#MedEd: Introduction to Contract Negotiations

It’s been a while since we did our last #MedEd Wednesday release, but our friends over at Eyes For Ears (the CREOGs Over Coffee equivalent for ophthalmology) just released an excellent episode on contract negotiations featuring Heidi Mason, JD, an employment lawyer. The lessons here cut across specialties so we thought it was important to bring to you all — and to hear some fresh voices on the show ;)

Second Trimester Abortion

Second Trimester Abortion: Legal Issues

  • In the US, 1.2 million abortions occured in 2008.

    • Of these, approximately 10% took place after 13 weeks, with more than half occurring between 13 and 15 weeks. 

    • Only 1.3% of abortions are performed at or after 21 weeks gestation.

  • There are varying state-level statutes that may limit the gestational age for obtaining an abortion, or the type of abortion treatment that can be offered.

  • The Guttmacher Institute maintains an overview of abortion laws by state. Some highlights from them:

    • 43 states have gestational age limits on when abortion can be performed. These range from 20 weeks to viability, with some statutes currently being challenged in court that could restrict access as early as 6-15 weeks.

    • 21 states prohibit “partial-birth” abortions, which is a misnomer that we will explain momentarily.

      • 2 states have standing bans on standard dilation and evacuation (Mississippi and West Virginia), with an additional 9 having some enjoinment on enforcement of a ban on D&E. 

    • 26 states require waiting periods between counseling and a procedure. 18 states require specific counseling which may include false or misleading information on:

      • Link between breast cancer and abortion (5 states).

      • The ability of a fetus to feel pain (13 states).

      • Long-term mental health consequences of abortion (8 states).

Methods of 2nd Trimester Abortion

Dilation and Evacuation

  • Use of medication or mechanical techniques to dilate the cervix, followed by the use of grasping forceps to remove the fetus.

  • Most commonly achieved with osmotic dilators in combination with misoprostol for cervical ripening.

    • The success of cervical preparation at 18 weeks gestation and above may be improved with the use of mifepristone the night prior to the procedure in combination with osmotic dilators.

      • However mifepristone may also increase risk of pregnancy expulsion prior to the procedure, particularly if misoprostol is subsequently used for further dilation.

  • A variant of this technique is known by a variety of names such as “dilation and extraction” or “intact D&E,” in which further dilation is achieved which allows for removal of an intact fetus except for possible calvarial decompression. 

    • This has been labeled in some publications as partial-birth abortion and may be restricted to some degree in a number of jurisdictions. 

    • In order to avoid consequences associated with these laws, some experts advise preoperative feticidal injection with KCl or digoxin. 

Medical or Induction Abortion

  • Induction may also be used to achieve abortion, however this is less-cost effective, takes more time, and is more associated with complications.

  • Generally, this is achieved through similar techniques for cervical ripening to labor induction -- mechanical dilators or balloon catheters, misoprostol, and oxytocin. 

    • The most efficacious medical management is mifepristone administered 24-48 hours prior to misoprostol initiation, based on RCT evidence.

    • Osmotic dilators do not necessarily add benefit to misoprostol in this setting. 

  • Preoperative feticidal injection does not shorten the duration of induction, but may be used if preferable to the woman or provider to avoid transient fetal survival after expulsion. 

  • ACOG lists three primary techniques for medication abortion in the second trimester; ACOG and SFP note that the mife-miso regimen is the most efficacious for 2nd trimester induction abortion:

Hysterotomy or Hysterectomy

  • Abdominal surgery is rarely indicated for second-trimester abortion, but is occasionally indicated in the event other procedures fail or are contraindicated. 

  • A prior cesarean or uterine scar is not an indication for hysterotomy for abortion, or for the avoidance of misoprostol, at least up until about 28 weeks gestation.

    • Retrospective cohort studies have demonstrated an insignificantly increased risk of uterine rupture for women with one prior cesarean delivery around 0.28%, versus rupture risk for unscarred uteri around 0.04%.

      • There is insufficient data to guide management on women with 2+ CDs. 

