Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal Acetate | Drug | 90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of cervical dilation | Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult" | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Need for additional mechanical dilation | Number of dilator increments in French required to dilate the internal os | Intraoperative: start of dilation to completion of dilation |
| Total procedure time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35576349 | Derived | 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. |
Not provided
Not provided
Will assess IPD sharing upon request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Minutes
| Intraoperative: from speculum placement to speculum removal |
| Total operative time | Minutes | 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 | Intraoperative and postoperative through 8-weeks |
| Overall Pain Experienced | 0-100mm on visual analog scale | 20-minutes postoperative |
| Number of procedures completed as scheduled | Time from enrollment to completion of procedure |