Abortion, InducedDAISNCT00855842
Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
A study testing osmotic dilator insertion in people with Abortion, Induced, run by Boston University at 1 site in United States.
Trial summary
One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled) Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- osmotic dilator insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2010
- Phase
- Interventional
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Requesting abortion 19-23 weeks
- No contraindication to induction abortion
Who cannot join
- Fetal demise
- Ruptured membranes
- Evidence of pelvic infection
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)
Read the detailed description
This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.
- Conditions
- Abortion, Induced
- Being tested
- osmotic dilator insertion
- Keywords
- second trimester abortion, labor induction abortion, second trimester medical abortion, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osmotic dilator insertionDevice
Also called laminaria, Dilapan
osmotic dilators are placed in the cervix to cause cervical dilation
| Study group | Role | What they receive |
|---|---|---|
| osmotic dilator | Experimental | osmotic dilator Receives: Device: osmotic dilator insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Medical Abortion
This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus
Measured: hours since the start of medical abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: inadequate enrollment
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 Abortion, InducedStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Investigators
- Lynn Borgatta, MD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855842
- Sponsor's protocol ID
- DAIS
- Acronym
- DAIS
- Status last verified
- Jun 2011
- First submitted
- 2 Mar 2009
- Last updated
- 8 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
- ClinicalTrials.gov ID
- NCT00855842
- Acronym / sponsor ID
- DAIS / DAIS
- Conditions
- Abortion, Induced
- Keywords
- second trimester abortion, labor induction abortion, second trimester medical abortion, pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Posted 8 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)
Detailed description
This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osmotic dilator | Experimental | Device: osmotic dilator insertionosmotic dilator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Requesting abortion 19-23 weeks
- No contraindication to induction abortion
Key exclusion criteria (4 listed)
- Fetal demise
- Ruptured membranes
- Evidence of pelvic infection
- Inability to give informed consent
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 |
|---|---|---|
| osmotic dilator insertionAlso: laminaria, Dilapanosmotic dilators are placed in the cervix to cause cervical dilation | Device | osmotic dilator |
Primary outcome
Length of Medical Abortion
Time frame: hours since the start of medical abortion
This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- 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.
Lynn Borgatta, MD, MPH 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?
A study testing osmotic dilator insertion in people with 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 4 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: stopped early, as of the sponsor's last update on 8 Jul 2011. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2011). 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?
Length of Medical Abortion (time frame: hours since the start of medical abortion). 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 8 Jul 2011.