A Critical Examination of Abortion Terminology

Today we are reviewing a new document from SMFM’s Reproductive Health Committee regarding the vocabulary surrounding abortion. Joining us are two of the paper’s lead authors: Dr. Cara Heuser, an associate professor of OB/GYN at University of Utah; and Dr. Sarah Horvath, an assistant professor of OB/GYN at Penn State University.

Their paper and their comments in today’s podcasts are really worth listening to. We also recommend some additional resources or guides for reproductive health advocacy:

SMFM: a number of resources and ways to get involved are here.

ACOG: the ACOG IMPACT project on abortion care training can be reviewed here.

SFP: SFP regularly updates clinical guidance and educational material surrounding abortion care, best practices, and data.

Espresso: Update to the Mifespristone REMS Requirements

Reading: ACOG Practice Advisory: Updated Mifepristone REMS Requirements

Background 

• What is mifepristone? 

• As you probably know, mife is used in combination with misoprostol as part of medication abortion 

• This method is safe, effective, and FDA-approved 

• Can also be used for early pregnancy loss 

• Check out our medication abortion and telehealth abortion episodes! 

• However: 

• Starting in 2011, the FDA implemented the Mifepristone REMS (risk evaluation and mitigation strategy) Program placed several restrictions on mifepristone distribution 

• There needed to be an in-person dispensing requirement 

• Needed to be dispensed in a clinic, medical office, or hospital by or under direct supervision of a certified clinician 

• So patients could not get the mifepristone in a retail pharmacy or by mail 

• ACOG has long advocated for removal of this restriction 

• Doesn’t make care safer 

• Not based on medical evidence 

• Creates barriers to clinician and patient access to medication abortion and medical management of early pregnancy loss 

• Disproportionately burdens communities already facing structural barriers to care 

Why are we making this episode? 

• Timeline 

• During COVID-19, with advocacy, the FDA halted enforcement of the REMS in-person dispensing requirement due to public health emergency

• This allowed telehealth provision of mifepristone and also by mail in some states  

• December 2021 - FDA completed a review of the Mifepristone REMS Program and determined that modifications were warranted to reflect long-standing safety data, improve patient access, and reduce burden on health care delivery 

• January 3, 2023 - Drug manufacturer’s submission of updated prescribing information, etc. and was approved by FDA 

• Updates 

• Permanent removal of in-person dispensing requirement 

• So in addition to clinics, medical offices, hospital: certified pharmacies can now dispense mifepristone to patients with prescription from certified prescriber 

• Mifepristone can be dispensed in-person or by mail 

• Addition of a pharmacy certification requirement 

• Retail pharmacies that meet certain requirements and complete a Pharmacy Agreement Form can now dispense mifepristone to patients to patients who have a prescription from a certified prescriber 

• Find the documents can be found on the FDA website.

What does this mean for us and for our patients? 

• Increase access to medication abortion 

• Maybe – can still be dependent on state-specific laws and ability and willingness of retail pharmacies to achieve REMS certification 

• Some states restrict abortion

• Some states restrict telehealth access, may still require in-person dispensing of mifepristone, and regulation of medications by mail 

• So… the REMS requirements still remain as a medically unnecessary barrier to obtaining this medication 

Abortion: Telemedicine and Self-Management

Today we’re joined by Dr. Sarah Gutman, who is an assistant professor of OB/GYN at the University of Pennsylvania, and a recent graduate of their fellowship in complex family planning. She’s joining us today to talk about some of the most important and interesting topics trending in the weeks after the Dobbs vs Jackson Women’s Health: self-managed abortion and telemedicine abortion.

What is telemedicine abortion?

• Provision of medication abortion care using telemedicine services, typically fully remote but can involve some degree of in-person contact for part of the process, under the supervision of a medical provider.

• Who are the appropriate candidates for telemedicine abortion?

  • Eligibility criteria for studies evaluating telemedicine abortion have typically included:

    • Pregnancy less than 10 weeks gestation,

    • No contraindications to mifepristone or misoprostol and

    • The ability to receive mife/miso by mail

• What are the steps of a typical telemedicine abortion visit?

  • Initial consult – confirmation of dating, review of medical history/risks factors, discussion of how medication should be used and expectations for abortion process.

