Espresso: Zuranolone for Postpartum Depression

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We’re back! While we’ll operate for a bit on a reduced schedule (new episodes every-other-week), we are so excited to get back to podcasting and covering the need-to-know in OB/GYN. Thanks for all the love and support over the last few months! <3 Nick & Fei

Reading: Zuranolone for the Treatment of Postpartum Depression (ACOG Practice Advisory)

What is zuranolone and why is it important? 

    • We know that postpartum/perinatal mental health conditions and some of the leading causes of preventable maternal mortality 

      • PPD affects approximately 14% of women 

      • Understanding/discussing/recommending medication and treatment can potentially decrease maternal morbidity and mortality 

  • Medication type

    • Neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator 

    • Oral medication  

    • Recent FDA approval for use in PPD 

Why is zuranolone recommended, and what else is out there? 

  • Why is it recommended? 

    • Two phase 3 randomized double-blind, placebo-controlled multicenter studies 

    • Primary endpoint in both: change in depressive symptoms in the Hamilton depression rating scale (HAMD-17) 

      • 17 point scale 

      • Assesses somatic (physical ie. loss of appetite), affective (mood ie. sadness), cognitive (thinking, ie. difficulty concentrating), and behavioral (ie. social withdrawal) symptoms of depression 

      • Reliable and valid method of assessing and measuring depression 

    • In both studies, those on Zuranolone showed significantly more improvement in their symptoms compared those in placebo 

      • Treatment effect maintained at day 42 (4 weeks after last dose of zuranolone) 

  • Why the HAMD-17? 

    • More used in research settings, but anticipated that other validated tools (like EPDS or PHQ9) will be used in clinical settings 

  • What else is out there? 

    • Brexanolone - first FDA approved medication specifically for postpartum depression

      • However, unlike zuranolone which is oral, brexanolone consists of a 60 hour in-hospital IV infusion, which may not be readily accessible 

        • May be difficult to arrange inpatient admission 

        • May also be difficult for patients to leave their newborns for 60 hours to get infusion 

    • SSRIs 

      • Not specific for postpartum/perinatal depression 

      • Can be effective, but also may be difficult to find the correct SSRI

      • Many SSRIs also require uptitration of dosage 

  • What to consider when prescribing zuranolone 

    • Consideration of zuranolone in the postpartum period (within 12 months postpartum) for depression that has onset in the third trimester or within 4 weeks postpartum

    • Benefits: 

      • Significantly improved and rapid resolution of symptoms 

    • Risks: 

      • Potential suicidal thoughts or behavior 

      • Sedation - can make it so you can’t drive 

      • Lack of efficacy data beyond 42 days 

  • How to prescribe and take zuranolone 

    • Daily recommended dose is 50 mg 

      • Take in evening with fatty meal (400-1000 calories, 25-50% fat) for 14 days 

      • Can reduce dose to 40 mg if CNS depression effects occur 

      • If hepatic or renal impairment, start dose at 30 mg 

    • Can be used alone or as an adjunct to other oral antidepressant therapy like SSRIs 

    • Recommendation is to have effective contraception during treatment and for 1 week after final dose. There is a registry if pregnancy occurs 

    • Warn patients about adverse reactions 

      • Impaired ability to drive 

      • CNS depressant effects 

      • Increased suicidal thoughts and behaviors 

    • Zuranolone does pass into breastmilk, but relative infant dose is smaller than that of SSRIs 

Espresso: Cord Prolapse

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What is cord prolapse? 

  • Definition 

    • When the cord moves out of the cervix in front of the fetal presenting part; can usually only happen when rupture of membranes has occurred 

      • Otherwise, it is called funic presentation (cord presenting with intact membranes)

    • Uncommon: 1.4-6.2/1000 

    • Majority of them happen in singleton gestation, but there is an increased risk in twin pregnancies of the second twin 

  • Risk Factors

    • PPROM - especially if the fetus is not in the cephalic position 

    • Multifetal gestation 

    • Polyhydramnios 

    • Fetal growth restriction 

    • Preterm labor 

    • AROM when fetal head is not well engaged 

      • Nearly half of cases are attributed to iatrogenic causes 

      • 57% occur within 5 minutes of membrane rupture, and 67% occur within 1 hour of rupture 

  • Why do we care? 

    • Compression of the cord → vasoconstriction and → fetal hypoxia 

    • Can lead to fetal death or brain damage if not rapidly diagnosed and managed 

How can I recognize cord prolapse? 

