Legally Induced Abortion Without Mention of ComplicationNCT02679092
Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
A study testing Misoprostol, Mifepristone and Hygroscopic cervical dilators in people with Legally Induced Abortion Without Mention of Complication, run by Stanford University at 1 site in United States.
Trial summary
Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Legally Induced Abortion Without Mention of Complication
- What is being tested?
- Misoprostol, Mifepristone and Hygroscopic cervical dilators
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2020
- 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 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 14-19 weeks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Who cannot join
- Allergy to study drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Mar Monte
San Jose, California, 95126
About this study
Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\&E.
- Being tested
- Misoprostol, Mifepristone, Hygroscopic cervical dilators
- Keywords
- Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators, Misoprostol
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
400 mcg buccal 60-90 minutes prior to procedure
MifepristoneDrug
Also called Danco, Mifeprex
200 mg PO on the day prior to D\&E
Hygroscopic cervical dilatorsDevice
Also called Dilapan-S
osmotic cervical dilators inserted through the internal os
| Study group | Role | What they receive |
|---|---|---|
| Dilapan (14wks 0days-15wks, 6days) | Active comparator | The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure. Receives: Device: Hygroscopic cervical dilators |
| Dilapan (16wks 0days-18wks, 6days) | Active comparator | The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Receives: Drug: Misoprostol; Device: Hygroscopic cervical dilators |
| Mifepristone (14wks 0days-15wks, 6days) | Experimental | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Receives: Drug: Misoprostol; Drug: Mifepristone |
| Mifepristone (16wks 0days-18wks, 6days) | Experimental | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Receives: Drug: Misoprostol; Drug: Mifepristone |
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
Secondary outcomes (6)
Cervical Dilation
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure
Measured: Baseline
Total Procedure Time
All time required by patient (time in clinic for cervical preparation procedures)
Measured: Measured at clinic visit and on OR day, over 2 day period
Difficulty of Procedure, as reported by clinician
Using Visual Analogue Scale (VAS)
Measured: Measured within 5 minutes after procedure
Complications/Adverse Events
Estimated blood loss, uterine injury, infection, retained products of conception
Measured: Intraoperatively
Pain Perceived by Patient
Using Visual Analogue Scale (VAS)
Measured: Intraoperatively "Measured during dilator placement"
Overall Patient Experience
Using Visual Analogue Scale (VAS)
Measured: Measured post-operatively (30 minutes prior to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startApr 2016 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Funding changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legally Induced Abortion Without Mention of ComplicationStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679092
- Sponsor's protocol ID
- IRB-36302
- Status last verified
- Sep 2019
- First submitted
- 3 Feb 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
- ClinicalTrials.gov ID
- NCT02679092
- Acronym / sponsor ID
- IRB-36302
- Keywords
- Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators, Misoprostol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding changes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2016 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Feb 2016 (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.
Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\&E.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dilapan (14wks 0days-15wks, 6days) | Active comparator | Device: Hygroscopic cervical dilatorsThe clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure. |
| Dilapan (16wks 0days-18wks, 6days) | Active comparator | Drug: Misoprostol, Device: Hygroscopic cervical dilatorsThe clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. |
| Mifepristone (14wks 0days-15wks, 6days) | Experimental | Drug: Misoprostol, Drug: MifepristoneThe patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. |
| Mifepristone (16wks 0days-18wks, 6days) | Experimental | Drug: Misoprostol, Drug: MifepristoneThe patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. |
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 14-19 weeks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Key exclusion criteria (1 listed)
- Allergy to study drugs
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 |
|---|---|---|
| MisoprostolAlso: Cytotec400 mcg buccal 60-90 minutes prior to procedure | Drug | Dilapan (16wks 0days-18wks, 6days), Mifepristone (14wks 0days-15wks, 6days), Mifepristone (16wks 0days-18wks, 6days) |
| MifepristoneAlso: Danco, Mifeprex200 mg PO on the day prior to D\&E | Drug | Mifepristone (14wks 0days-15wks, 6days), Mifepristone (16wks 0days-18wks, 6days) |
| Hygroscopic cervical dilatorsAlso: Dilapan-Sosmotic cervical dilators inserted through the internal os | Device | Dilapan (14wks 0days-15wks, 6days), Dilapan (16wks 0days-18wks, 6days) |
Primary outcome
Procedure Time
Time frame: Intraoperative
Measured as time from speculum insertion to removal.
6 secondary outcomes
Cervical Dilation
Time frame: Baseline
Total Procedure Time
Time frame: Measured at clinic visit and on OR day, over 2 day period
Difficulty of Procedure, as reported by clinician
Time frame: Measured within 5 minutes after procedure
Complications/Adverse Events
Time frame: Intraoperatively
Pain Perceived by Patient
Time frame: Intraoperatively "Measured during dilator placement"
Overall Patient Experience
Time frame: Measured post-operatively (30 minutes prior to discharge)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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
Stanford 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 Misoprostol, Mifepristone and Hygroscopic cervical dilators in people with Legally Induced Abortion Without Mention of Complication, run by Stanford 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 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: withdrawn, as of the sponsor's last update on 19 Sep 2019. 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 was withdrawn before enrolling participants, so there are no results.
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). 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 19 Sep 2019.