  • Patients should be certain of their LMP within one week, and it should be <77days before anticipated start of mifepristone

  • Evaluate for symptoms or risk factors for ectopic pregnancy, including vaginal bleeding, pelvic pain, prior ectopic, current IUD use, prior tubal surgery

    • Interestingly, the rate of ectopic pregnancy among patients seeking abortion is lower than the general population – between 1.5 – 6 per 1,000 pregnancies compared to about 20 per 1,000 pregnancies in the general population

  • Ensure no contraindications for medication abortion

    • RH type and hemogloblin are not needed

  • Receipt of medications – due to restrictions in mifepristone accessibility, typically this has been through the mail

• Medication abortion has been covered by the podcast in the past, but as a reminder: the two medications used for medication abortion are mifepristone and misoprostol.

  • Mifepristone is a taken orally as a one-time 200mg dose

  • Misoprostol can be used vaginally, sublingually, or buccally, 800mcg are given initially with the option to repeat a dose if needed.

    • Patients are informed to take within 48h of mifepristone administration.

    • Consider a second dose if GA >63 days or no bleeding in 24 hours.

  • Analgesics, antiemetics – many providers give ibuprofen and Zofran

• When to seek help:

  • Heavy bleeding soaking >2 pads/hour for more than 2 hours,

  • Passing blood clots larger than a lemon, or

  • Symptoms of blood loss such as feeling dizzy/lightheaded.

• Follow up

  • Symptoms – can be assessed at 7-14 days through a text, secure messaging, telephone all, or video.

    • Patients are counseled to expect bleeding heavier than a period, and that they may pass blood clots and see some tan/pink tissue.

  • Urine pregnancy tests – given 4 to 6 weeks following the abortion

What is the evidence behind telemedicine abortion?

• Efficacy is very high – around 95% of abortions are completed without needing a procedure.

• Complications are exceedingly rare.

  • Around 6% of patients visit an ER or urgent care center related to the abortion

  • The rate of adverse events is less than 1%, with hospitalization <0.5%, transfusion 0.4%, infection <0.1%

What is self-managed abortion?

• Self-managed abortion has also been referred to as self-sourced medication abortion (SSMA)

• Society of Family Planning definition:

  • “It refers to any action taken to end a pregnancy outside of the formal healthcare system, and includes self-sourcing mifepristone and/or misoprostol, consuming herbs or botanicals, ingesting toxic substances, and using physical methods.”

• Historically, people fearing criminalization or unable to access abortion care often turned to unsafe or invasive methods of self-managing their abortion – think of the abortion scene in ‘Dirty Dancing’ and the use of a coat-hanger as a sign of an unsafe abortion.

  • However, increased access to the medications used for abortion, in particular misoprostol, had made self-managed abortion much safer and more effective.

  • Other reasons besides access that people may choose self-managed abortion, including privacy, discomfort with the available medical services, and person safety.

What are the components of SMA?

• Similar to telemedicine abortion, SMA includes assessment of eligibility, administration of abortion medications, management of the abortion process, and assessment of abortion completion.

  • These actions are all taken without the formal guidance of a healthcare provider.

  • People who self-manage their medication abortions should be able to estimate their gestational age using their last menstrual period and be aware of their cycle regularity and any contraception use.

• There are many clinical resources available online, including through the Reproductive Health Access Project, Doctors without Borders, and Aid Access.

• The WHO recommends mifepristone followed by misoprostol.

  • However, if mifepristone is not accessible, misoprostol can be used alone, typically 800 mcg used vaginally, sublingually, or buccally repeated every 3 hours or up to 3 doses until expulsion occurs.

• How common is SMA?

  • Recent cross-sectional data suggests 7% of individuals in the US attempt SMA at some point in their lifetime, and this is likely growing due to increased restrictions on abortion access.

• What is the safety and efficacy of SMA?

  • Data is limited: it’s difficult to study something that is outside the healthcare system.

  • However, from the data we have available and by extrapolating data from the telemedicine abortion models with lowest amount of supervision, self-managed abortion using mifepristone and misoprostol appears to be as safe and effective as medication abortion within a clinical setting.

