Clinical trial NCT03774745: Blocking Mifepristone Action With Progesterone
Official title: A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pregnancy, Unwanted
Keywords: mifepristone
progesterone
abortion
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2018-12-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled trial
Primary purpose: TREATMENT

Brief summary: Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.

Detailed description: Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. The use of medications to cause abortion has been around for almost 70 years but the modern era of medical abortion treatment evolved with the development of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater than progesterone itself.

Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of continuing pregnancy is still present, especially as gestation advances. While most women opt for further treatment in these scenarios, such as surgical aspiration, there are some who decide to continue the pregnancy. Thus, even following treatment, some women do change their mind.

No well-done study has evaluated whether such treatment works. Poorly controlled case series are not evidence and systematic reviews of continuing pregnancy rates after mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This study is also a first step to understanding if large studies evaluating mifepristone antagonization with high-dose progesterone are indicated and if placebo-controlled randomized trials can be successfully completed when evaluating this question.

Eligibility criteria: Inclusion Criteria:

1. Pregnant females 18 years and older at enrollment.
2. Seeking surgical abortion at 44-63 days' gestation on Study day 1.
3. Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
4. Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
5. English-speaking
6. Willing to sign informed consent and follow study protocol.
7. Willing to experience potential expulsion of the pregnancy with mifepristone treatment.

Exclusion Criteria:

1. Medical contraindications to medical abortion.

   1. Poorly controlled hypertension (systolic BP \>160 or diastolic BP \>95)
   2. Significant anemia - known recent hemoglobin \<9.5 gm/dL
   3. Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
   4. Breastfeeding
   5. Coagulopathy or therapeutic coagulation
   6. Ultrasound evidence of molar or ectopic pregnancy
   7. Chronic systemic corticosteroid use
   8. Adrenal disease
   9. Sickle cell anemia with frequent/recent crises
   10. Glaucoma
2. IUD in place during conception, even if removed.
3. Peanut allergy.
4. Known intolerance of mifepristone or progesterone.
5. Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.

Primary outcomes:
measure: Continuing Pregnancy Based on Ultrasound Examination
timeFrame: at 14-16 days after mifepristone administration
Secondary outcomes:
measure: Expulsion During Follow-up Evaluation
timeFrame: up to 16 days after mifepristone administration
measure: Number of Participants With Adverse Events During Follow-up Evaluation
timeFrame: up to 16 days after mifepristone administration
measure: Medical Safety During Treatment and Follow-up
timeFrame: up to 16 days after mifepristone administration
measure: Number of Participants With Change in Serum Progesterone and hCG During Follow-up
timeFrame: up to 16 days after mifepristone administration
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Planned Parenthood Mar Monte
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Sacramento
country: United States
facility: Family Planning Associates
state: California
Study officials:
affiliation: University of California, Davis
name: Mitchell D Creinin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Creinin MD, Hou MY, Dalton L, Steward R, Chen MJ. Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):158-165. doi: 10.1097/AOG.0000000000003620.