Ulipristal Acetate for Use in Early Pregnancy Loss: A Phase 2 Pilot Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Percentage of Participants Recruited to Study Protocol
研究概览
简要总结
The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of early pregnancy loss. Patients will be followed to assess effective treatment of early pregnancy loss, additional interventions needed, side effects, adverse events and patient acceptability.
详细描述
Study Background: Early pregnancy loss affects approximately 10% of women throughout their reproductive lives and many women desire medical management of early pregnancy loss. Data from two large randomized controlled trials suggests that pretreatment with mifepristone 200mg, a selective progesterone receptor modulator, prior to administration of misoprostol 800mcg increases effectiveness of medical management of early pregnancy loss and decreases the need for subsequent surgical management. Ulipristal acetate (UPA) is another selective progesterone receptor modulator that may allow for similar priming of the cervix and sensitization of the myometrium to the prostaglandins to improve effectiveness of misoprostol in medical management of early pregnancy loss. Ulipristal acetate is available as a prescription medication through commercial pharmacies. Thus, utilizing UPA plus misoprostol for early pregnancy loss may improve access to patients.
Study Objectives:
Primary Objective:
- To assess if 90mg ulipristal acetate as an adjunct to 800mcg vaginal misoprostol is a feasible method for medical management of early pregnancy loss.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 18 years or older
- •English- or Spanish-speaking
- •Ultrasound examination showing a non-viable intrauterine pregnancy between 5- and 12-weeks' gestation or anembryonic gestation
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Provision of signed and dated informed consent form
排除标准
- •Desire for non-medical management of early pregnancy loss (either expectant management or surgical management)
- •Hemodynamically unstable
- •Evidence of incomplete or inevitable abortion (due to high efficacy of misoprostol alone)
- •Contraindication or allergy to ulipristal acetate or misoprostol (glaucoma, mitral stenosis, sickle cell anemia, chronic glucocorticoid use)
- •Evidence of a viable intrauterine pregnancy, ectopic pregnancy, or pregnancy with intrauterine device in place
- •Evidence of pelvic infection
- •Hemoglobin <9.5g/dL
- •Known cardiovascular disease (arrhythmia, cardiac failure, valvular disease, angina)
- •Known clotting or bleeding disorder, or on anticoagulation therapy
- •Use of the following medications that may influence metabolization of the study medications: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate
- •Use of CYP3A4 inhibitors within five elimination half-lives of ulipristal acetate or other strong CYP3A4 inhibitors
- •Chronic adrenal failure (risk of acute renal insufficiency)
- •Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
- •Any history of underlying liver disorder, including hepatitis
- •Elevation of any or all liver enzymes (alanine aminotransferase, aspartate aminotransferase, total bilirubin) above the upper limit of normal (ULN) at baseline testing prior to enrollment
- •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 intravenous (IV) drugs
- •A self-reported history of alcohol dependency or abuse
研究组 & 干预措施
UPA 90mg
Participants receive ulipristal acetate 90mg PO followed by self-administration of misoprostol 800mcg vaginally 6 to 18 hours following ulipristal acetate administration.
干预措施: Ulipristal Acetate Tablets (Drug)
UPA 90mg
Participants receive ulipristal acetate 90mg PO followed by self-administration of misoprostol 800mcg vaginally 6 to 18 hours following ulipristal acetate administration.
干预措施: Misoprostol Pill (Drug)
结局指标
主要结局
Percentage of Participants Recruited to Study Protocol
时间窗: Baseline
Measured as number of participants enrolled in study divided by number of patients screened for participation in study
Percentage of Participants Adherent to Study Protocol
时间窗: From admission until day 3 follow up, +/- 1 day
Measured as number of participants self reporting adherence to study intervention of ulipristal acetate followed by misoprostol taken 6-18 hours later divided by number of participants enrolled in study.
Percentage of Participants Retained in Study Protocol
时间窗: From admission until day 30 follow up, +/- 7 days
Measured as number of participants attending all required study visits (day 0, day 3, day 8, and day 30) divided by number of participants enrolled in study
次要结局
- Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention(From admission until day 3 follow up, +/- 1 day)
- Number of Participants With Treatment-Related Side Effects(From admission until day 30 follow up, +/- 7 days)
- Number of Participants With Treatment-Related Adverse Events(From admission until day 30 follow up, +/- 7 days)
- Median Acceptability of Study Intervention(From admission until day 30 follow up, +/- 7 days)