Cervical PreparationPhase 3SaMi2NCT01436279
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
A Phase 3 study testing Mifepristone and osmotic dilators in people with Cervical Preparation, run by Boston University at 1 site in United States.
Trial summary
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Preparation
- What is being tested?
- Mifepristone and osmotic dilators
- 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
- Jul 2011to Aug 2013
- Phase
- Phase 3
- 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
- Women 18-50 years of age undergoing surgical termination of pregnancy
- English or Spanish speaking
- Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
- Eligible for a dilation and evacuation abortion with local anesthesia and sedation
- Ultrasound for dating purposes done within the last two weeks
Who cannot join
- Intrauterine infection
- Fetal demise
- Ruptured membranes
- Multiple gestation
- Uterine anomaly or significant distortion of the uterus with fibroids
- BMI greater than 45
Show all 11Show fewer
- Inability to place osmotic dilators
- Active substance abuse or intoxication
- Adrenal failure, chronic corticosteroid use, anticoagulant usage
- Severe cervicitis, until treated and resolved
- Prior Cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
- Conditions
- Cervical Preparation
- Being tested
- Mifepristone, osmotic dilators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called Mifeprex, RU-486, Mifegyne
200 mg po 20-24 hours prior to the procedure
osmotic dilatorsDevice
Also called Laminaria, Dilapan-S, Dilapan
osmotic dilators placed in the cervix 20-24 hours prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone + misoprostol | Experimental | Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure Receives: Drug: Mifepristone |
| Osmotic dilators | Active comparator | Placed 20-24 hours prior to procedure Receives: Device: osmotic dilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Procedure
Interval from speculum insertion to speculum removal
Measured: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
Secondary outcomes (7)
Operative Time
Interval from initiation of vacuum aspiration to speculum removal
Measured: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Subject Discomfort Before the Abortion
Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe
Measured: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Pain Medication (Fentanyl) During the Abortion
Amount of pain medication used during the procedure: reported as micrograms of fentanyl
Measured: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Pain Medication (Midazolam) During the Abortion
Amount of pain medication used during the procedure: reported as milligrams of midazolam
Measured: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Cervical Dilation Achieved
Cervical dilation at start of procedure
Measured: At time of abortion
Acceptability to Patient
Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.
Measured: After procedure completion
Difficulty of Procedure
Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."
Measured: After completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2013
- Study completionAug 2013
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 Cervical PreparationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Sarita Sonalkar, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436279
- Sponsor's protocol ID
- H-31032
- Other IDs
- AU 6003109
- Acronym
- SaMi2
- Status last verified
- May 2017
- First submitted
- 15 Sep 2011
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
- ClinicalTrials.gov ID
- NCT01436279
- Acronym / sponsor ID
- SaMi2 / H-31032
- Conditions
- Cervical Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone + misoprostol | Experimental | Drug: MifepristoneMifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure |
| Osmotic dilators | Active comparator | Device: osmotic dilatorsPlaced 20-24 hours prior to procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 18-50 years of age undergoing surgical termination of pregnancy
- English or Spanish speaking
- Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
- Eligible for a dilation and evacuation abortion with local anesthesia and sedation
- Ultrasound for dating purposes done within the last two weeks
Key exclusion criteria (11 listed)
- Intrauterine infection
- Fetal demise
- Ruptured membranes
- Multiple gestation
- Uterine anomaly or significant distortion of the uterus with fibroids
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 |
|---|---|---|
| MifepristoneAlso: Mifeprex, RU-486, Mifegyne200 mg po 20-24 hours prior to the procedure | Drug | Mifepristone + misoprostol |
| osmotic dilatorsAlso: Laminaria, Dilapan-S, Dilapanosmotic dilators placed in the cervix 20-24 hours prior to the procedure | Device | Osmotic dilators |
Primary outcome
Length of Procedure
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
Interval from speculum insertion to speculum removal
7 secondary outcomes
Operative Time
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Subject Discomfort Before the Abortion
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Pain Medication (Fentanyl) During the Abortion
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Pain Medication (Midazolam) During the Abortion
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Cervical Dilation Achieved
Time frame: At time of abortion
Acceptability to Patient
Time frame: After procedure completion
Difficulty of Procedure
Time frame: After completion of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone and osmotic dilators in people with Cervical Preparation, 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 5 inclusion and 11 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 14 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). 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 Procedure (time frame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.). 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 14 Jun 2017.