Medical Sessions

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Pregnancy Unknown Location (PUL)

Dotsy Davis, BSRT, RDMS, RVT
Ultrasound Consultant, NIFLA

I. What is a pregnancy of unknown location?

A. Definition
B. Incidence
C. Occurrence
D. Sonographic Findings
E. Differentials
F. Prognosis

II. Presentation of study correlating thickness of endometrium to likelihood of ectopic pregnancy.

III. Differentials and how they present:

A. Miscarriage
B. Ectopic pregnancy/Cornual/heterotopic
C. Subchorionic hemorrhage
D. Free Fluid in the cul-de-sac
E. Molar pregnancy

IV. Conclusions/Outcomes

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The Ultrasound Visit: Pearls & Lessons Learned

Sandy Christiansen, MD
Care Net National Medical Director

Did you recently make a medical conversion, or are you new to medical services? Taking a practical, patient flow approach, learn tips and takeaways for best practices in conducting the medical visit. Who does the intake? What should be included? Options coaching highlights and more--vital signs?

I. Learning objectives

A. Participants will become familiar with a patient flow model that maximizes optimal patient care.
B. Participants will learn about the core components and significance of the reproductive health-focused medical intake and clinical evaluation during a limited obstetrical ultrasound exam appointment.
C. Participants will gain insight into conducting critical conversations during the ultrasound appointment, including pertinent health screenings.

II. What it means to be a medical clinic-the Paradigm Shift

III. Starting Assumptions & Context

A. Mission-focused medical pregnancy center
B. The primary client
C. The registered nurse is the clinic manager/sonographer
D. Nurses help patients, not clients

IV. Basic Requirements

A. Function under the authority and direction of a licensed physician who is in good standing with the physician’s state licensing board
B. Only utilize trained and licensed medical professionals to perform medical procedures, including ultrasounds
C. Carry sufficient medical liability coverage for the center and all medical personnel (unless they have their coverage).

V. Pre-appointment

A. PT contacts the center for an appt
B. Scheduler pre-screen
C. PT vs. PT/Sono appointments
D. Timing
E. Gestational age
F. Encourage partner attendance
G. Minors
H. What to expect

VI. Electronic vs. paper charting

A. CRMs: Take advantage of the capabilities you like
B. Example: texting consent forms, privacy forms
C. A blend of the two is the most common
D. Plan for growth

VII. An Example of Patient Visit Flow

VIII. Components of the PT/Sono Appointment

IX. The Medical Intake

X. Healthcare Screenings

XI. Options Coaching

XII. Spiritual History

XIII. Vital Signs

XIV. During the Ultrasound Exam

XV. Post-Sono Patient Debrief

XVI. Patient Follow-up

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Addressing Maternal and Infant Mortality Rates:
Empowering Women through Supportive Centers

Cherilyn Holloway
Certified Crisis Pregnancy Intervention Specialist,
Level 2 Certified Lay Counselor

I. Introduction

A. Importance of addressing maternal and infant mortality rates
B. The role of supportive centers in women’s healthcare journey

II. Affordable Housing as a Systemic Driver

A. Recognizing housing as a crucial factor in women’s choices
B. Advocating for safe and affordable housing options
C. Exploring alternatives to building individual maternity homes

III. Doula Programs for Black Mothers

A. Highlighting the research on Doulas impact on black mothers
B. The significance of the center visited in Baton Rouge, IL
C. The implementation of Doula programs in supporting black mothers
D. The role of being a NIFLA member in ensuring quality care

IV. Empowering Women through Advocacy

A. Centers as a source of information and education
B. Equipping clients with knowledge to advocate for themselves
C. Understanding and exercising birthing and post-birth rights

V. Addressing Implicit Bias in Healthcare Systems

A. Defining implicit bias and its implications
B. Becoming an ally to combat Implicit Bias
C. Supporting clients before, during, and after the birth experience

VI. Conclusion

A. Recap of key points discussed
B. Reiterating the importance of supportive centers
C. Encouraging collective efforts to address maternal and infant mortality rates