  • Exam 

    • Palpation of a pulsatile mass in the vaginal vault or at the cervix 

    • No need for radiographic or laboratory confirmation 

  • Fetal heart tracing 

    • Usually can see recurrent variable decelerations or fetal bradycardia 

  • Differential diagnosis 

    • Another mass in the vagina could be fetal malpresentation 

    • Other causes of fetal bradycardia/decelerations should also be considered 

How do I manage cord prolapse if it is found? 

  • Reduction of the cord – if possible 

    • This is usually not possible if there is large amount of cord in the vagina, and not recommended 

    • However, if there is small amount of cord at the internal cervical os, at times, it is possible to reduce it back beyond the present part 

    • However, if there is recurrent prolapse … 

  • Expedient delivery

    • Usually via cesarean delivery 

    • Prior to getting to the operating room, the goal should be decompression of the umbilical cord 

      • Elevate the fetal presenting part as interval to umbilical cord decompression can be associated with worse outcomes than interval to delivery 

        • Decompression can be done manually: place finger or hand in the vagina and gently elevate the head or presenting part off of the umbilical cord 

        • Do not put additional pressure on the cord → can lead to vasospasm 

      • Another way of decompression 

        • Place pregnant patient into steep Trendelenburg or knee-chest position 

        • Usually if there is not a provider who is able to do manual decompression or if there is prolonged interval to delivery (ie. transfer to hospital) 

      • If there is visible cord protruding from the introitus, try to place a warm, moist sponge or towel over the cord to prevent vasospasm

        • Or can replace into vagina 

What are the outcomes, and how do I prevent prolapse? 

  • Prognosis 

    • Fetal mortality is <10% now that we are able to complete cesarean sections in a timely manner 

    • In earlier studies, the range was 32-47% 

    • Gestational age and location of prolapse (in or out of hospital) can significantly determine outcomes 

      • Cord prolapse outside of hospital carries 18x increased risk of fetal mortality 

  • Prevention 

    • For patients who are at increased risk of cord prolapse (ie. PPROM, malpresentation), they should be encouraged to deliver at a hospital 

    • Early recognition training by both patient and providers

      • SIM! 

    • ACOG recommend against routine amniotomy in normally progressing labor unless needed for fetal monitoring 

      • AROM - if needed, make sure that there is engagement of the fetal head 

      • If AROM is needed, but there is polyhydramnios or high fetal station, can use a fetal scalp electrode to rupture the amniotic sac to slowly release fluid 

Espresso: Uterine Rupture

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What is uterine rupture? 

  • Definition

    • Spontaneous tearing of the uterine muscles which can lead to expulsion of the fetus into the peritoneal cavity

    • In the literature, uterine rupture can also incorporate less catastrophic phenomena, like uterine window or asymptomatic scar dehiscence without expulsion of the fetus

    • Focus today: intrapartum uterine rupture.

    • The true incidence of uterine rupture across all populations in pregnancy is likely very low.

      • With no history of surgery, the risk is 1/8000-17,000 deliveries 

    • With one prior low transverse cesarean, the incidence has been reported to be between 0.2-1.5%, though usually quoted as <1% 

    • With two prior low transverse cesareans, the incidence is reported to be between 0.8-3.9%, usually quoted as just over 1% 

    • However, there are things that can modify this risk: 

      • History of prior successful VBAC → reduce the risk of rupture from 1.1% to 0.2% 

    • In other types of incisions such as T-incisions and classical incisions, the rate of rupture can be as high as 4-9%

  • What are some other risk factors? 

    • By far, the biggest one is previous uterine surgery,

    • Other risk factors: 

      • Uterine scar presence

      • Uterine anomalies

      • Prior invasive molar pregnancy

      • History of placenta accreta spectrum

      • Malpresentation

      • Fetal anomaly

      • Obstructed labor

      • Induction of labor with use of prostaglandins

        • These other risk factors are much less significant than prior uterine surgery/presence of scar  

How do I recognize uterine rupture?

  • Again — only be discussing uterine rupture in labor 

    • There are a few studies looking at thinning of the myometrium on ultrasound, but this is controversial.

    • It is much more likely that you will encounter uterine rupture at time of labor and birth than during other times 

  • Diagnosis

    • High index of suspicion - know your patient’s risk factors and be on the lookout for uterine rupture given how catastrophic it can be for both maternal and fetal wellbeing 

    • Some of the classical signs: 

      • Sudden, tearing uterine pain

      • Vaginal hemorrhage

      • Cessation of contractions 

      • Destationing of the fetal head 

    • However, these classical signs are actually not necessarily reliable and not always present! 

