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 

Updates on Gestational Diabetes Screening

We last talked on the podcast about gestational diabetes with Dr. Coustan very shortly after we began in December 2018. Those podcasts are so good, and feature the man himself who is co-credited with the “Carpenter-Coustan” criteria we all know…

But if you’ve been watching journals recently, you probably have seen a lot of interesting papers with respect to GDM screening. So today’s episode will be a bit of an update on part one of those past GDM podcasts! Treatment fortunately hasn’t changed much so we won’t update that part today.

By the way – ACOG PB 190 on Gestational Diabetes Mellitus is still an excellent read!

Physiology of Insulin Resistance in Pregnancy 

• Progesterone effects on insulin resistance

• Normally, insulin binds to insulin receptor → phosphorylation of beta-subunit of receptor and leads to phosphorylation of the insulin receptor substrate I (IRS-I) 

• Progesterone reduces expression of IRS-1  

• Human placental lactogen effects on insulin resistance

• Both insulin-like and anti-insulin effects 

• Generally decreases maternal insulin sensitivity

• Decreases maternal glucose utilization

• Increases lipolysis and free fatty acids

• This allows for free fatty acids to become available for mother’s metabolism (do not cross placenta) so fetus gets glucose preferentially

• On the fetal side, exposure to hyperglycemia:

• Leads to increase in its own endogenous insulin production and production of insulin-like growth factor 1

• These lead to increased growth, fat deposition, and risk for macrosomia.

Prevalence and classifications of diabetes 

• Prevalence - hard to know b/c not everyone is tested

• 2009: 7% of pregnancies were in people with diabetes.

  • 86% of these cases were GDM  

• Classification: The White Classifications

• Depending on where you are, you may still see these in use; they are also helpful in classifying pre-gestational diabetes.

• Named for Dr. Priscilla White, who developed the schema in the 1950s and 1960s

• Class A1: diet-controlled GDM

• Class A2: medication-controlled GDM

• Class B: onset at age 20 or older or with duration of less than 10 years

• Class C: onset at age 10-19 or duration of 10–19 years

• Class D: onset before age 10 or duration greater than 20 years

• Class E: overt diabetes mellitus with calcified pelvic vessels

• Class F: diabetic nephropathy 

• Class H: ischemic heart disease

• Class R: proliferative retinopathy

• Class RF: retinopathy and nephropathy

• Class T: prior kidney transplant

Complications of GDM - ie. Why do we care? 

• Maternal complications

• High risk of developing preeclampsia, undergoing C/S

• Increased risk of developing type 2 diabetes later in life (up to 70% of patients with GDM develop T2DM within 22-28 years after pregnancy) 

• Fetal complications

• Increased risk of macrosomia, neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia and birth trauma 

• Increased risk of stillbirth 

• Fetal exposure to maternal diabetes may contribute to adult-onset obesity and diabetes in offspring 

Screening for GDM - The Basics 

• Used to be medical history and past obstetric outcomes and family history → fails to get 50% of patients with GDM 

• All pregnancies should be screened between 24-28 weeks of gestation, with one of two strategies:

• Two Step:

• 1973: O’Sullivan et al - described a 1 hr GTT with 50g of glucose  

• Carpenter-Coustan criteria: positive if >/= 130 mg/dL, though some institutions use 140 mg/dL

• If screened positive, should get a follow up test with 3hr GTT (100g)

• Diagnose if 2 abnormal values 

• However, even 1 elevated → increased risk of adverse perinatal outcomes compared to those without GDM or elevated values

• Carpenter-Coustan: Fasting: 95, 1 hr: 180, 2 hr: 155, 3 hr: 140  

• Alternative criteria (not in wide use): National Diabetes Data Group: 105, 190, 165, 145 

• One-Step alternative screening: International Association for the Study of Diabetes in Pregnancy Group (IASDPG) method:

• 75g 2hr test - just one test!

• Fasting: 92 mg/dL, 1hr: 180 mg/dL , 2hr: 153 mg/dL 

• If > 1 elevated = GDM

• “Early GDM screening” to look for early gestational diabetes  should be considered in some patients with risk factors.

• The best test to use for early screening is up for debate, however:

• Some might consider A1c, but because of new red cell generation / faster turnover in pregnancy, may artificially lower the A1c

• Some consider using an OGTT, but then it might be hard to convince patients to do it again if they screen negative.

• Some might consider a trial of “glucose profiling” with a glucometer but not any rigorous testing done about this.

