Abortion, InducedNCT01615731
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
A study testing Mifepristone, Hygroscopic cervical dilators and Misoprostol in people with Abortion, Induced, run by Stanford University at 2 sites in United States.
Trial summary
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- Mifepristone, Hygroscopic cervical dilators and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jul 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Who cannot join
- Allergy to misoprostol or mifepristone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Santa Clara Valley Medical Center
San Jose, California, 95128
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
- Conditions
- Abortion, Induced
- Being tested
- Mifepristone, Hygroscopic cervical dilators, Misoprostol, Intra-amniotic digoxin
- Keywords
- Mifepristone, Induced Abortion, Dilation and Evacuation, Cervical preparation, Osmotic dilators
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called Danco, Mifeprex
200mg Mifepristone orally
Hygroscopic cervical dilatorsOther
Also called Dilapan-S
Dilapan-S osmostic cervical dilators inserted through the internal os
MisoprostolDrug
400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxinDrug
1mg digoxin administered intra-amniotically ~24 hours pre-op
| Study group | Role | What they receive |
|---|---|---|
| Two sets of dilators | Active comparator | Two sets of osmotic dilators inserted 1 and 2 days pre-op Receives: Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin |
| Mifepristone plus one set of dilators | Experimental | One set of dilators plus mifepristone Receives: Drug: Mifepristone; Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time
Measured as time from speculum insertion to removal
Measured: Intraoperative Time
Total Procedure Time
Measured: Measured at clinic visits and on OR day, over a 3 day period
Secondary outcomes (6)
Maximum Cervical Dilation
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Measured: Measured intra-operatively
Adverse Events (EBL)
One adverse event: Estimated Blood Loss
Measured: Intraoperatively
Ease of Procedure by Blinded Surgeon
Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
Measured: Measured Immediately after procedure
Pain Perceived by Patient
Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
Measured: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
Overall Patient Experience
Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
Measured: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
Adverse Events
uterine perforation, uterine injury, etc.
Measured: Intraoperatively and 2 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJul 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 Abortion, InducedStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615731
- Sponsor's protocol ID
- SU-05302012-10088
- Status last verified
- Jan 2024
- First submitted
- 30 May 2012
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01615731
- Acronym / sponsor ID
- SU-05302012-10088
- Conditions
- Abortion, Induced
- Keywords
- Mifepristone, Induced Abortion, Dilation and Evacuation, Cervical preparation, Osmotic dilators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two sets of dilators | Active comparator | Other: Hygroscopic cervical dilators, Drug: Misoprostol, Drug: Intra-amniotic digoxinTwo sets of osmotic dilators inserted 1 and 2 days pre-op |
| Mifepristone plus one set of dilators | Experimental | Drug: Mifepristone, Other: Hygroscopic cervical dilators, Drug: Misoprostol, Drug: Intra-amniotic digoxinOne set of dilators plus mifepristone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Key exclusion criteria (1 listed)
- Allergy to misoprostol or mifepristone
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: Danco, Mifeprex200mg Mifepristone orally | Drug | Mifepristone plus one set of dilators |
| Hygroscopic cervical dilatorsAlso: Dilapan-SDilapan-S osmostic cervical dilators inserted through the internal os | Other | Mifepristone plus one set of dilators, Two sets of dilators |
| Misoprostol400mcg buccal misoprostol 90 minutes pre-op | Drug | Mifepristone plus one set of dilators, Two sets of dilators |
| Intra-amniotic digoxin1mg digoxin administered intra-amniotically ~24 hours pre-op | Drug | Mifepristone plus one set of dilators, Two sets of dilators |
Primary outcome
Procedure Time
Time frame: Intraoperative Time
Measured as time from speculum insertion to removal
Total Procedure Time
Time frame: Measured at clinic visits and on OR day, over a 3 day period
6 secondary outcomes
Maximum Cervical Dilation
Time frame: Measured intra-operatively
Adverse Events (EBL)
Time frame: Intraoperatively
Ease of Procedure by Blinded Surgeon
Time frame: Measured Immediately after procedure
Pain Perceived by Patient
Time frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
Overall Patient Experience
Time frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
Adverse Events
Time frame: Intraoperatively and 2 weeks post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone, Hygroscopic cervical dilators and Misoprostol in people with Abortion, Induced, run by Stanford University at 2 sites 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 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 26 Jan 2015). 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?
Procedure Time (time frame: Intraoperative Time). 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?
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 13 Feb 2024.