    • However, this remains well below the established acceptable risk threshold with trial of labor after cesarean at term without misoprostol use (rupture risk for 1 prior CD at 0.5-0.7%). 

      • The risk of rupture is suspected to increase with misoprostol use at or after 28 weeks, based on TOLAC data.

Complications and Other Situations

  • Mortality is 0.6 / 100k legal, induced abortions, with that rate being tied to gestational age at the time of abortion.

    • At 21 weeks gestation or greater, the rate of mortality rises to 8.9 / 100k procedures.

    • Maternal mortality for live birth is 17.6 / 100k live births in USA (or double that for 21+wk abortion, by comparison).

  • Postabortion hemorrhage is defined as “blood loss > 500cc and/or bleeding requiring a clinical response such as transfusion or hospital admission.”

    • Rates of transfusion range from 0.1 - 0.7%, with higher rates seen for medical 2nd trimester abortion. 

    • Management is similar to hemorrhage after term vaginal delivery, ruling out retained products and uterine atony as primary causes.

      • Cervical laceration, uterine rupture, and abnormal placentation are also rarer but important concerns, particularly in more advanced gestational age and in women with prior cesarean delivery. 

  • Postabortion infection is uncommon, occurring in 0.1-4% of 2nd trimester abortions.

    • Antibiotic prophylaxis is indicated prior to dilation and evacuation.

      • SFP recommends 200mg doxycycline preoperatively.

      • The ACOG PB recommends use of 100mg doxycycline preoperatively and 200mg postoperatively

      • RCT methodologies on antibiotic use support solely preoperative antibiotic use as sufficient. 

  • Postabortion contraception placement in the form of IUDs additionally does not increase infection risk, but expulsion rates may be higher after abortion than with interval placement.

  • Reversible contraception of almost any kind (no diaphragms or cervical caps) can be initiated immediately post-abortion, and ovulation can resume as soon as 21 days post-procedure.

Medication Abortion

Epidemiology of Abortion

In 2017:

  • 60% of abortions occured prior to 10 weeks gestation;

  • Medication abortion comprised 39% of all abortions.

Medication abortion may be more attractive than procedural abortion because it can be done safely, effectively, and discretely, at the patient’s preference. 

Who is eligible for medication abortion?

Most patients at 70 days gestation or less are eligible for medical abortions. Patients with distorting fibroids, uterine anomalies, or scarring of the introitus due to FGM may benefit (versus aspiration). Multiple gestation is not a contraindication, and can use the same regimen as singleton gestations. 

Gestational age should be confirmed prior to initiating a medication abortion, by certain LMP within the past 56 days in patients with regular cycles and no symptoms or signs of ectopic pregnancy. Clinical or sonographic exam are not required before medication abortion.

Rh status should be verified, with RhoGam administered if indicated for Rh negative patients. Research here is continuing, but RhoGam is recommended by ACOG for all Rh negative patients. Some situations may call for shared decision-making on this front, and some institutions and professional groups do not recommend RhoGam prior to 10 weeks gestation. 

Additional laboratories, counseling, or evaluation may be required by local or state laws prior to proceeding with medication abortion.

Finally, medication abortion may not be an appropriate choice for patients: 

  • with suspected or confirmed ectopic pregnancies, 

  • patients with an IUD that remains in situ, 

  • patients with chronic medical conditions: 

    • long-term steroid use, 

    • coagulopathy or anticoagulation use, 

    • adrenal insufficiency.

    • Anemia or hemoglobinopathy: 

      • Transfusion rates are higher with medication abortion versus aspiration (0.1 to 0.01%); patients in this category may benefit from aspiration or closer monitoring but are likely reasonable candidates. 

  • Finally, patients should be willing to follow up completely and have good contact information, understand that medication abortion may take some time for completion, and be able to understand instructions to ensure success. 

Counseling:

Clear instructions on what to expect should be provided to patients who undergo medication abortion:

  • Bleeding and cramping, with bleeding much heavier than menses.

    • Bleeding heavier than two maxi pads per hour for 2 hours should prompt patients to contact their clinician.