    • The most reliable presenting clinical symptom is actually fetal distress 

      • One study of 99 patients with uterine rupture showed: 

        • Only 13 patients reported pain and 11 had vaginal bleeding 

        • However, bradycardia or signs of fetal distress (decelerations) were present in the majority.

    • Ultrasound examination 

      • Not necessarily reliable and if you are truly suspicious of uterine rupture, this should prompt immediate delivery 

  • Why do we need to diagnose uterine rupture promptly? 

    • Maternal complications

      • Maternal circulatory system delivers 500 cc of blood to the uterus every minute 

      • Uterine rupture increases the risk of hemorrhage, with studies showing that about 50% of cases result in EBL of 2000cc or greater 

      • This can lead to need for blood transfusion, and in more dire circumstances, hysterectomy  

    • Fetal complications 

      • Depends on how quickly the neonate is delivered after recognition of uterine rupture 

      • One study showed a neonatal mortality rate of 2.6%, and increases to 6% if uterine rupture occurs outside of the hospital

        • Older literature report rates as high as 13%  

      • Many neonates will require resuscitation and admission to the NICU 

Management

  • The best form of management is prevention or setting expectations - ie. counseling 

    • All patients who desires a trial of labor after cesarean section should be counseled about the risks and benefits of TOLAC 

    • Patients should deliver at a location where labor and delivery staff, anesthesia staff, and neonatal staff are available 24 hours in order to facilitate prompt delivery if needed. 

    • Patients who are at high risk of uterine rupture (ie. classical cesarean, T-incision, prior uterine rupture, >2 cesarean sections, history of prior fundal surgery) should be counseled against TOLAC 

    • We did a whole episode on TOLAC counseling back in 2019, so check it out here: https://creogsovercoffee.com/notes/2019/9/22/trial-of-labor

      • Note that the VBAC calculator we included in those notes is outdated! 

    • There is a new VBAC calculator available that does not include race as a predictor: https://mfmunetwork.bsc.gwu.edu/web/mfmunetwork/vaginal-birth-after-cesarean-calculator

  • What if it happens? The answer is prompt delivery via cesarean delivery 

    • Urgent delivery - as quickly as possible, but within 30 minutes generally 

    • Patient can be under general anesthesia or if they already have working regional anesthesia, this can also be used 

    • Cesarean delivery should be performed, and if there is a uterine rupture, the neonate can often be delivered via the area of rupture without creating a new hysterotomy 

      • However, if there is just a uterine window, a hysterotomy may be needed 

    • Once the neonate is delivered, pediatrics should be there immediately to facilitate resuscitation 

    • If uterine rupture is confirmed, a full exam of the uterus should be done to assess for other injury 

      • Ie. bladder injury, broad ligament hematoma 

    • If possible, the area of rupture should be repaired 

    • However, if it is not possible to repair the rupture due to significant damage, patient is not stable, or significant hemorrhage, then the next step should be hysterectomy 

  • Follow-up 

    • Debriefing - this should occur with the team who was present for uterine rupture 

    • But also, should discuss with your patient when they are at a place when they can discuss what happened 

    • Counsel patient that if they desire future pregnancy, TOLAC should not be attempted due to increased risk of repeat rupture 

Espresso: Sign Out

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Read on with ACOG Committee Opinion: Sign Out

Sign Out: A Critical Moment

  • Sign out or hand off – transferring of patient knowledge and plan between two physicians or care teams. 

  • Patient care transitions represent a potential challenge to all of us:

    • Communication is challenging - different styles and preferences

    • External dynamics (interruptions, emergencies, home-life demands)

    • Internal dynamics (power differential, hierarchy, fatigue)

    • Interpersonal characteristics (defensiveness, minimizing, conflict-averse or conflict-prone)

  • Communication errors are frequently identified as pain points or root causes of safety events.

  • Three primary focuses to improve sign out:

    • Setting the stage

    • Being a good (and thorough) “giver” of sign out.

    • Being a good (and vigilant) “receiver” of sign out.

Setting The Stage for Effective Handoff

  • Preparation

    • The “giver” of signout should organize and update information to be prepared for handoff.

      • Updating any signout template or process used at your institution.

      • Reviewing daily updates to ensure most salient points are reviewed during verbal discussion.

      • Identify any tasks or specific guidance for the receiving team to complete.

        • Consider organizing sign out order by acuity/urgency or timely completion of these tasks.

