Second Trimester AbortionPhase 2NCT03714880
Cervical Preparation With Mifepristone Prior to Osmotic Dilators
A Phase 2 study testing Mifepristone 200 MG in people with Second Trimester Abortion, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Trimester Abortion
- What is being tested?
- Mifepristone 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 26 Feb 2021
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol
Who cannot join
- Allergy or known intolerance to mifepristone
- Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:
- Chronic adrenal failure or insufficiency
- Concurrent use of long-term corticosteroid therapy
- Inherited porphyrias
- Any condition that in the opinion of the investigator could impede study participation or collection of study data
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Obstetrics and Gynecology
Sacramento, California, 95817
About this study
Official title: Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures.
Read the detailed description
No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D\&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.
- Conditions
- Second Trimester Abortion
- Being tested
- Mifepristone 200 MG, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone 200 MGDrug
Ingestion of study medication vs placebo
Placebo Oral TabletDrug
Ingestion of study medication vs placebo
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Receives: Drug: Mifepristone 200 MG |
| Placebo | Placebo comparator | Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Had Placement of Expected Dilators or More
The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more."
Measured: At time of 1 hour clinic visit (10 minutes)
Secondary outcomes (6)
Cervical Dilation
Measurement of cervical dilation at time of procedure
Measured: At time of ~1 hour scheduled procedure time (1 minute)
Number of Participants That Required Mechanical Dilation
A count of the number of participants that required of mechanical dilation at time of procedure
Measured: At time of ~1 hour scheduled procedure time (10 minute)
Pain Dilator Placement Using Visual Analog Scale
Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of "no pain" at 0 cm and "worst pain in your life" at 10 cm.
Higher scores indicate worse outcome.
Measured: At time of 1 hour clinic visit (10 minutes)
Provider Assessment of Procedure as "Very Easy" or "Easy"
Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as "Very Easy" or "Easy" (Survey response based on Likert scale: "Very Easy," "Easy," "Moderate," "Difficult," "Very Difficult")
Measured: At time of ~1 hour scheduled procedure time
Number of Participants That Experienced Complications
Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries
Measured: At time of ~1 hour scheduled procedure time (0-30 minute)
Number of Participants That Required Mechanical Dilation
Number of participants that required mechanical dilation at time of procedure
Measured: At time of ~1 hour scheduled procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start26 Apr 2019
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Why it stopped: Slow recruitment compounded by COVID-19
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 Second Trimester AbortionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714880
- Sponsor's protocol ID
- 1317056
- Status last verified
- Jun 2022
- First submitted
- 17 Oct 2018
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03714880
- Acronym / sponsor ID
- 1317056
- Conditions
- Second Trimester Abortion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment compounded by COVID-19
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 8 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures.
Detailed description
No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D\&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: Mifepristone 200 MGParticipants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletParticipants ingest placebo oral medication once 18-24 hours prior to dilator placement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol
Key exclusion criteria (6 listed)
- Allergy or known intolerance to mifepristone
- Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:
- Chronic adrenal failure or insufficiency
- Concurrent use of long-term corticosteroid therapy
- Inherited porphyrias
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 MGIngestion of study medication vs placebo | Drug | Mifepristone |
| Placebo Oral TabletIngestion of study medication vs placebo | Drug | Placebo |
Primary outcome
Number of Participants That Had Placement of Expected Dilators or More
Time frame: At time of 1 hour clinic visit (10 minutes)
The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more."
6 secondary outcomes
Cervical Dilation
Time frame: At time of ~1 hour scheduled procedure time (1 minute)
Number of Participants That Required Mechanical Dilation
Time frame: At time of ~1 hour scheduled procedure time (10 minute)
Pain Dilator Placement Using Visual Analog Scale
Time frame: At time of 1 hour clinic visit (10 minutes)
Provider Assessment of Procedure as "Very Easy" or "Easy"
Time frame: At time of ~1 hour scheduled procedure time
Number of Participants That Experienced Complications
Time frame: At time of ~1 hour scheduled procedure time (0-30 minute)
Number of Participants That Required Mechanical Dilation
Time frame: At time of ~1 hour scheduled procedure time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Second Trimester Abortion
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 4
Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Abortion, Dilation and Evacuation
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone 200 MG in people with Second Trimester Abortion, run by University of California, Davis 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 6 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 Jun 2022. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Jun 2022). 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?
Number of Participants That Had Placement of Expected Dilators or More (time frame: At time of 1 hour clinic visit (10 minutes)). 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 Jun 2022.