View fullsize

ACOG PB 190

Updates in the World of GDM Screening:

• What’s better: two-step Carpenter-Coustan style, or one-step IASDPG style?

• In the last year, two randomized trials (NEJM, AJOG) and a systematic review/meta analysis (Green) have been published to help answer this question. 

• Because findings are similar, summarized from the meta-analysis:

• Patients with one-step screening are more likely to be diagnosed with GDM (16.3% vs 8.3% in the meta-analysis)

• Patient with one-step screening are more likely to be started on medications (7.1% vs 3.8%)

• Patients undergoing one-step screening were more likely to have NICU admission (5.1% vs 4.5%)

• Patients undergoing one-step screening were more likely to have babies experience hypoglycemia (9.3% vs 7.6%)

• Rates of LGA  babies are similar between strategies (8.8% one step, 9.2% two step)

• Rate of primary cesarean delivery was similar between groups (24.0% one step vs 24.7% two-step).

• What can we conclude from this?

• One-step testing seems to lead to increased resource utilization (more diagnoses, more folks on treatment, more NICU admissions)

• One-step testing does not appear to differ from two-step testing for some maternal short-term outcomes (LGA, cesarean delivery rate) or fetal outcomes (did not cover above but shoulder dystocia, RDS, stillbirth, neonatal death were all similar between groups)

• We don’t have any significant evidence about long-term outcomes for mother or fetus (i.e., later-in-life diabetes diagnoses, obesity rates in offspring, etc.)

• An editorial about the meta-analysis makes the case that one-step testing might still be cost-effective if the increased resource utilization means fewer downstream consequences… remains to be seen and tough to study!

• Early GDM screening: do we have anything new?

• Since our last podcast, there have been two US-based RCTs about this (Roeder, Harper)

• In the Roeder paper, patients with an A1c of > 5.7% or fasting glucose of > 92 were randomized to hyperglycemia therapy and nutritional counseling at the time of enrollment (early pregnancy) vs usual timing (3rd trimester)

• The study was ended early due to poor enrollment, but:

• Treatment in early pregnancy didn’t improve maternal or neonatal outcomes, including fat mass, weight percentile, macrosomia, or maternal weight gain.

• Treatment also didn’t significantly reduce the diagnosis rate of GDM at a usual-timing screening test (14.2% early treatment vs 25.8% usual treatment, p=0.17)

• In the Harper paper, obese patients (BMI > 30) were randomized to a traditional two-step test in early pregnancy (14-20 weeks) versus traditional timing.

• Those who screened negative early were also re-tested at traditional timing.

• Early screening did not reduce a composite perinatal outcome, nor did it seem to affect other important secondary outcomes.

• What can we take away from these papers?

• We still have a ways to go on proving the value of the “early GDM screen,” particularly of doing multiple glucose challenge tests.

• Guidance before the 1st step of the two-step approach:

• One common patient question is whether fasting or eating anything in particular might make one more likely to “screen in” on the 50g, 1h OGTT.

• In the January 2023 Green Journal, a group at Stanford randomized patients to a 6-hour fast prior to the 1hr test, versus eating within 2hr of the OGTT.

• The “fed” group actually had a lower rate of screening positive (13%) versus the “fasting” group (31%).

• Ultimately, the incidence of GDM was also higher in this “fasting” group (12.4% vs 5.1%). 

• The group theorizes this is due to a phenomenon previously called “starvation diabetes,” in which fasting leads to an increase in glucagon and decrease in insulin, thus making one transiently glucose intolerant; and then later, insulin kicks back in and returns you to a normal metabolic state. 

• This study only had about 100 individuals per arm of the trial, so hard to draw conclusions about neonatal/obstetrical outcomes, but none different in what they were able to assess.

• What can we take away?

• Hard to know totally, but probably don’t encourage fasting prior to the 1hr OGTT!

Surgery: Postpartum Sterilization Techniques

What is a postpartum tubal? 

• Procedure done after birth of a baby to permanently prevent future pregnancy 

• Reason for performing it postpartum:

• Usually done within 1-2 days after vaginal delivery 

• Highly effective: risk of pregnancy is <1% (though if you want to look at the actual rates depending on type of surgery, please check out the CREST study!

• Increased access: patients are already in the healthcare setting after delivery of their baby; don’t have to come back to the hospital/healthcare setting for a different procedure

• Mostly minimally invasive: not laparoscopy, but can be done through a single, mini-lap incision below the belly button as the fundus of the uterus is still high 

Today we will focus on the surgical steps 

• For pictures, we still like Atlas of Pelvic Surgery:

• In general for sterilization surgery

• Pomeroy technique

• Pre-operative 

• Surgical consent 

• Review the way the procedure is done and discuss the different methods that you can provide.

