Ulipristal Acetate for Cervical Preparation

Termination of Pregnancy Clinical Trial

— U-Prep  

Official title:

Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802149
• Other study ID #: IRB-48756
• Status: Completed
• Phase: Early Phase 1
• Start date: April 16, 2019
• Est. completion date: April 2, 2020

Study information

• Verified date: June 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 abortion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Termination of Pregnancy

Intervention

Drug:
• Ulipristal Acetate
90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequacy of cervical dilation	Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult"	Intraoperative
Secondary	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
Secondary	Total procedure time	Minutes	Intraoperative: from speculum placement to speculum removal
Secondary	Total operative time	Minutes	Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus
Secondary	Complications	Number of cervical lacerations, uterine perforation, hemorrhage and need for transfer to high level of care	Intraoperative and postoperative through 8-weeks
Secondary	Overall Pain Experienced	0-100mm on visual analog scale	20-minutes postoperative
Secondary	Number of procedures completed as scheduled		Time from enrollment to completion of procedure