{"id":197591,"date":"2019-03-04T11:14:32","date_gmt":"2019-03-04T17:14:32","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=197591"},"modified":"2020-05-15T13:56:37","modified_gmt":"2020-05-15T18:56:37","slug":"study-abortion-pill-not-pregnant","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/study-abortion-pill-not-pregnant\/","title":{"rendered":"‘Experimental’ study to dispense abortion pill to women not yet pregnant, just ‘in case’"},"content":{"rendered":"
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UPDATE, 6\/20\/19<\/strong>: Live Action News learned today that this study has now been withdrawn<\/em> and is “not proceeding at this time.” No reasons were given.<\/p>\n

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Clinical trial withdrawn (screenshot)<\/p><\/div>\n

3\/4\/19<\/strong>: An abortion pill study which seeks to provide the deadly<\/a> drugs to women who are not even pregnant yet<\/strong> has begun in California.\u00a0The “experimental” study,\u00a0published<\/a> at the FDA’s Clinical Trials website for participants who are “not currently pregnant and not desiring to be pregnant in the next year,” appears to be in its beginning stages. It will be conducted under the direction of abortionist Daniel Grossman by the University of California, San Francisco (UCSF) and\u00a0is expected to be completed in April of 2020.\u00a0Study participants will receive:<\/p>\n

    \n
  • Drug:\u00a0Mifeprex\u00ae<\/span>\u00a0(Mifepristone 200 mg)<\/li>\n
  • Drug: Misoprostol 800 mcg<\/li>\n
  • Drug: ella\u00ae (ulipristal acetate emergency contraception 30 mg)<\/li>\n
  • Diagnostic Test: AccuHome\u00ae Pregnancy OTC Test<\/li>\n<\/ul>\n

    Currently, under the FDA’s REMS system<\/a>, the pill (Mifeprex) is only permitted to be “dispensed\u00a0in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider,” which have the ability to (1) d<\/span>ate pregnancies accurately and to diagnose ectopic pregnancies, and (2) provide any necessary surgical intervention, or have made arrangements for others to provide for such care.<\/p>\n

    However, this abortion study’s participants will not be examined for pregnancy, but will receive a mere “over the phone” consultation, with pregnancy to be estimated based on the date of the last recalled menstrual period.<\/p>\n

    What could possibly go wrong?<\/strong><\/em> Well, a lot, actually.<\/p>\n

    \"Image:

    Abortion drug study for non pregnant women Daniel Grossman<\/p><\/div>\n

    \"Image:

    RU486 abortion pill Mifeprex (Image credit: Danco)<\/p><\/div>\n

    The purpose of the study, “Advance Provision of Medication Abortion,<\/a>” is to”test the model of advance provision of medication abortion (MAB).”<\/p>\n

    In this model, patients at risk of unintended pregnancy and with a desire to avoid pregnancy will be assessed by a clinician and provided counseling on pregnancy recognition and testing, as well as how to administer MAB at home. For this pilot study, only patients who have previously had a MAB will be included, since this population has reported the highest interest in the model, and they are also already familiar with how to use the medications.<\/em><\/p>\n

    But in this trial, abortion inducing pills will be given to women before<\/strong> becoming pregnant:<\/p>\n

    The clinician will provide Mifeprex\u00ae and misoprostol to the patient at the time of counseling in case the patient becomes pregnant and wants to terminate the pregnancy<\/strong> using the medications up to 10 weeks gestation. Patients will contact a study clinician for an over-the-phone assessment of eligibility for MAB, including assessment of gestational age, before self-administration of Mifeprex\u00ae and misoprostol, and then attend a follow-up visit with the clinician.<\/em><\/p>\n

    Despite the potentially risky possibility<\/a> of miscalculating the pregnancy and then taking the pills past the gestational limit of 10 weeks — or an ectopic pregnancy, which often requires ultrasound to determine — the posted<\/a> “secondary outcome” states, “Gestational age will be calculated by last menstrual period during the over-the-phone clinical evaluation<\/strong> with a study clinician. Ultrasound data will be analyzed if obtained.”<\/p>\n

    “Participants will be given clear instructions on study participation and returning unused medications<\/strong> in an appropriate time frame,” the study claims.<\/p>\n