• Discuss the risks, benefits, and alternatives

• Benefits: stated above, quick recovery usually 

• Risks: as with all surgeries, there are risks of bleeding, infection, injury to organs around the uterus and fallopian tubes 

• Another big risk I tell people: we can’t perform the surgery that they want after delivery 

• A few major reasons: significant anemia after delivery, infection (ie. chorio/endometritis), inability to palpate the fundus after delivery 

• Can also be an issue for patients with increased central adiposity 

• Lastly, it is possible that we enter the abdomen but cannot perform the surgery because we can’t find the tubes, usually due to adhesions 

• Alternatives: no sterilization procedure or use a different form of birth control until 6 weeks postpartum for a laparoscopic procedure 

• MA-31 - 30 day consent! For those with state insurance

• Preoperative work up 

• History: 

• Ask specifically about history of abdominal surgeries and pelvic infections (ie. Chlamydia/Gonorrhea) 

• This can help determine if there will be significant intrabdominal adhesions that may prevent surgery 

• Not a strict contraindication for surgery, but should go into counseling of patients 

• Physical 

• Palpation day of surgery of the fundus 

• Can decide to proceed or not if fundus is easily palpable 

• No additional work up usually beyond prenatal care and delivery 

• Sometimes, if there is significant blood loss with delivery, providers may want to get a CBC 

• Usually, will have a type and screen on file already as patients are admitted for delivery (but should have this definitely)

• Anesthesia 

• Most procedures are done with neuraxial anesthesia 

• Sometimes, patients can keep their epidural from labor/birth 

• However, some patients may not want another epidural/spinal 

• Expectations 

• Patient will not need to necessarily stay longer than for delivery 

• May need a small amount of narcotic medication for incisional pain, but usually, I do not prescribe more than 5 tabs of 5 mg oxycodone, and only if needed 

• During the surgery 

• Adequate anesthesia and prepped and draped 

• Positioning: 

• Dorsal supine 

• Though during surgery, we can ask the anesthesiologist to airplane the patient to the left or right in order for the uterus to fall to one way or the other and bring the fimbria of the tube into view 

• Surgical steps 

• After prepping the abdomen, mark approximately 3-4 cm on the inferior edge of the umbilicus 

• Some people will inject 1% lidocaine at this time, but I find that it distorts the anatomy 

• Incise along edge and continue downward dissection until the fascia is reached. Can use Army-Navy or other retractors to hold back the skin 

• Pick up the fascia with either Kelly, Kocher, or Allis and make a small incision with the Metzenbaum scissors after ensuring no bowel is adhered to the fascia 

• Incise the fascia after protecting with a finger, and place a Kocher on either end. Some people will also throw a stitch on either end with an 0-vicryl and hold these with hemostats to be able to find your fascia later 

• Retract the fascia (again, can use army-navies or some people like the small Alexis-O retractor) and pop into peritoneum, then use a finger to feel for the cornua and tube 

• Can airplane the patient right or left for either tube 

• Once the tube is found, use a Babcock to hold it up and follow it out to the fimbria. Make sure it is a tube and not a round ligament! 

• Salpingectomy

• Use a Ligasure to clamp, seal, and cut the tube along the mesosalpinx 

• Make sure to hug the tube 

• Clamp, seal, and cut where the tube meets the cornua to remove the tube 

• Inspect area of sealing and cutting to ensure no bleeding 

• Allow the tube to fall back into the abdomen, and proceed with the next tube 

• If you don’t have a Ligasure, can use a kelly clamp to clamp along the mesosalpinx below the tube. Cut above the Kelly clamp until the end of the clamp is reached 

• Use a 3-0 synthetic absorbable suture and take a bite with the needle just beneath the level of the clamp and tie this portion down 

• Do this several more times until the cornua is reached 

• Use the Kelly clamp to clamp off the end of the tube, cut off the tube, and again, use the 3-0 synthetic absorbable suture to ligate the end of the tube 

• Send tube to pathology for confirmation of cross section

• Pomeroy Technique

• Place the babcock in the middle of the tube so that a small, 1-2 cm portion of tube is elevated 

• Tie a 3-0 synthetic absorbable around the base of this elevated section. Can tie two for a modified pomeroy 

• Hold the suture with a hemostat and then excise the knuckle of tube for pathologic confirmation 