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Human Trafficking Among Us:
What Pregnancy Resource Centers Need to Know

Fidelma Rigby, MD
Professor of OB/GYN
Virginia Commonwealth
University School of Medicine

I. Introduction Slide

II. Disclaimers/ Trigger Slide

III. Outline of Talk

IV. Terms that we use/ don’t’ use.

V. Overview of HT: POLARIS Hotline and Heat Maps

a. Worldwide
b. In the US
c. In Virginia

VI. But why does this apply to PRCs?

VII. What difference can we make?

VIII. Example of one small act making a big difference.

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Chemical Abortion and Abortion Pill Reversal in 2023
Impacts on the Patient and the APR Treatment Team

Karen D. Poehailos, MD
Board Certified, American Board of Family Medicine
NIFLA Assistant Medical Director and Board Member
Abortion Pill Reversal Medical Advisory Team, Heartbeat International

 

Medical Abortion Procedures

A. Eligibility—FDA approved up to 10 weeks estimated gestational age (EGA)—70 days after LMP.
B. Prevalence—53.4% of all abortions in 2020 (51% were ≤ 9 weeks gestation, 2.5% were > 9 weeks’ gestation).
C. Access—CDC removed the requirement for dispensing mifepristone in certain health care settings (clinics, medical offices, hospitals) — “in-person dispensing requirement” on 12/16/2021. The REMS modification was approved on 1/3/2023.

1. 1. Can be written by a certified prescriber and dispensed by a certified pharmacy or under the supervision of a supervised prescriber.
   2. Prescriptions can be mailed via certified prescribers or pharmacies in addition to in-person.
   3. FDA does not “recommend” buying mifepristone online outside of the REMS program.

D. Access to Mifepristone (first medication in the protocol)

1. 1. The FDA lists Mifepristone on REMS (Risk Evaluation and Mitigation Strategy. REMS is for medications with serious safety concerns to ensure benefits outweigh risks—62 currently.
   2. Additionally, there are Elements to Assure Safe Use (ETASU). It is only given in specific settings; prescribers must hold a certified agreement with the manufacturer confirming assessment throughout the pregnancy, diagnose ectopic pregnancies, provide surgical abortion in the case of an incomplete abortion, and have a patient signed Patient Agreement form before dispensing the drug.
   3. There are calls to remove it from REMS.

E. Medications Used

1. Mifepristone (Mifeprex and an approved generic as of April 2019) blocks progesterone’s action, which is needed for the developing embryo.
2. Misoprostol causes softening of the cervix and uterine contractions.
3. Methotrexate (not often used) will stop the process of implantation.

[1] Abortion Surveillance—United States, 2020.  http://dx.doi.org/10.15585/mmwr.ss7110a1  Accessed 6/25/2023
[2] Questions and Answers on Mifeprex https://fda.gov/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex  Accessed 6/25/2023
[3] Kaiser Family Foundation. “Abortion.” https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/.  Accessed 3/9/2021
[4] Henney JE and Gayle HD.  Time to Reevaluate US Mifepristone Restrictions.  N Engl J Med, Aug 15, 2019, 381(7):597-8.

F. Medical Abortion Eligibility Criteria

1. Up to 70 days EGA (10 weeks after last menstrual period—LMP)
2. No ectopic pregnancy suspected, no IUD, and specific other medical exclusions.
3. Ability to follow instructions and follow-up contact.

G. Additional requirements:

Require pregnancy confirmation by clinical evaluation or ultrasound. There is no requirement for viability confirmation, assessment for suspected anemia, or blood type (Rh testing). It is suggested that these be waived for telehealth visits. However, in an ACOG document on Early Pregnancy Loss, Rh testing is still recommended to be considered in early pregnancy loss, especially later in the first trimester.

H. Timing of Mifepristone Abortion Protocol

Mifepristone 200 mg as a single dose, followed by misoprostol 800 mcg as a single dose 24-48 hours later.

