Termination of PregnancyEarly Phase 1U-PrepNCT03802149
Ulipristal Acetate for Cervical Preparation
A Early Phase 1 study testing Ulipristal Acetate in people with Termination of Pregnancy, run by Stanford University at 1 site in United States.
Trial summary
This is a prospective cohort study exploring a broadened use of ulipristal acetate as a cervical preparation agent for second trimester surgical abortion. Specifically, this pilot study will test the feasibility of using ulipristal as a pharmacologic cervical preparation with adjunct misoprostol prior to surgical… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Termination of Pregnancy
- What is being tested?
- Ulipristal Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 2 Apr 2020
- Phase
- Early Phase 1
- 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
- Female, aged 18 years or older
- Singleton, viable intrauterine pregnancy between 16 to 18 6/7 weeks of gestation (by ultrasound dating performed prior to or same day of enrollment visit)
- Consented for an induced, elective abortion
- English-speaking
- Able to consent for research project
- Willingness to comply with study procedures
Who cannot join
- Inability to give informed consent
- Contraindications to surgical abortion under moderate sedation
- Allergy or previous unacceptable side effect from study medications
- Multiple gestation
- Intrauterine fetal demise or spontaneous abortion
- Rupture of membranes
Show all 16Show fewer
- Current cervical insufficiency
- History of liver disease
- Taken a CYP3A4 inhibitor within 5 elimination half-lives of the drug from the procedure
- Pre-dosing abnormal liver function tests
- Patients at increased risk of hepatitis based on a history of any of the following:
- Any history of underlying liver disorder, including hepatitis
- A family history of hepatitis or currently living with a person who has been given a diagnosis of hepatitis
- A history of or currently working as a sex worker
- A history of or currently using IV drugs
- A self-reported history of alcoholic dependency or abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion
This is a prospective cohort study exploring a broadened use of ulipristal acetate as a cervical preparation agent for second trimester surgical abortion. Specifically, this pilot study will test the feasibility of using ulipristal as a pharmacologic cervical preparation with adjunct misoprostol prior to surgical abortion.
Read the detailed description
Second trimester abortion comprises <10% of all induced abortions in the United States but there is still an important need to provide this service to women. Prior to dilation and evacuation (D\&E), adequate preparation of the uterine cervix is an important part of preventing complications of the procedure. Commonly, this is done using osmotic dilators that are placed into the uterine cervix but cervical preparation can also be achieved using medications alone. Mifepristone is commonly used for this purpose but its use is regulated and often restricted due to the REMS (Risk Evaluation and Mitigation Strategy) program. The objective of this pilot study is to test the feasibility of using ulipristal, an oral medication similar to Mifepristone, as a medical form of cervical preparation prior to surgical abortion.This is a prospective cohort study investigating the use of ulipristal acetate (UPA) for pharmacologic cervical preparation with adjunct misoprostol prior to second trimester surgical abortion among women who are 16 to 18 6/7 weeks gestational age. Due the mechanism of action of UPA as a selective progesterone receptor modulator (SPRM) being similar to that of mifepristone, a medication known to be effective for cervical preparation, the investigators seek to describe the use of another SPRM for this same purpose. The investigators will conduct a pilot study assessing the feasibility of using UPA for cervical priming and report descriptive measures of its use. Per clinic protocols, patients over 16-weeks gestation attend a consult and cervical preparation appointment the day prior to their procedure. Eligible patients will be offered enrollment. Subjects will receive UPA 90mg one day prior to their procedure and no osmotic dilators. All subjects will receive pre-procedure misoprostol (600mcg 90 minutes prior to procedure). The investigators will observe patients through their planned procedure and report descriptive measures of its use.
- Conditions
- Termination of Pregnancy
- Being tested
- Ulipristal Acetate
- Keywords
- Ulipristal Acetate, Abortion, Cervical Preparation, Dilation and Evacuation
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal AcetateDrug
90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal Acetate | Experimental | Participants will be administered a one time dose of 90mg ulipristal acetate 18-24-hours prior to dilation and evacuation (surgical abortion) for cervical preparation. Receives: Drug: Ulipristal Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of cervical dilation
Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult"
Measured: Intraoperative
Secondary outcomes (6)
Need for additional mechanical dilation
Number of dilator increments in French required to dilate the internal os
Measured: Intraoperative: start of dilation to completion of dilation
Total procedure time
Minutes
Measured: Intraoperative: from speculum placement to speculum removal
Total operative time
Minutes
Measured: Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus
Complications
Number of cervical lacerations, uterine perforation, hemorrhage and need for transfer to high level of care
Measured: Intraoperative and postoperative through 8-weeks
Overall Pain Experienced
0-100mm on visual analog scale
Measured: 20-minutes postoperative
Number of procedures completed as scheduled
Measured: Time from enrollment to 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 posted14 Jan 2019
- Study start16 Apr 2019
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Termination of PregnancyStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802149
- Sponsor's protocol ID
- IRB-48756
- Acronym
- U-Prep
- Status last verified
- Jun 2020
- First submitted
- 7 Jan 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Will assess IPD sharing upon request.