• Use the hemostat to keep the tube out of the abdomen to inspect the area that you have incised for any bleeding. Use a bovie to coagulate any areas of bleeding

• Once the area is dry, can take off the hemostat and let the tube drop back into the abdomen 

• Parkland technique

• Place the babcock in the middle of the tube so that a small, 1-2 cm portion of tube is elevated 

• Using the Metzenbaum scissors, incise a small, avascular portion of the mesosalpinx beneath the babcock 

• Pass two ligatures of 3-0 synthetic absorbable suture through the area that was incised and tie down on either end of the tube

• Hold one end with a hemostat 

• Use the scissors to incise the knuckle of tube above the ligatures and send to pathology 

• Inspect the incised portions and ensure no bleeding

• Allow the tube to fall back into the abdomen 

• Once you have completed both sides and achieved hemostasis, close the fascia with 0-Vicryl or similar suture 

• Then close the skin with 4-0 Biosyn/Monocryl 

• Can inject lidocaine at this time if desired 

• Bandage the area with small pressure dressing 

• Post operative 

• Spinal/epidural should wear off before going to postpartum unit 

• Can breastfeed immediately if desired 

• Routine postpartum in the hospital, with small amount of narcotics if needed

• Remove dressing in 24 hours  

• Follow up for routine postpartum care 

Updates in Student Loans, feat. Michael Foley

We’re back once again with Michael Foley to talk updates in the student loan sphere on today’s #WellnessWednesday. We thank again the partnership from SMFM Thrive to make these podcasts possible!

Michael is a comprehensive financial advisor who runs his practice out of Scottsdale, Arizona, under North Star Resource Group. Michael was trained at Duke University and holds his Certified Financial Planner designation alongside his Certified Student Loan Professional designation. Although Michael serves a diverse group of clients with their financial and student loan needs, with two physician parents, Michael has found a specialty in working with those in the healthcare space.  Michael is a registered representative and investment advisor representative of Securian Financial Services. Securities and investment advisory services offered through Securian Financial Services, Inc. Member FINRA/SIPC. North Star Resource Group is independently owned and operated. 6720 N Scottsdale Rd Ste 290, Scottsdale, AZ 85253. “

Miss the PSLF Waiver? There may be another option after July 2023.

o   Must be employed at a qualifying employer at the time of your application for forgiveness though.

o   Can still get retroactive credit for periods of time with FFEL loans or while in certain period of forbearance/deferment.

o   Must consolidate prior to May 1st, 2023 though if there are FFEL loans involved.

New guidelines around PSLF qualifying month, starting July 2023

o   Things needed to get PSLF credit:

§  1. Working at a qualified employer,

§  2. making eligible payments,

§  3. for 120 months. These stay the same but the definitions of the first two have updates.

o   Eligible payment changes

§  Borrowers can now make retroactive payments to get credit for periods of time that they were in deferment or forbearance in the past and get them counted towards PSLF. Even periods of time where their payment would have been $0.

§  New consolidation rule: Weighted average of months.

·       Example: 1 loan 30k with 60 months combined with another loan with 30k with 0 months. New month count for consolidated loan will be 30 payments.

o   Changes to Qualifying employment

§  Flat 30hrs per week at a qualifying employer.

§  Allow qualifying employers to certify employment for a contractor if that individual is providing services that by State law cannot be filled or provided by an employee of that organization. Doctors at nonprofit hospitals in California and Texas.

Biden Forgiveness Update

Stuck in court after being struck down by a federal judge in Texas. Will likely be seen by the Federal Supreme Court which could take some time! Supreme Court will start the first oral hearings in February 2023. 

Forbearance period extension pushed out contingent on the court case:

·       Recertification dates extended

o   If falls 6mo after the loans turn back on, it will be pushed out by 1 year.  

·       Consult your CPA – a tax filing extension might be favorable on the student loan side of things if your 2021 income was lower than 2022.

Other meaningful updates in the Federal Student Loan space

Actions/Considerations:

1.     Don’t rule out the PSLF program even if you are a contractor with a hospital in CA or TX

2.     Consider consolidating any outstanding FFEL Loans prior to May 2023.

o   But be careful in consolidating all your loans (new weighted average rule).

3.     Don’t recertify income prematurely (given recertification extension)

o   Also, think before you file your taxes in the new year. Be sure to consult the CPA AND the student loan counselor if you made more in 2022 than in 2021. Potential for savings when payments do turn back on.

