Clinical trial NCT03802149: Ulipristal Acetate for Cervical Preparation
Official title: Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Termination of Pregnancy
Keywords: Ulipristal Acetate
Abortion
Cervical Preparation
Dilation and Evacuation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Adequacy of cervical dilation
timeFrame: Intraoperative
Secondary outcomes:
measure: Need for additional mechanical dilation
timeFrame: Intraoperative: start of dilation to completion of dilation
measure: Total procedure time
timeFrame: Intraoperative: from speculum placement to speculum removal
measure: Total operative time
timeFrame: Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus
measure: Complications
timeFrame: Intraoperative and postoperative through 8-weeks
measure: Overall Pain Experienced
timeFrame: 20-minutes postoperative
measure: Number of procedures completed as scheduled
timeFrame: Time from enrollment to completion of procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Principal Investigator, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.