G. Risks of Medical Abortion

Gastrointestinal, headache/dizziness, fever/chills/sweats, heavy bleeding, need for emergency D&C, need for surgical evaluation for incomplete abortion, continuing pregnancy, and infection.

 

ABORTION PILL REVERSAL

A. Network of over 1300 health care providers (physicians, NPs, PAs, and pregnancy centers) in a variety of settings.
B. To access: abortionpillreversal.com—gets patient in contact with a nurse who takes information and relays it to a provider who contacts the patient to start treatment.

Method of Action

A. Mifepristone binds to progesterone receptors in the uterus, where the placenta develops. If progesterone cannot reach the receptors, the placenta breaks down, the cervix softens, and contractions occur.
B. Progesterone is given if the second medication (misoprostol) has not been taken. Large doses can outcompete the mifepristone, more progesterone to the placenta and the pregnancy.

How well does it work?

A. The latest review of cases from the hotline was published in 2018.
B. The overall rate of reversal was 48%.
C. The highest rate of reversal was in two subgroups.

1. 1. Progesterone IM initially or exclusively 64% successful
   2. Progesterone oral high dose to end of first trimester 68% successful
      

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[5] Raymond EG, Grossman D, Mark A, et al. Commentary: No-test medication abortion: A sample protocol for increasing access during a pandemic and beyond. Contraception. 2020;101(6):361-366. doi:10.1016/j.contraception.2020.04.005
[6] ACOG Practice Bulletin: Early Pregnancy Loss.  Published Nov 2018. https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2018/11/early-pregnancy-loss  Accessed 6/25/2023
[7] Practice Bulletin No. 181: Prevention of Rh D Alloimmunization, Obstetrics & Gynecology: August 2017 - Volume 130 - Issue 2 - p e57-e70  doi: 10.1097/AOG.0000000000002232
[8] https://www.heartbeatinternational.org/images/ImpactReports/APRN_Impact_Report_2022.pdf  Accessed 6/25/2023
[9] Delgado G, Condly SJ, Davenport M, Tinnakornsrisuphap T, Mack J, Khauv V, Zhou PS.   A Case Study Detailing the Successful Reversal of the Effects of Mifepristone Using Progesterone.   Issues Law Med, Spring 2018, 33(1): 21-31.

What is the rate of continuing pregnancy if misoprostol is not taken but no progesterone?

In studies where mifepristone alone was taken without misoprostol, the highest survival, 23% using a single 200 mcg dose, now in the FDA protocol. The 2018 study used 25% to look statistically at survival.

Does mifepristone harm the embryo?

ACOG Bulletin on Medication Abortion up to 70 Days of Gestation states that no evidence exists for the teratogenic effect of mifepristone.
BUT—misoprostol and methotrexate can cause birth defects.

What is the track record of progesterone in pregnancy?

It has been used safely in pregnancy for over 50 years. American Society of Reproductive Medicine states no long-term risks when used in pregnancy. The current FDA classification in pregnancy is P2 “Benefits are likely to exceed the risk.”

Are the APR survivors at increased risk for birth defects?

No, the rate was 2.7% in the 2018 study, compared favorably to the general population rate of 3%.

What is required of the patient?

A. The patient is willing to see the doctor as soon as possible for an exam, ultrasound, and labs.
B. The oral regimen is easiest to start quickly (even before seeing the doctor) and costs reasonable.

What about Methotrexate?  Can it be reversed?

Information, at this point, is anecdotal. A physician who has attempted is only aware of six successes. He knows two were born with a missing toe on each foot. The one he cared for was the only known defect, but the data is small and incomplete.

Methotrexate can cause birth defects—careful consent and documentation are needed. The protocol is available through APR to providers.

HOW DOES THIS IMPACT PATIENTS?
WHAT ABOUT THE HOTLINE PROVIDERS/PREGNANCY MEDICAL CLINICS?

For patients—access to medication abortion is easier than ever. They can obtain pills without seeing a physician in person, without verification of intrauterine pregnancy or gestational age, without Rh testing, and without knowing whether consent is being forced or pills being hoarded to give women without consent, hiding potential sex trafficking, sexual assault, and sexual activity among minors.

