AbortionSAMiNCT00986921

Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

A study testing mifepristone 200 mg and osmotic dilator insertion in people with Abortion, run by Boston University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Abortion
What is being tested?: mifepristone 200 mg and osmotic dilator insertion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Mar 2011
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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

women aged 18-45 having pregnancy termination at 14-16 weeks

Who cannot join

multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Medical Center
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Conditions: Abortion
Being tested: mifepristone 200 mg, osmotic dilator insertion
Keywords: Length of time for procedure to be completed, Need for additional dilation, Subject satisfaction with procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mifepristone 200 mgDrug
mifepristone would be given the day before the procedure
osmotic dilator insertionDevice
osmotic dilators (3-6) would be inserted as usual the day before the procedure

Study groups in NCT00986921
Study group	Role	What they receive
mifepristone	Experimental	women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed. Receives: Drug: mifepristone 200 mg
Osmotic dilator insertion	Active comparator	Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure Receives: Device: osmotic dilator insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

Time for Completion of Procedure
Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)
Measured: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.

Secondary outcomes (2)

Assessment of Ease of Procedure by Operator
The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult".
Measured: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.
Moderate or Severe Pain Overnight
Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)
Measured: Overnight

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Mar 2011

First posted30 Sep 2009 (estimated)
Study startOct 2009
Primary completionMar 2011
Study completionMar 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AbortionStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00986921
Sponsor's protocol ID: SAMi
Acronym: SAMi
Status last verified: Dec 2013
First submitted: 23 Sep 2009
Last updated: 31 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.
PubMed 22682721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Abortion trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
ClinicalTrials.gov ID: NCT00986921
Acronym / sponsor ID: SAMi / SAMi
Conditions: Abortion
Keywords: Length of time for procedure to be completed, Need for additional dilation, Subject satisfaction with procedure
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Boston UniversityUniversity, hospital or other
Collaborators: Society of Family Planning
Study start: Oct 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 30 Sep 2009 (estimated)
Results: Posted 2 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
mifepristone	Experimental	Drug: mifepristone 200 mgwomen in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.
Osmotic dilator insertion	Active comparator	Device: osmotic dilator insertionWomen assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

women aged 18-45 having pregnancy termination at 14-16 weeks

Key exclusion criteria (1 listed)

multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper 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
mifepristone 200 mgmifepristone would be given the day before the procedure	Drug	mifepristone
osmotic dilator insertionosmotic dilators (3-6) would be inserted as usual the day before the procedure	Device	Osmotic dilator insertion

Primary outcome

Time for Completion of Procedure
Time frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.
Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)

2 secondary outcomes

Assessment of Ease of Procedure by Operator
Time frame: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.
Moderate or Severe Pain Overnight
Time frame: Overnight

Results and safety

Results posted to the registry on 2 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Osmotic Dilator Insertion	25	24
Mifepristone	25	25

Primary outcome: Time for Completion of Procedure

Time frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.. Mean (95% Confidence Interval). Unit: Minutes

Measure	Standard Osmotic Dilators n = 24	Mifepristone n = 25
Value	8.0 (6.75 to 11.47)	9.87 (8.93 to 11.36)

Standard Osmotic Dilators vs Mifepristone: Mean Difference (Final Values): 1.87 (95% CI 0 to 3), p = 0.05, t-test, 1 sided

Population analysed: Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Osmotic Dilators	0 of 25 (0%)	0 of 25 (0%)	Not reported
Mifepristone	0 of 25 (0%)	0 of 25 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was completed as planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22682721Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.

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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.

L B, 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 mifepristone 200 mg and osmotic dilator insertion in people with Abortion, 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 1 inclusion and 1 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 31 Jan 2014. 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 2 Dec 2013). 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?

Time for Completion of Procedure (time frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.). 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 NCT00986921, 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 31 Jan 2014.