  • A meta-analysis of misoprostol alone regimens used <91 days gestation found a 6.8% ongoing pregnancy rate

    • Serious adverse events occur <1% of the time.

• How can providers support patients who have chosen self-managed abortion?

  • When people are criminalized for abortion, it is often due to a healthcare provider reporting them to the police.

  • Currently, there are no mandated reporting laws for healthcare providers.

  • There is legal help available for patients concerned about their options and criminalization, such as If/When/How

    • People of color and low-income individuals are most likely to be targeted and disproportionately criminalized.

Summary

• Telemedicine abortion is the provision of medication abortion through telehealth under a healthcare providers supervision. Self-managed abortion is actions taken outside the formal healthcare setting to end a pregnancy.

• Both telemedicine abortion and self-managed abortion using mifepristone and misoprostol are remarkably safe and effective.

• While protocols vary, typically patients receiving telemedicine abortion should be at or below 10 weeks gestation, should not have any risk factors or symptoms concerning for ectopic pregnancy, and should not have any contraindications to taking mifepristone or misoprostol. After taking their medications, they should be able to monitor their vaginal bleeding and cramping and take a home urine pregnancy test in 4-6 weeks to confirm completion of the abortion.

• Importantly, there are no laws mandating that healthcare providers report patients for suspected self-managed abortion. If patients are concerned about criminalization there are legal resources available such as If/When/How.

Additional Resources

• Society of Family Planning interim clinical recommendations: Self-managed abortion (https://www.societyfp.org/society-of-family-planning-interim-clinical-recommendations-self-managed-abortion/)

• Raymond et al. TelAbortion: evaluation of a direct to patient telemedicine abortion service in the United States. Contraception 2019 (https://doi.org/10.1016/j.contraception.2019.05.013)

• Baldwin et al. Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic. Contraception 2021 (DOI: 10.1016/j.contraception.2021.03.019)

The Contraceptive CHOICE Project

Background 

• Title: The Contraceptive CHOICE Project: Reducing Barriers to Long-Acting Reversible Contraception 

• Publishing Info:

  • Done by a group at the department of Ob/Gyn at Washington St. Louis School of Medicine (first author was a PhD!) 

  • Published in AJOG in 2010 (first 2500 patients) 

  • Follow up was published in Clinical Ob/Gyn 2014 - 9256 women 

• Who funded this study 

  • Funded by an anonymous foundation + also Midcareer Investigator Award in women’s Health Research, Clinical Translational Science Award, and NCRR 

• Why was this study done? 

  • About half of the pregnancies that occur in the US are unintended 

  • A lot of pregnancies results from incorrect or inconsistent use of birth control methods 

  • At the time, LARC use was low, <3% of women in the US used a LARC 

  • CHOICE was done to promote use of LARCs in the St. Louis region 

• Goal: 

  • Objective: provide no-cost contraception to a large number of women in that region 

    • Secondary: reduce unintended pregnancy at the population level 

  • In order to accomplish, had to overcome two barriers: 

    • Financial obstacles 

    • Lack of patient awareness of LARC method safety and efficacy 

Methods 

• Type of study

  • Prospective cohort study of 10,000 women in St. Louis region

• Intervention

  • Provided each participant with the contraceptive of her choice at no cost for three years  

• Subject recruitment

  • Convenience sample - meaning no randomization, etc. Just chose women at specific clinic locations and via general awareness of CHOICE through medical providers 

    • Clinics were university-affiliated clinics, two facilities providing abortion services, community clinics, etc. 

  • Eligibility: 

    • Age 14-45

    • Reside in or seek clinical services at recruitment sites in St. Louis region 

    • Sexually active with male partner in last 6 months or anticipate sexual activity with male partner in next 6 months 

    • No tubal or hysterectomy 

    • Does not desire pregnancy in next year 

    • Not currently using contraceptive method or interested in starting a new reversible contraceptive method 

  • Recruitment and screening was done by person on site or by telephone 

    • Person was trained with scripted intro to LARC methods if LNG-IUD, copper IUD, and subdermal implant

    • Enrollment occurs in 1.5-2 hr in person process

      • Rule out pregnancy

      • Due to staff constraints, not everyone got the same counseling - so at the community sites, patients received routine family planning counseling 

    • Informed consent 

  • LARC method

    • If they wanted a LARC method, then they had insertion by trained professional 

    • Emergency contraception was provided if needed  

  • Follow up: phone follow up at 3, 6, 12, 18, 24, 30, 36 months post enrollment 

    • Given $10 for each completed survey 

    • Also screened for gonorrhea and chlamydia at 12, 24, and 36 month contacts 

    • Huge undertaking to follow people for 3 years! 