    • Patients should be counselled that additional intervention may be needed in the event of excess bleeding or suspected failure; however this is rare (less than 1%, and transfusion rates less than 0.1%). 

  • Rate of ongoing pregnancy is low, and the risk increases at later gestational ages.

    • The risk of ongoing pregnancy at 64-70 days gestation is around 3%.

    • Teratogenicity is associated with the use of both mifepristone and misoprostol, so patients should be counseled about this in the event of medication failure, or if patients attempt to use high-dose progestins for unsanctioned “abortion reversal.”

    • There is no regimen that has been demonstrated to reverse abortion after administration of medications, and this has been shown in small studies to increase risk of complications.

  • Side effects of misoprostol use are commonly GI upset, hot flushes, fever or chills. Mifepristone is generally well tolerated with few side effects.

  • Risk of infection is overall very low, so there is no indication for antibiotic prophylaxis.

What medications are used for medication abortion?

There are a number of approved regimens, but the most successful and preferred is a combination of mifepristone and misoprostol.

  • Mifepristone is a selective progesterone receptor modulator.

    • Binds progesterone receptor with greater affinity than progesterone, but does not activate it, thus acting as an antiprogestin.

    • The provision of mifepristone in the USA is dependent on a “risk evaluation and mitigation strategy,” or REMS program, facilitated by the FDA. ACOG and other professional organizations oppose the ongoing use of the REMS program as it does not make care safer and creates a barrier to the most effective form of medication abortion. 

  • Misoprostol is a prostaglandin E1 analog.

    • Causes cervical softening and uterine contractions. 

The FDA approved combination is mifepristone 200mg orally, followed 24-48hrs later by 800 mcg of buccal misoprostol.

The WHO suggests misoprostol can be administered vaginally, buccally, or sublingually at the same dose and interval. 

Success rates range from 93% to 98% (lower success rate at more advanced gestational age). The rate of ongoing pregnancy in the highest gestational age range (64-70 days) was small at 3.1%. 

Misoprostol alone may also be used at 800 mcg vaginally, sublingually, or buccally, every 3 hours for up to 3 doses. However, mife-miso is a much more effective method and should be used if available. 

What clinical follow up is recommended after medication abortion?

Follow up can be performed clinically or remotely via telemedicine. Clinicians are able to successfully determine if pregnancy expulsion has occurred with 96-99% accuracy based on symptomatology alone. The use of pregnancy tests can also be a helpful adjunct to confirm expulsion, but are not absolutely necessary.

Sonography can be used as well, but may also predispose patients to additional unnecessary procedures. The measurement of endometrial thickness does not predict need for subsequent aspiration or complications. 

If abortion is suspected to be incomplete, the patient can be counseled about aspiration versus a repeat dose of misoprostol or expectant management. Surprisingly, studies have shown that even with a gestational sac is retained at 2 weeks after initial medication use, expulsion will usually occur spontaneously in the coming weeks! Ongoing symptoms such as irregular bleeding can persist in this case though, so many patients opt for intervention. 

What about contraception after medication abortion?

Most contraceptive methods are safe to start immediately or soon after abortion. Complete abortion should be ensured before placement of an IUD; usually a week after medication administration. 

Progestin-based contraceptives have a theoretical risk of interfering with mifepristone efficacy; this has been demonstrated with DMPA use on day 1 of the medication abortion, and thus patients should be counseled that risk of ongoing pregnancy may be greater in this scenario. This has not been observed with etonogestrel implants. 

Cardiovascular Disease in Pregnancy Part II: Classifications and Valvular Disease

There are multiple systems for the classification of cardiac disease in pregnancy:

  • Modified WHO Pregnancy Risk Classification - this scale is based on the presumptive risk of cardiac disease towards pregnancy outcomes.

    • Class I: no detectable increase in maternal mortality, and no or only mild increase in morbidity.

      • Ex: uncomplicated/small/mild pulmonary stenosis, PDA, mitral valve prolapse; successfully repaired simple lesions (PDA or septal defects); isolated atrial or ventricular ectopic beats

    • Class II: small increased risk in maternal mortality, moderate increase in morbidity.