  • Physical Environment

    • The environment should be set appropriately. Ideal physical environments are:

      • Quiet, and ideally away from distractions; i.e., a quiet conference room vs at nursing station.

      • Areas where patient confidentiality is preserved.

      • “Warm hand off” in a patient room as appropriate for particularly significant cases. 

      • Paper forms for hand-off should be legible and organized.

        • Fortunately many EMRs are incorporating sign-out templates, but don’t be afraid to ask your institution to modify things if needed to apply to your environment.

    • Sufficient time should be set aside to protect effective handoff.

      • Consider assigning someone specifically to address acute patient concerns during sign out - this keeps a significant amount of the team intact to focus on information exchange. 

      • This requires redundancy in those who are aware of patients on the service - sign out is a team responsibility, not an individual one!

  • Communication Environment

    • Use of medical terminology

      • Try to stick to understood medical language: i.e., “Category II for repetitive variable decelerations” instead of “this baby’s been a little naughty.” 

        • Standardized terminology allows for conveyance of the appropriate message and plan of care; colloquialisms may leave significant room for error due to being inexact.

      • Also consider language importance with respect to professional communication - attention to terms that may be culturally or personally insensitive, or the use of judgment statements rather than objective facts.

  • Culture and Hierarchy

    • Many times in OB/GYN residency, sign out is predicated on a structural hierarchy. 

      • Certainly, all patients should have a primary individual or team responsible for them, but a back-up system should be in place in case the primary contact is unavailable.

    • These hierarchies may lead to communication challenges in patient care:

      • I.e.,A student, first year resident, or RN should all be as comfortable to communicate in sign out as the senior resident or attending regarding a concern. 

        • Senior residents and attendings should role model effective communication and elicit team member concerns.

        • Senior residents sign out should strive to serve as a role model for junior team members to demonstrate communication style, active listening, and prioritization.

      • At the same time, sign out should be recognized as a patient safety event and treated the same:

        • Unique learning points for safety may be raised

        • However, sign-out is not a time to do an in-depth review on basic topics - lengthy interruptions should be avoided.

Sign Out Time: The Verbal Discussion

  • “Giver” of signout should ideally follow a standardized presentation strategy for each patient.

    • Common frameworks:

      • IPASS - Illness severity, Patient summary, Action list, Situational awareness, Synthesis by receiver.

      • SBAR - Situation, Background, Assessment, Recommendation

        • Use of a structure for sign out has been shown in some studies to reduce preventable adverse event rates by as much as 30%.

    • Verbal hand-off should focus on the most important items, and ensure your communication is structured to make those points stick for the receiver.

      • Even in optimal conditions, studies have shown that in those not using structured communication strategies, the receiver fails to identify the main concern 60% of the time! 

      • You as a giver of hand-off should prioritize issues to help the receiver, who is new to the patient - don’t make them prioritize and learn the patient simultaneously!

        • Critical to relay tasks to be done, and anticipatory guidance for events that may occur:

          • I.e., “The tracing was previously category II for some variable decelerations. If it occurs again, I would recommend an IUPC and amnioinfusion.” or 

          • “She is known to have CHF and received 2L IVF intraoperatively. If she is short of breath, she should be evaluated for pulmonary edema and if suspected, start with 60mg IV lasix per cardiology.” 

    • Giver should likewise use strategies to check receiver understanding, like read-back and interactive questioning. More on those momentarily!

  • “Receiver” of sign out has an equally important role in comprehending sign out and actively listening:

    • Read-back communication allows the sender to check that information is received by a recipient. It is rarely employed in hand-offs, but it is one of the most effective strategies to effective communication.

      • I.e., last example – “Got it. She’s at high risk for pulmonary edema. If I suspect it, I will give 60mg IV lasix.” 

    • Active listening should also be employed - that’s more than just head-nodding or uh-huh-ing!

      • Take notes

      • Ask questions

      • Clarify the plan when needed

    • If for a patient you do not hear any “critical events” or “tasks” - take that as a signal to ask!

  • Giver and receiver should both be aware that there are high risk scenarios for sign-out failure:

    • When a patient is physically moving locations

    • When a patient is clinically unstable

    • If the hand off is permanent, i.e., a service change, transfer to another facility, or a patient who is newly being admitted at sign out.

      • In these scenarios, there is evidence for higher risk of a patient safety event due to hand-off concerns.

      • Both should be acutely aware of importance of thorough sign-out in these scenarios.

Espresso: Debriefing

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What is a debrief?

