NCT03802149

Ulipristal Acetate for Cervical Preparation

Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Termination of Pregnancy

Interventions

Type	Name	Description
DRUG	Ulipristal Acetate	90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation

Timeline

• Start date: 2019-04-16
• Primary completion: 2020-04-02
• Completion: 2020-04-02
• First posted: 2019-01-14
• Last updated: 2020-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study