    • Collected info on baseline demographics, OB and gyn history, etc. 

Results 

• Findings for first 2500 women (2010 study) 

  • Population

    • Between August 2007 - December 2008, screened 4107 women, 3522 met eligibility criteria, 2500 enrolled 

    • 74% (1845/2500) of enrollments occurred at university-based recruitment site  

    • Average age: 25 (range 14-45), majority were 25 or younger (only 36.9% >25)  

    • 49% white, 44% black 

    • 42% no insurance, more than half reported difficulty paying for transportation food, housing, or medications 

    • 63.7% single or never married

    • 41% nulliparous, 54% of parous women reported having 2 or more children 

    • 67.1% chose a LARC, and 32.9% chose other methods 

      • Of those that chose LARCs: 46.8% LNG-IUD, 9.3% Copper IUD, 11.0% subdermal implant 

      • LARC users more likely to be recruited at an abnortion clinic (RR 1.2, 95% CI 1.1-1.2), report greater parity, or history of abrotion 

      • Those who reported black or other race, single or never married, one or no lifetime partners were less likely to choose LARC 

• Findings for all the patients 

  • Demographics were overall pretty similar 

  • At the end of the study:

    • LARC users were more likely than non-LARC users to continue at the 12 and 24 months with method (86% vs. 55% at 12 months, 77% vs 41% at 24 months)  

    • At 12 months, the IUDs had highest continuation rates (88% for LNG-IUD, 84% for copper iUD), same at 24 months (79% for LNG-IUD and 77% copper) 

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• Some people voiced concern that with increased LARC use, there may be increase in high risk sexual behavior — no evidence to suggest that there was increased sexual risk-taking 

  • 71% reported no change in their number of sexual partners at 6 and 12 months; only 16% report increase, and of those, 80% experienced a change from 0 to 1 partners 

  • Percent of women reporting multiple partners at baseline was significantly reduced at 6 and 12 months (5.2%, 3.5%, 3.3% respectively) 

• Reduction of unintended pregnancies! 

  • Failure rates for pill, patch, and ring = 4.8%, 7.8%, 9.4% at 1, 2, and 3 years 

  • Failure rate for LARC users remained <1% throughout the 3 year follow up (cumulative was 0.3%, 0.6%, and 0.9% at each year respectively) 

  • Non-LARC users were 22x as likely to experience an unintended pregnancy compared to LARC counterparts 

  • Adolescent users of pill, patch, or ring were twice as likely as older women to experience unintended pregnancies 

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Very cool: super decreased rates of pregnancy, birth and abortion among teens! 

National for each: 158/1000, 94/1000, 41/1000

CHOICE: 34/1000, 19.4/1000, 9.7/1000 - Greater than 75% reduction! 

• Contraception in the overweight and obese populations 

  • BMI was not found to be significant factor associated with increased risk of method failure for pill, patch, or vaginal ring (there were a total of 334 unintended pregnancies, 128 were determined to be contraceptive failure)

  • Weight gain

    • Those who perceived weight gain were more likely to be implant or DMPA users 

    • Objective weight gain on average was 10.3 lbs 

    • Adjusted models only identified black race as having significant association with weight gain in 12 months 

•  STIs: Prevalence of GC, CT, and trich were higher in the CHOICE cohort than the national average at baseline 

  • 7.9% had one or more 

Conclusions 

• Huge # of women seeking reversible contraception 

  • When barriers of cost, access, and knowledge are removed, women choose the most effective and least-user dependent methods more often 

    • In general population, LARC use was 3% 

    • In this population, 46% chose LNG IUD, 11.9% chose Copper IUD, and 16.9% chose implant 

  • Continue to use them 

  • Also found they were highly satisfied 

  • Also decrease risk of unintended pregnancies, teen pregnancies 

What do we do now? 

