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Two Steps Forward, One Step Back:� Updates in Family Planning

Jessika Ralph, MD MSCI FACOG

Grand Rounds for the Department of Obstetrics, Gynecology, and Women’s Health

April 19, 2022

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  • I have no financial disclosures.

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Objectives

  • Review the use of many new contraceptives
  • Discuss the use of anti-D immune globulin for the prevention of Rh sensitization in first trimester abortion
  • Highlight the improved availability of medication abortion
  • Discuss the legal challenges to abortion care in the US

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Goals

4

Contraception

Legislation

Abortion

Annovera

Nexstellis

Slynd

Phexxi

Rh testing

SB8

https://pngtree.com/freepng/

doctor-cartoon-female_2991411.html

https://thenounproject.com/

term/bullhorn/8177/

Virtual Care

Twirla

Dobbs

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Contraception

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Contraception Update Highlights

  • A new estrogen!
  • A new progestin-only pill!
  • A low-dose combined hormonal patch!
  • A vaginal ring contraceptive that can be used for a year!
  • A new non-hormonal option!

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Slynd

  • Once daily pill containing 4mg drospirenone, taken in a 24/4 fashion

https://exeltisusa.com/our-womens-health-products/

Palacios S, Regidor PA, Colli E, et al.

Euro J of Contraception and Reproductive Health 2020.

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Nextstellis

  • Once daily pill containing drospirenone 3mg and estetrol 14.2mg, taken in a 24/4 fashion

https://www.maynepharma.com/media/2654/mayne-pharma-annual-report-2021-web.pdf

Creinin MD, Westhoff CL, Bouchard C, et al. Contraception 2021.

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Estetrol

  • Produced by the human fetal liver
  • No effect on coagulation factors and limited effect on lipids

Fruzzetti F,, Fidecicchi T, Montt Guevara MM, Simoncini TJ Clinical Med 2021.

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Twirla

  • Once weekly birth control patch containing 2.3mg ethinyl estradiol and 2.5mg levonorgestrel

Nelson AL, Kaunitz AM, Kroll R, et al. Contraception 2020.

https://www.twirla.com/hcp/

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Phexxi

  • On-demand, non-hormonal vaginal gel containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%)

https://www.today.com/health/fda-approves-first-non-hormonal-contraceptive-gel-here-s-how-t185616

Thomas MA, Chappell BT, Maximos B, et al. Contraception 2020.

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Annovera

  • Silicone elastomer vaginal system containing 103mg segestrone acetate and 17.4mg ethinyl estradiol designed for cyclic monthly use up to 1 year

https://www.popcouncil.org/research/

one-year-contraceptive-vaginal-ring

Jensen JT, Edelman AB, Chen BA, et al. Contraception 2018.

2.25in

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Segestrone Acetate

(Nestorone®)

  • Next generation progestin
  • Derivative of 19-norprogesterone
  • No androgenic or anabolic activity

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https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209627s000lbl.pdf

Kumar N, Koide SS, Tsong Y, Sundaram K. Steroids 2000.

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In the Works…�NES/T Contraceptive Gel

  • Created by the Pop Council
  • Currently in Phase 2 clinical trials

https://www.popcouncil.org/research/nestorone-testosterone-transdermal-gel-for-male-contraception

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Updates to Mirena 52mg LNG IUD

  • Now FDA-approved for contraception for 7 years of use!

https://www.mirena-us.com/about-mirena/mirena-effectiveness

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Abortion

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Abortion Update Highlights

  • Do we really need rhogam in the first trimester?
  • Medication abortion goes virtual, and gets popular

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No Rhogam if <8 Weeks Gestation

  • Clinical guidance in many countries, including the Denmark, the Netherlands, and Sweden, does not recommend Rhogam administration during first trimester abortion
  • Current evidence, though limited, suggests that during first trimester abortion feto-maternal hemorrhage does not reach the threshold for sensitization

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Soooo… Virtual Abortion Care?

https://www.wholewomanshealth.com/abortion-care/abortion-medication-by-mail/

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The FDA Risk Evaluation and Mitigation Strategies

  • FDA restrictions “to ensure the benefits outweigh the risks of a particular drug”
    • mifepristone cannot be sold in retail pharmacies
    • prescribers must be certified
    • patients must sign the FDA-approved patient agreement

https://www.earlyoptionpill.com/wp-content/uploads/2016/03/Patient-Agreement-Form-March2016-1.pdf

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Advocacy and Research in Action

https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration

https://www.aclu.org/press-releases/fda-announces-long-sought-after-review-harmful-restrictions-medication-abortion

nytimes.com/2021/12/16/health/abortion-pills-fda.html

May 2020

May 2021

December 2021

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Patients Can Now Get Mifepristone By Mail… Unless

https://www.kff.org/policy-watch/medication-abortion-telemedicine-innovations-and-barriers-during-the-covid-19-emergency/

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Half of Abortions Are Accomplished with Mife/Miso

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But… is it safe?