For APR Network providers/pregnancy centers—women may be starting medication abortions without verification of intrauterine pregnancy, so hotline patients may not have had their pregnancy verified as an IUP making early ultrasound access a must. Will women contact your center asking to verify that their abortion was complete by ultrasound?

[10] American College of Obstetricians and Gynecologists Practice Bulletin, Medication Abortion Up to 70 Days of Gestation, October 2020.

 

EMOTIONAL WEIGHT OF ABORTION REVERSAL FOR APR Network PATIENTS, APR Network PROVIDERS, AND PREGNANCY CENTERS— “the agony and the ecstasy.”

The “agony”

--women calling the hotline and then not answering the providers when they call back, or not showing up for the ultrasound, or returning texts

--failures—roughly 1/3 fail. They can fail abruptly after a reassuring ultrasound when they’re at a more advanced gestational age that would normally do better. The patients need to be supported, but so do the teams. For the patients, referral to pregnancy loss resources (but do they fit into the existing categories very well?) For the teams, utilize prayer hotlines, debriefings afterward, and strong prayer life.

The “ecstasy”

- helping women in moments of tremendous need

- ability to walk with them, spiritual sharing, staying with them through the pregnancy

- sometimes, they stay in touch for years!

In EITHER case (if the reversal attempt is successful or unfortunately fails), we should remember that we are God’s hands and feet here and are asked to be faithful and provide the best care we can.

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[9] Delgado G, Condly SJ, Davenport M, Tinnakornsrisuphap T, Mack J, Khauv V, Zhou PS.   A Case Study Detailing the Successful Reversal of the Effects of Mifepristone Using Progesterone.   Issues Law Med, Spring 2018, 33(1): 21-31.

[10] American College of Obstetricians and Gynecologists Practice Bulletin, Medication Abortion Up to 70 Days of Gestation, October 2020.

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A Summary of the Latest Legal
Pitfalls and Best Practices

Anne O’Connor, JD
Vice President of Legal Affairs, NIFLA
Angie Thomas, JD
General Counsel, NIFLA

I. External Attacks

A. Legislative Update

1. Attacks on providers of APR (CO)
2. Attacks on PCs – Deceptive Advertising (IL)
3. Attacks on PCs from AGs (NJ)

B. Litigation Update

1. IL case
2. NY Boss Bill
3. CO case
4. Abortion Pill case

C. ACOG White Paper on CPCs

II. Best Practices to Limit Attacks

A. Medical

1. Medical Malpractice Insurance
2. Ectopic Precautions
3. Early Ultrasounds
4. Additional Scans
5. HIPAA

a. Security Risk Assessment
b. BAAs
c. Training

6. Abortion pill Reversal (APR)

a. Provider
b. Consulting center

7. Proper Training for Medical Personnel

a. Review courses and guidelines for ultrasound training
b. Review scope of practice and who should do what service (The nurse should do the medical assessment, not the advocate.)
c. Medical Policies and Procedures

8. Post-Abortion Assessments - review policy

9. Release of Patient Information

a. To the patient
b. To third parties

10. Transgender patients

11. Exit Survey and Patient Complaint Form

B. Websites and Advertising

1. We will analyze several sample advertisements and provide recommendations.
2. Terms of Use and Privacy Policy
3. NPP

C. Employment

1. Hiring
2. Importance of religious foundations

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Bioeffects, Risk and Safety Considerations
in Obstetrical Sonography

Dr. Fred Kremkau
Professor of Radiological Sciences
Wake Forest University School of Medicine

I. Interaction Mechanisms

A. Heating
B. Cavitation

II. Experimental Studies

A. Cells
B. Mammals
C. Humans

III. Official Statements

A. AIUM
B. WFUMB

IV. Prudent Use

A. U.S. Food and Drug Administration (FDA)
B. ALARA Principle
C. Instrument Outputs
D. Output Display Standard (ODS)
E. First-trimester Exposure