      • Ex: unoperated ASD or VSD; repaired tetralogy of Fallot; most arrhythmias.

    • Class III: significantly increased risk of maternal mortality or severe morbidity. Recommended intensive specialist cardiac and obstetric monitoring throughout pregnancy, delivery, and postpartum.

      • Ex: mechanical valve, systemic right ventricle, Fontan circulation, unrepaired cyanotic heart disease, aortic root dilation 40-45mm in Marfan patient or 45-50mm in bicuspid valvular disease.

      • Some patients may fall into an in between II-III category (i.e.,m mild LV impairment, HCM, Marfan syndrome without root dilation).

    • Class IV: extremely high risk of maternal mortality or severe morbidity; pregnancy considered contraindicated with recommendation for termination if pregnancy occurs. If continues, manage with specialist involvement as per class III.

      • Ex: pulmonary arterial hypertension, severe systemic ventricular dysfunction (LVEF < 30%), previous peripartum cardiomyopathy with any residual LV dysfunction, severe mitral or aortic stenosis; aortic root dilation in Marfan syndrome > 45mm or >50mm in bicuspid disease; native severe aortic coarctation.

  • NYHA Functional Classification - likely a familiar scale, based off of cardiac disease symptoms and functional status.

    1. Class I - cardiac disease, but no symptoms and no limitations in ordinary physical activity 

    2. Class II - mild symptoms and slight limitations during ordinary activity

    3. Class III - significant limitation in activity due to symptoms. Comfortable at rest 

    4. Class IV - severe limitations. Symptoms even while at rest.  

  • CARPREG II or ZAHARA - point-based scales for risk prediction for a significant cardiac event in pregnancy:

Valvular Disease

  • Native Valvular Disease

    • Stenosis - the valve is narrowed or stiffened and does not allow for passage of blood.

      • Tricuspid stenosis - makes it hard for blood to pass from the right atrium into the right ventricle.

        • With increased cardiac output as well as increased systemic volume, stenosis of the tricuspid valve can lead to systemic overload (ie. swelling, JVD, etc); severe stenosis can make it so that less blood gets into the pulmonary system.

      • Pulmonic stenosis - blood is impaired in passage from RV to lungs.

        • In isolation, this is generally well tolerated since pregnancy provides additional volume, thus providing more blood to pump to the lungs in totality.

        • However, can be associated with other complex heart disease, in which outcomes are not as good.

      • Mitral stenosis - blood flow challenged from LA to LV.

        • Most common cause worldwide: rheumatic heart disease.

        • Increased CO and HR leads to decreased filling (diastolic) time. This promotes increased left atrial pressure and dilation, leading to atrial fibrillation, pulmonary edema.

        • Maternal mortality with severe MS is 3%.

        • Treatment in pregnancy is with beta blockers to decrease HR and increase filling time. Anticoagulation needed if atrial fibrillation develops.

      • Aortic stenosis - blood flow impaired from LV to aorta.

        • Most common cause: bicuspid aorta (congenital).

        • Pregnancy well tolerated except for patients with severe disease; need good flow systemically to accommodate increased cardiac output and stroke volume demand of pregnancy.

        • Severe AS can result in heart failure, arrhythmias, and pulmonary edema.

    • Regurgitation - insufficiency across a valve, allowing for backflow of blood.

      • Tricuspid regurgitation: overall well-tolerated, but higher risk of right-sided failure and atrial arrhythmia.

      • Pulmonic regurgitation: moderate or severe cases may lead to RV failure and arrhythmia.

      • Mitral regurgitation: usually well tolerated as long as there is absence of LV systolic dysfunction or pulmonary hypertension.

        • If severe, ideally valve is repaired or replaced prior to pregnancy.

      • Aortic regurgitation: also well-tolerated overall, unless signifiant baseline symptoms.

        • Risk of heart failure due to volume overload; can also occur alongside LV systolic dysfunction, severe LV dilation, or pulmonary hypertension.

  • Mechanical or Prosthetic Valves

    • There is an increased risk of thrombosis/VTE in pregnancy, and these patients will need to be on anticoagulation.