• Some pretty cool follow up: 

  • Colorado Family Planning Initiative - provides access to long-acting reversible contraception 

  • Teen birth rates cut in half, abortion rates cut in half 

  • Average rate of first birth increased by 1.2 years among all women 

  • Cost avoided: $66.1-69.6 million

• Per CDC we have definitely increased LARC use now! 

  • 2015-2017: LARC use was up to 10.3% 

  • LARC was highest among women 20-29 (13.1%)

The CREST Study

Here’s the RoshReview Question of the Week!

Which of the following methods of sterilization has the highest relative risk for ectopic pregnancy?

• Bipolar coagulation

• Postpartum partial salpingectomy

• Silicone band methods

• Spring clips

Check your answer and get a special deal on RoshReview at the link above!

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Background: 

• Who did the study? 

  • Study was done by the US Collaborative Review of Sterilization Working Group 

  • CREST was part of the CDC and conducted with the NICHD 

  • Conducted with 10 year follow up and was done at multiple medical centers (Baltimore, MD, Buffalo, NY, Chapel Hill, NC, Honolulu, HI, Houston, TX, Memphis, TN, Sacramento CA, St. Louis, MO, San Francisco, CA) 

• Where was the study published? 

  • AJOG in 1996 

  • Presented at the Annual Meeting of the American Gynecological and Obstetrical Society in Napa, CA in 1995 

• Why was the study done?

  • Tubal sterilization is the most prevalent form of contraception among married women and formerly married women in the US 

  • While sterilization was common, there was not widespread data about their efficacy, especially over time 

• Objective: To assess the effectiveness of various methods of tubal occlusion 

Methods: 

• Who was included? 

  • Prospective study of women undergoing tubal sterilization at the above mentioned medical centers from 1978 -1986 

  • Ages 15-44 years 

  • Patients were approached before their sterilization procedure 

• How was it done? 

  • If the patient agreed, information about her history was obtained 

    • Characteristics of the surgical procedure, including complications during the surgery and afterward, were recorded 

    • Contacted at 1 month for brief follow-up 

    • Annual follow-up planned for 5 years for all patients 

    • If they were enrolled early enough, patients also had annual followup for 8-14 years after sterilization 

    • If the patient could not be contacted for the follow up then the last completed interview was used in the analysis 

  • At the follow up, all patients were asked: “Since your tubal sterilization, have you had a positive pregnancy test or been told by a physician that you were pregnant?” 

    • If yes, the interviewer then had a separate form with additional info about the pregnancy 

    • Excluded from further follow up if they became pregnant, had a repeat sterilization, a tubal anastomosis, or hysterectomy 

  • Type of tubal occlusion included: (don’t need to say all of these) 

    • Laparoscopic unipolar coagulation - don’t do these anymore! 

    • Laparoscopic bipolar coagulation - I have never seen this 

    • Laparoscopic silicone rubber band application - I think I did a few of these 

    • Laparoscopic spring clip application - Filshie clips? 

    • Partial salpingectomy (including Pomeroy, other types of partial, and total salpingectomy) 

  • If a pregnancy was identified, they were classified into: 

    • True failure (pregnancy conceived after sterilization) 

    • Luteal phase pregnancy (pregnancies conceived before sterilization but ID’ed after) 

    • Pregnancy resulting from tubal anastomosis or IVF 

    • Or pregnancy of unknown status (didn’t get the information) 

Results 

• Who: 

  • 10,863 women enrolled → 178 were excluded from analysis

    • Some were due to loss to follow up, refusal to be interviewed at 1 month follow up, or refusal for prolonged follow up 

    • Others excluded because of hysterectomy, repeat tubal ligation, or death  

  • Demographics 

    • Median age: 30 (so pretty young!) 