Jan-Mar 2020

Traditional, in-person medication abortion

(22,158)

Apr-Jun 2020

Traditional and telemedicine medication abortion

(29,984)

Eligibility criteria for no-test medication abortion:

  1. Known LMP
  2. Regular menses
  3. No use of hormonal contraceptives or breastfeeding in the last 3 months
  4. History of ectopic
  5. History of tubal surgery
  6. Absence of pelvic pain and vaginal bleeding

Aiken ARA, Lohr PA, Lord J et al. BJOG 2021.

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Aiken ARA, Lohr PA, Lord J et al. BJOG 2021.

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Aiken ARA, Lohr PA, Lord J et al. BJOG 2021.

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Upadhyay UD, Raymond EG, Koenig LR, et al. JAMA Internal Medicine 2022.

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Upadhyay UD, Raymond EG, Koenig LR, et al. JAMA Internal Medicine 2022.

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Upadhyay UD, Raymond EG, Koenig LR, et al. JAMA Internal Medicine 2022.

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Easy, Safe, and Effective!

https://www.wholewomanshealth.com/abortion-care/abortion-medication-by-mail/

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Legislation

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Legislation Update Highlights

  • How Texas prevailed and banned abortion
  • Will SCOTUS overturn Roe?

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Texas SB8

  • As of September 1, 2021:
    • Abortions may not be performed if the pregnancy has detectable fetal cardiac activity
    • Providers of abortions or those that aid in a person obtaining an abortion suspected to be in violation of this statute may be sued in civil court by private citizens for up to $10,000

https://www.guttmacher.org/article/2021/11/new-evidence-texas-residents-have-obtained-abortions-least-12-states-do-not-border

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SB8 Challenge Timeline

SB8 signed into law

WWH v Jackson filed in US District Court for the Western District of Texas

Defendants’ “motion to dismiss” is denied

Defendants appeal to the Fifth Circuit Court

May 2021

July 2021

August 2021

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SB8 Challenge Timeline

WWH et al file a petition for SCOTUS to hear the appeal

SCOTUS dismisses the case against Texas judges, clerks, and AG

Fifth Circuit Court hears appeal

Texas Supreme Court hears appeal

September 2021

December 2021

January 2022

February 2022

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SB8 Challenge Timeline

WWH et al file a petition for SCOTUS to hear the appeal

SCOTUS dismisses the case against Texas judges, clerks, and AG

Fifth Circuit Court hears appeal

Texas Supreme Court hears appeal

September 2021

December 2021

January 2022

February 2022

TO BE CONTINUED

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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SB8 Copycats

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Deep Breath!

https://greatist.com/happiness/breathing-exercises-relax#Bottom-line

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Mississippi Gestational Age Act

MS Gov

Phil Bryant

https://en.wikipedia.org/wiki/Phil_Bryant

March 2018

https://www.newyorker.com/podcast/politics-and-more/the-last-abortion-clinic-in-mississippi

Jackson Women’s Health

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Jackson Women’s Health v Dobbs

District Court strikes down abortion ban

Mississippi appeals the decision to the Fifth Circuit Court

Fifth Circuit Court upholds the District Court’s ruling

Mississippi appeals to the Supreme Court

Oral arguments are presented at the Supreme Court

November 2018

December 2019

June 2020

December 2021

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A Possible Outlook…

Myers C, Jones R, Upadhyay U. Contraception 2019.

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A Possible Outlook…

Myers C, Jones R, Upadhyay U. Contraception 2019.

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A Possible Outlook…

Myers C, Jones R, Upadhyay U. Contraception 2019.

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Minnesota Abortion Law

“We can think of few decisions more intimate, personal, and profound than a woman's decision between childbirth and abortion. Indeed, this decision is of such great import that it governs whether the woman will undergo extreme physical and psychological changes and whether she will create lifelong attachments and responsibilities. We therefore conclude that the right of privacy under the Minnesota Constitution encompasses a woman's right to decide to terminate her pregnancy.”

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Minnesota Abortion Law

“We can think of few decisions more intimate, personal, and profound than a woman's decision between childbirth and abortion. Indeed, this decision is of such great import that it governs whether the woman will undergo extreme physical and psychological changes and whether she will create lifelong attachments and responsibilities. We therefore conclude that the right of privacy under the Minnesota Constitution encompasses a woman's right to decide to terminate her pregnancy.

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Conclusions

  • We have the following new contraceptives to offer patients:
    • Nextstellis
    • Slynd
    • Twirla
    • Phexxi
    • Annovera
  • Rhogam is safe to defer during first trimester abortion
  • Virtual medication abortion is safe
  • Abortion rights continue to be litigated on the national level

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Thank You!

Questions?

ralph044@umn.edu

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