    • Warfarin is the preferred anticoagulant despite risk of embryopathy, as the risk of thrombus is higher on heparin or heparin-like agents.

Pearls on managing valvular disease in various stages of pregnancy:

  • Prepregnancy 

    • Depending on severity, may need have preconception counseling with cardiologist and MFM.

    • Patients with severe mitral and aortic stenosis may need balloon valvuloplasty beforehand.

  • During pregnancy 

    • Really, this is based on their cardiovascular risk score (ie. WHO classification) 

    • Most of these patients will need an echocardiogram during early pregnancy, and likely follow up at an interval depending on hemodynamic tolerance.

    • Evaluate and treat any symptoms of heart failure!

    • Labor and delivery: vaginal delivery is usually the preferred method of delivery unless: 

      • Mitral stenosis with NYHA class III/IV or have pulmonary hypertension 

      • Severe, symptomatic AS 

    • Especially with more severe symptoms, consider early epidural (especially in mitral stenosis) and assisted second stage.

    • Telemetry if risk for arrythmia exists.

  • After delivery 

    • For many of these lesions, need to reevaluate an echocardiogram.

    • Many of these patients, due to fluid shifts, are at higher risk for arrhythmias and heart failure after delivery.

    • Strict I/Os in the postpartum period!

    • Consider telemetry if risk for arrhythmia.

Cardiovascular Disease in Pregnancy Part I: Normal Physiology

Basic Heart Function

Right Heart

  • Blood flows from the SVC + IVC → R atrium → tricuspid valve (3 leaflets) → R ventricle → pulmonary valve (3 leaflets) → pulmonary artery (or pulmonary trunk), which then divides to right and left pulmonary artery → lungs.

  • What happens if the right heart fails?

    • R sided heart failure basically means that the right side of the heart is not pumping out as much blood to the lung that is coming in from the peripheral veins (blood in > blood out).

      • This leads to blood backing up into the systemic circulation → lower extremity edema, hepatomegaly, jugular venous distention.

      • One of the most common causes is left heart failure.

      • Other acute causes:: pulmonary embolism with large clot burden, adult respiratory distress syndrome, RV myocardial infarction, myocarditis.

      • Causes of chronic right heart failure: pulmonary hypertension, pulmonary arterial hypertension (which is different from PH!), COPD, OSA, congenital heart disease, cardiomyopathies, or right sided valve disease.

Left Heart 

  • Oxygenated blood from lungs → left atrium → mitral valve (2 leaflets) → left ventricle → aortic valve (3 leaflets) → aorta & systemic circulation 

  • What happens if the left heart fails?

    • Left heart failure again means that the left side of the heart is not pumping out as much blood to the body as is coming in (blood in > blood out).

      • This leads to blood backing up into the pulmonary circulation → pulmonary edema, which can lead to SOB, coughing, etc 

      • Causes of left heart failure: myocardial infarction, dilated cardiomyopathy, left sided valvular disease, hypertension, congenital heart disease 

How does the cardiovascular system change with pregnancy? 

Hemodynamic changes

  • Antepartum 

    • Throughout pregnancy, there is a continuous increase in maternal cardiac output and plasma volume.

    • There is a decrease in maternal systemic vascular resistance.

    • Blood pressure will decrease initially, but will increase in 3rd trimester.

  • Intrapartum and postpartum 

    • During labor and delivery, there is increase in cardiac output, heart rate, blood pressure, and plasma volume 

    • Immediately postpartum, there is a large fluid shift (500 cc of autotransfusion), as blood flow to the gravid uterus shifts back to maternal circulation 

    • Blood pressure may increase between days 3-6 because of fluid shifts 

    • All of these shifts will make women with cardiac disease more prone to fluid overload and pulmonary edema.

Structural changes 

  • The heart itself will increase in size with pregnancy 

  • The left and right ventricular mass increase by approximately 50 and 40% 

  • LV end diastolic volumes increase by 10% 

  • Approximately 20% of women have diastolic dysfunction at term → dyspnea on exertion 

  • Structural changes return to baseline after 1 year postpartum