4.     Hold on changing repayment plans until after July 2023 if there is a lot of unpaid interest.

5.     Keep an eye on this court case- BUT remember that this is entirely separate from the PSLF program. Many are getting these confused.

6.     Be VERY careful with refinancing loans right now given the changes in the Federal space. Once you jump ship, you can never go back.

Additional Resources:

Bio: https://www.northstarfinancial.com/advisors/michael-foley/

https://www.ed.gov/news/press-releases/education-department-announces-permanent-improvements-public-service-loan-forgiveness-program-and-one-time-payment-count-adjustment-bring-borrowers-closer-forgiveness

https://www2.ed.gov/policy/highered/reg/hearulemaking/2021/futureofpslffactsheetfin.pdf?utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=

Contact:

FoleyTeam@NorthStarFinancial.com

Like to schedule a review of your student loans?

1. Please complete this BRIEF QUESTIONNAIRE (takes about 5 minutes).

2. Please also send a copy of your Federal Student Loan data file from www.studentaid.gov (instructions at the top of the questionnaire). Email: FoleyTeam@northstarfinancial.com

3. Scheduling link will be emailed following your completing the questionnaire.

Babies on a Plane: Air Travel, Pregnancy, and In-Flight Emergencies

Depending on your perspective, the idea of delivering a baby on a plane might be exciting… or your worst nightmare! Today we’ll talk about what to think about in this scenario, and familiarize you with what you have available for this in-flight emergency.

First of all… what recommendations are there for air travel (i.e., can we prevent this??)

• There is an ACOG Committee Opinion on Air Travel During Pregnancy (reaffirmed 2019)

• Highlights:

• Air travel is safe for pregnant folks, and there’s no increased risk of adverse events following occasional air travel.

• Most airlines will allow for air travel up until 36 weeks.

• The Points Guy blog had a recent post comparing airline policies, if you’re interested! 

• If travel is necessary after 36 weeks, most airlines will require a doctor’s note clearing the patient to fly.

• Remind patients traveling to reduce VTE risk with compression stockings, frequent movement/ambulation (at least 1x/hr), and adequate hydration.

• Risk of radiation for occasional air travelers is fairly minimal.

How common is the scenario of a birth on a plane?

• It’s not very common – but also hard to find estimates.

• One publication estimated a birth once in every 26 million air travelers. 

So if I’m on a 1 in 26 million flight… 

• First – we’ll plug a paid app called AirRx that’s written for physicians to know about what in-flight emergencies are common, and what you can expect to have access to in a flight.

• Information is destination/origin specific, so also useful for international air travel.

• We’ll focus on US-origin (mostly domestic) flights.

• Every flight has first aid kits:

• If under 50 passenger seats, minimum 1 kit.

• If 51-150, minimum 2.

• If 151-250, minimum 3 - this is a Boeing 737 size.

• If 251+, minimum 4. 

• First aid kits on planes have some basic equipment, including antiseptic swabs, bandages, adhesive tape, and bandage scissors.  

• Separately, all commercial aircraft in the USA are required to carry a separate “emergency medical kit” that contains more advanced equipment:

• Stethoscope and BP cuff

• Airway supplies

• PPE for you (gloves, gown, etc).

• IV tubing set with at least 500cc bag of NS 

• Tylenol, benadryl, aspirin

• Epinephrine, nitroglycerin, and atropine

• Automatic external defibrillator

• And some basic instructions for use of drugs in the kit.

• You will also have access to oxygen and masks.

Who can help?

• It’s good to keep in mind you have a team, and you’re never alone if you’re helping the crew respond to an in-flight emergency.

• Always share with flight crew yourself, your level of training, and show a medical ID if you have it.

• If someone has already volunteered, don’t be shy about volunteering, too – you never know who might have good skills to assist (especially if you’re an OB on a plane where a baby might be coming!).

• Also if you’re the only one who has responded – feel free to ask the crew to keep asking for additional assists if you need more folks to help.

• On board, you’ll have a flight crew:

• Ask them to bring the emergency medical kit and first aid kit.

• Ask one flight attendant to be an assist throughout the event (usually one will be assigned).

• The crew will notify a ground medical support team, who is well-trained in a wide variety of scenarios as well as specific physiology of flight.

• Talking to your ground medical crew:

• Be explicit about your impression of what’s going on.

• Keep what you say simple.

• Keep talking and keep everyone informed – your pilot and crew are often trying to help with weighing a decision about whether emergency landing is warranted.

