Proficiency in English
- Working phone and willingness to be contacted by phone
- Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with chosen follow-up method
Who cannot join
- Concern for ectopic pregnancy or unable to document intrauterine pregnancy
- Clinical instability or signs of pelvic infection
- Medical conditions that contraindicate medical abortion
- Unwilling or unable to comply with study follow-up procedures
- Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g., situations of domestic violence)
- Inability to give informed consent
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
About this study
Official title: Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial
The purpose of this study is to evaluate if BhCG testing to determine the completion of medical abortion simplifies the medical abortion protocol. Investigators hypothesize that women randomized to ultrasonographic determination of completion of medical abortion will have MORE follow-up visits/interventions beyond standard protocol than those randomized to medical abortion follow-up with serum BhCG.
The investigators also hope to explore satisfaction with BhCG based follow-up among women seeking medical abortion. Investigators hypothesize that the majority of women who choose to follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.
- Conditions
- Medical Abortion
- Being tested
- serum BhCG follow-up, ultrasonographic follow-up
- Keywords
- medical abortion, serum BhCG follow-up, ultrasonographic follow-up, follow-up methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum BhCG follow-upOther
Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
ultrasonographic follow-upOther
Subjects in this arm will receive medical abortion follow-up by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | serum BhCG follow-up Receives: Other: serum BhCG follow-up |
| 2 | Other | ultrasonographic follow-up Receives: Other: ultrasonographic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw
Measured: 4 weeks
Secondary outcomes (1)
Patient satisfaction with follow-up method
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
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 Medical 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
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Planned Parenthood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907725
- Sponsor's protocol ID
- 2009p000363
- Status last verified
- May 2012
- First submitted
- 22 May 2009
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dayananda I, Maurer R, Fortin J, Goldberg AB. Medical abortion follow-up with serum human chorionic gonadotropin compared with ultrasonography: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):607-613. doi: 10.1097/AOG.0b013e3182839fda.
PubMed 23635625
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00907725
- Acronym / sponsor ID
- 2009p000363
- Conditions
- Medical Abortion
- Keywords
- medical abortion, serum BhCG follow-up, ultrasonographic follow-up, follow-up methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 May 2009 (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 this study is to evaluate if BhCG testing to determine the completion of medical abortion simplifies the medical abortion protocol. Investigators hypothesize that women randomized to ultrasonographic determination of completion of medical abortion will have MORE follow-up visits/interventions beyond standard protocol than those randomized to medical abortion follow-up with serum BhCG.
The investigators also hope to explore satisfaction with BhCG based follow-up among women seeking medical abortion. Investigators hypothesize that the majority of women who choose to follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: serum BhCG follow-upserum BhCG follow-up |
| 2 | Other | Other: ultrasonographic follow-upultrasonographic follow-up |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women undergoing medical abortion
- Proficiency in English
- Working phone and willingness to be contacted by phone
- Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with chosen follow-up method
Key exclusion criteria (7 listed)
- Concern for ectopic pregnancy or unable to document intrauterine pregnancy
- Clinical instability or signs of pelvic infection
- Medical conditions that contraindicate medical abortion
- Unwilling or unable to comply with study follow-up procedures
- Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g., situations of domestic violence)
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 |
|---|---|---|
| serum BhCG follow-upSubjects in this arm will receive medical abortion follow-up using BhCG blood draw | Other | 1 |
| ultrasonographic follow-upSubjects in this arm will receive medical abortion follow-up by ultrasound | Other | 2 |
Primary outcome
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw
Time frame: 4 weeks
1 secondary outcome
Patient satisfaction with follow-up method
Time frame: 4 weeks
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 10 May 2012.
- Derived from this study: PubMed 23635625Dayananda I, Maurer R, Fortin J, Goldberg AB. Medical abortion follow-up with serum human chorionic gonadotropin compared with ultrasonography: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):607-613. doi: 10.1097/AOG.0b013e3182839fda.
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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.
Principal Investigator principal investigator
Planned Parenthood
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum BhCG follow-up and ultrasonographic follow-up in people with Medical Abortion, run by Planned Parenthood League of Massachusetts 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 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 10 May 2012. 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?
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw (time frame: 4 weeks). 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 NCT00907725, 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 10 May 2012.