Publications
Peterson SF, Lerma K, Shaw KA, Blumenthal PD. Cervical Preparation Using Ulipristal Acetate With Adjunct Misoprostol in Second-Trimester Surgical Abortions. Obstet Gynecol. 2022 May 1;139(5):907-909. doi: 10.1097/AOG.0000000000004754. Epub 2022 Apr 5. No abstract available.
PubMed 35576349
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT03802149
- Acronym / sponsor ID
- U-Prep / IRB-48756
- Conditions
- Termination of Pregnancy
- Keywords
- Ulipristal Acetate, Abortion, Cervical Preparation, Dilation and Evacuation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 14 Jan 2019 (actual)
- 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.
This is a prospective cohort study exploring a broadened use of ulipristal acetate as a cervical preparation agent for second trimester surgical abortion. Specifically, this pilot study will test the feasibility of using ulipristal as a pharmacologic cervical preparation with adjunct misoprostol prior to surgical abortion.
Detailed description
Second trimester abortion comprises <10% of all induced abortions in the United States but there is still an important need to provide this service to women. Prior to dilation and evacuation (D\&E), adequate preparation of the uterine cervix is an important part of preventing complications of the procedure. Commonly, this is done using osmotic dilators that are placed into the uterine cervix but cervical preparation can also be achieved using medications alone. Mifepristone is commonly used for this purpose but its use is regulated and often restricted due to the REMS (Risk Evaluation and Mitigation Strategy) program. The objective of this pilot study is to test the feasibility of using ulipristal, an oral medication similar to Mifepristone, as a medical form of cervical preparation prior to surgical abortion.This is a prospective cohort study investigating the use of ulipristal acetate (UPA) for pharmacologic cervical preparation with adjunct misoprostol prior to second trimester surgical abortion among women who are 16 to 18 6/7 weeks gestational age. Due the mechanism of action of UPA as a selective progesterone receptor modulator (SPRM) being similar to that of mifepristone, a medication known to be effective for cervical preparation, the investigators seek to describe the use of another SPRM for this same purpose. The investigators will conduct a pilot study assessing the feasibility of using UPA for cervical priming and report descriptive measures of its use. Per clinic protocols, patients over 16-weeks gestation attend a consult and cervical preparation appointment the day prior to their procedure. Eligible patients will be offered enrollment. Subjects will receive UPA 90mg one day prior to their procedure and no osmotic dilators. All subjects will receive pre-procedure misoprostol (600mcg 90 minutes prior to procedure). The investigators will observe patients through their planned procedure and report descriptive measures of its use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulipristal Acetate | Experimental | Drug: Ulipristal AcetateParticipants will be administered a one time dose of 90mg ulipristal acetate 18-24-hours prior to dilation and evacuation (surgical abortion) for cervical preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, aged 18 years or older
- Singleton, viable intrauterine pregnancy between 16 to 18 6/7 weeks of gestation (by ultrasound dating performed prior to or same day of enrollment visit)
- Consented for an induced, elective abortion
- English-speaking
- Able to consent for research project
Key exclusion criteria (16 listed)
- Inability to give informed consent
- Contraindications to surgical abortion under moderate sedation
- Allergy or previous unacceptable side effect from study medications
- Multiple gestation
- Intrauterine fetal demise or spontaneous abortion
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 |
|---|---|---|
| Ulipristal Acetate90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation | Drug | Ulipristal Acetate |
Primary outcome
Adequacy of cervical dilation
Time frame: Intraoperative
Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult"
6 secondary outcomes
Need for additional mechanical dilation
Time frame: Intraoperative: start of dilation to completion of dilation
Total procedure time
Time frame: Intraoperative: from speculum placement to speculum removal
Total operative time
Time frame: Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus
Complications
Time frame: Intraoperative and postoperative through 8-weeks
Overall Pain Experienced
Time frame: 20-minutes postoperative
Number of procedures completed as scheduled
Time frame: Time from enrollment to completion of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Derived from this study: PubMed 35576349Peterson SF, Lerma K, Shaw KA, Blumenthal PD. Cervical Preparation Using Ulipristal Acetate With Adjunct Misoprostol in Second-Trimester Surgical Abortions. Obstet Gynecol. 2022 May 1;139(5):907-909. doi: 10.1097/AOG.0000000000004754. Epub 2022 Apr 5. No abstract available.
- Individual participant dataSharing planned: No. Will assess IPD sharing upon request.
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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.
Principal Investigator, MD 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 Early Phase 1 study testing Ulipristal Acetate in people with Termination of Pregnancy, 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 6 inclusion and 16 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 1 Jul 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequacy of cervical dilation (time frame: Intraoperative). 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 NCT03802149, 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 1 Jul 2020.