• This is more than the medical decision – part of this is airport choice, whether the plane is safe to land (i.e., is the extra fuel of landing early making the plane too heavy for a safe landing), and whether resources are available to assist the patient where landing is considered.

• Especially if there is concern for communicable disease, flight crew needs to be aware for themselves and to alert ground medical crew for transport considerations.

• Be professional – all conversations with medical ground crew are recorded!

Starting your assessment

• Get basic vitals - vital signs are vital!

• Get your history.

• Do what you do best as an OB – assess labor or not in labor!

• You are limited in the air - you have your physical exam, and that’s about it.

• Your goal is to promote safety of the patient and passengers with your professional assessment. 

• You’ll have assistance from ground medical staff on what to do in specific scenarios regarding flight diversion.

• Pregnant folks also have a lot of other things that can be occurring – keep your differential diagnosis broad and reassure folks if labor is not occurring. You may be the best person to limit panic in assessing a pregnant person on board a plane, regardless of the complaint.

• If delivery is occurring, get help!

• You know you need assistants, even if not trained.

• Be prescriptive and talk out loud – think about how you simulate a shoulder dystocia. Now imagine that on a plane with no nurses, no backup, no anesthesia – you have to be directive in making sure you get what you need to succeed.

What about weird / crazy / undesirable scenarios in the air?

• Preterm labor:

• Remember these babies need breathing and warmth primarily!

• In your emergency medical kit, you have equipment for PPV and oxygen that can be administered to babies.

• Skin-to-skin, layers, and blankets are readily available on planes for warmth.

• For super premature kids, we often will put them in plastic bags to help with heat retention… and on planes, there’s often several of those! Ask for a gallon Ziploc bag from volunteering passengers.

• Malpresentation (i.e., breech or cord prolapse).

• Don’t encourage pushing in these scenarios! Be clear with ground crew an emergent cesarean is needed and landing the plane needs to be a top consideration. 

• Get patient into all fours for a cord prolapse, with chest down and butt up – this will help presenting parts stay off the cord.

• If the baby is coming – go through our breech delivery episode and simulate breech deliveries while you can in training! 

• Postpartum hemorrhage

• You’re limited in what you can do here – bimanual massage, examination, pressure, and bandages. 

• You have a limited amount of IV crystalloid on a plane you can give. 

• Remember that nipple stimulation can help with oxytocin production – starting breastfeeding or doing nipple stim can get the uterus contracting.

• Consider delaying placental delivery until the plane is landed – remember you have 30 minutes in an active management scenario. If there’s no active bleeding and baby is delivered, without oxytocin, it may be prudent to wait to not provoke bleeding.

What about medicolegal implications?

• There is no relevant international law for assisting in-flight medical emergencies.

• In the US, the Aviational Medical Assistance Act (aka, “Good Samaritan Act”) of 1998 states:

• An individual shall not be held liable for damages in any action brought in a Federal or State court arising out of the acts or omissions of the individual in providing or attempting to provide assistance in the case of an in-flight medical emergency, unless the individual, while rendering such assistance, is guilty of gross negligence or willful misconduct.

• The standard for malpractice here is significantly higher than it is in usual malpractice cases.

• There is no example of a medical professional anywhere in the world who has been sued successfully for assisting an ill traveler

• Actually - successful lawsuits have only occurred against airlines; and airlines will normally accept liability associated with requests for in-flight assistance. 

• There likewise is no standard protocol for documentation of in-flight events and assistance; but individual airlines may have forms or policies.

• It is advisable for you to create a secure document of your exam, assessment, and plan, or get a photo of a completed airline documentation form, for your own records in case you are asked to comment on the case later for any reason.

What about compensation?

• The Good Samaritan law only applies to true “good samaritan” actions, so where no compensation is provided. Because of this, it’s not advisable to take any monetary compensation for assisting in an in-flight emergency.

• These laws do not address non-monetary compensation (i.e., frequent flyer miles, seat upgrade, bottle of wine, etc.). 

• However, just because they are not addressed doesn’t mean they may not be targeted, so most folks advise not accepting these gifts.

• Lawsuits have been brought against assisting physicians; just none of them have succeeded in US courts to date.

Final Fun Facts

• If a baby is born in flight, most of the time the child is given citizenship status of the parents.

• If in US airspace, the child can also be given US birthright citizenship.

• Sometimes, citizenship is awarded based on the country of registration of the plane.

• The most recent baby we could find born on a plane occurred in Oct. 2022:

• American Airlines flight from NYC to the Dominican Republic!