    • Most women were non-Hispanic White (52.7%) and had had at least 2 pregnancies 

    • Most common procedure: silicone band (31.2%), followed by bipolar coagulation (21.2%), postpartum partial salpingectomy (15.3%)

      • For us, that is super different! Since I think what i have done the most is postpartum or interval total salpingectomies 

      • Though for a bit, we also did Pomeroys and Parklands  

• Follow-up 

  • 89.2% were interviewed at 1 year after sterilization, 81% at 3 years, 73% at 5 years, and 57.7% 8-14 years (so some drop off, but that’s expected) 

  • At each follow up interval, younger women (age 18-27) had lower percentage of follow-up than older women 

  • Black, non Hispanic women also had lower rates of follow up compared to white non-Hispanic women 

• Sterilization failures

  • Out of 10,685 women in the analysis, only 143 were true sterilization failures = 1.3% failure rate  

    • 21 (14.7%) ended in SAB 

    • 26 (18.2%) were TABs 

    • 41 (28.7%) ended in delivery 

    • 47 (32.9%!!!) ended in ectopic pregnancies 

  • Another 34 women not included in analysis had luteal phase pregnancies  

  • 16 were from tubal anastomosis and IVF, and 5 were “unknown” classification

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• Above table: lifetime accumulation of sterilization failure by method from 1-10 years per 1000 procedures and 95% CI (only showing years 1-4 because all the years made the table huge) 

  • We can see that for clip and interval partial salpingectomy, there seems to be a higher rate of lifetime pregnancies 

  • Lowest risk was postpartum partial salpingectomy 

• Also looked at 10-year cumulative probability of failure is affected by age at tubal sterilization 

  • Probability for failure in women <28 is greater than for women sterilized at ages >34 (makes sense … if you’re younger, you likely have more “fertile” years ahead of you) 

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• After adjustment for age, race, and study site, interval partial salpingectomy, spring-clip application, and bipolar coagulation were more likely than postpartum partial salpingectomy to result in sterilization failure 

• After adjustment, black women were at higher risk than white women for sterilization failure 

• There were also interestingly differences between sites! 

So what did this all mean? 

• Sterilization failure rates 

  • Higher than previously thought! For all comers it was a little over 1% 

  • HIgher failure rates occurred after longer times (ie. more than 1-2 years, which was what other studies had looked at)

    • Failure rates between 5-10 years after procedure ranged from 1.2-8.3/1000 procedures depending on method 

  • Method failure rate also is affected by age, race, and also institution! (meaning how well or properly you do the procedure could affect effectiveness) 

  • Also, risk of ectopic increases with tubal ligation 

• What was the follow-up or impact of the CREST study? 

  • There was way more data collected than just this, and way more than just this study that was published from the CREST dataset 

  • Some other studies that were interesting: 

    • Risk of regret after tubal sterilization (1985) - 2% regretted after 1 year, 2.7% did so after 2 years 

      • Characteristics of those that had more regret: age <30 (regardless of parity), concurrent C/S

        • After 5 year follow up, risk of regret in those 20-24 was 4.3%, rate for those 30-34 was 2.4% 

        • Where do we get this 20% risk of regret from??? - different study from 1999 - in women <30 years of age 

          • In that same study for women >30, risk of regret was 5.9% 

          • Also, for women <30 the cumulative probability of regret decreased as time since birth of the youngest child increased

          • Risk of regret was actually lowest for women with no previous births!!

    • Unintended laparotomy associated with laparoscopic tubal sterilization: rate was: 51/5021, so about 1%

      • Increased risk: prior abdominal or pelvic surgeries  

    • Characteristics of those that sought tubal reanastomosis

      • 6.2% sought information for reanastomosis 

      • Women who were <30 were more likely to seek out this information 

      • Of those that actually had anastomosis, they were more likely to be white, have lower gravidity, and be younger, and to have experienced changes in marital status

• How does this change our practice? 

  • We are performing different procedures from the ones that were studied in the CREST procedure

    • Nevertheless, I still quote the findings from this study for patients when they want them: 

      • Risk of failure depends on method

      • Risk overall of failure is low, but can be as high as 1% overall, and even higher depending on age and type of procedure 

      • Risk of conversion to laparotomy from laparoscopy is overall low but increases with more surgeries in the belly 

      • Risk of regret is as high as 20% – I think I may now qualify this only for certain populations! 

    • We shouldn’t NOT perform sterilization procedures, however, just because of risk of regret 

      • Even if someone is nulliparous, young, and not married, if they are well counseled and still desire sterilization, we can perform it