NCT03802149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 16, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

January 7, 2019

Last Update Submit

June 30, 2020

Conditions

Termination of Pregnancy

Keywords

Ulipristal AcetateAbortionCervical PreparationDilation and Evacuation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Need for additional mechanical dilation

    Intraoperative: start of dilation to completion of dilation

  • Total procedure time

    Intraoperative: from speculum placement to speculum removal

  • Total operative time

    Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus

  • Complications

    Intraoperative and postoperative through 8-weeks

  • Overall Pain Experienced

    20-minutes postoperative

  • +1 more secondary outcomes

Study Arms (1)

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.

Drug: Ulipristal Acetate

Interventions

Ulipristal AcetateDRUG

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

Ulipristal Acetate

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 35576349DERIVED

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Principal Investigator, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 14, 2019

Study Start

April 16, 2019

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Will assess IPD sharing upon request.

Locations

US(1)