  • Conversation involving frontline workers taking part in a patient’s care that occurs shortly after the event takes place.

  • Can be used for a number of purposes:

    • Knowledge or skill attainment (individual learning)

    • Describe threats to patient or worker safety, or threats to team dynamics (systems learning)

    • Provide closure for individuals involved in a clinical situation (therapeutic)

  • Debriefing is not the same as a true “root cause analysis” (RCA) but may be a first-step in performing RCA.

  • Cornerstone of clinical and simulation-based education.

When should a debrief occur?

  • Defining set triggers in which debriefs should occur has been identified as best practice to:

    • Set expectations amongst staff when they should occur, and how frequently

    • Increase frequency of debriefs

    • Promote system-wide goals

  • In OB/GYN, there’s not a standard list of what should generate a debrief; but you might imagine there’s a few major events that we commonly think of as emergencies:

    • Shoulder dystocia, or difficult extraction at cesarean

    • Significant postpartum or surgical hemorrhage events

    • Unexpected newborn complication

    • Unexpected surgical complications or unexpected intraoperative findings

    • Patient injury or serious complication, unanticipated ICU admission, or death

      • Many of these events may be defined locally; and if you don’t have a list defined at your institution, it is worth asking about it and starting one!

      • In general, it is good practice to also have a “staff member request” as a trigger for considering a debriefing to empower any person on the team to review events that may be unusual or uncomfortable.

  • Best practice has identified that the “hot debrief” (i.e., shortly after the event) is helpful to staff immediately involved and provides opportunity to get a very clear clinical picture.

    • “Cold debrief” (i.e., one done much later) will allow for more data to be collected, but worsens recall of participants and also removes some of the other advantages that a hot debrief may enable - i.e., finding time for staff to attend, identifying learning points immediately after event, etc.

    • A cold debrief can certainly be performed later on - in some institutions, this is performed through the “M&M” process with which all residents are likely familiar!

How should a “hot debrief” be done?

  • Three general stages of debriefing:

    • Preparation

    • Delivery

    • Post-Debrief

  • Preparation

    • If a debrief is requested/triggered, all staff should be invited.

    • A time and location should be identified, ideally soon after the event occurred.

    • A facilitator should be named, and a second person can serve as a scribe for documentation (more on that later)

      • Ideally, the facilitator should be a designated person who was not the team leader or heavily involved in the events. 

        • At UW L&D, this is often our charge nurse or another senior nurse who serves to facilitate.

        • This helps to eliminate any issues of hierarchy/power and encourages all voices to speak up.

    • Any other concerns to allow for optimal debrief should be addressed - short time period for cross-coverage by other personnel, for instance. 

  • Delivery

    • Facilitator should set expectations at the start:

      • Aim for brevity of debrief (5-10 minutes ideal)

      • Establish psychological safety - not to blame or punish, but to review and characterize event.

      • Invite the team leader to provide a summary of the case.

        • The facilitator should encourage the team leader to provide an objective case overview at this point - the focus should be on the “actions” that occurred. 

        • Provide reassurance that the next step of the debrief will be to focus on reflection and judgements.

      • After the event summary, the Facilitator should then start conversation according to a specific structure to review the event:

        • Many possible structures, but broadly fall into:

          • Review things that went well.

          • Review opportunities to improve.

          • Identify points for action and “take home” learning points.

        • Your institution likely has a “debrief form” that helps to guide these conversations. However, some of the more significant ones described include:

          • TALK - Target, Analysis, Learning Points, Key Actions

          • INFO - Immediate, not For personal assessment, Fast facilitated feedback, Opportunity to ask questions

          • STOP5 - Summarize, Things that went well, Opportunities to improve, Points to action, Responsibilities

          • Seven Step After Action Review - US Army tool which has been adapted to QI.

          • And many more exist!

  • Post-Debrief

    • Facilitator and scribe can review that action points are recorded.

      • If appropriate, can assign action items to specific individuals for follow up.

    • Documentation should be completed at this time.

      • Again, debrief forms are often present in hospitals for these purposes as part of QI review. Sometimes this may be incorporated into your patient safety reporting system.

    • Medico-legally, debrief processes and forms are most frequently considered protected information through quality and safety structures. 

      • Your legal department can help ensure all pieces are structured to meet this standard.

Additional Info: 

AHRQ https://psnet.ahrq.gov/primer/debriefing-clinical-learning 

Contemporary OB/GYN: https://www.contemporaryobgyn.net/view/debriefing-after-adverse-outcomes-opportunity-improve-quality-and-patient-safety