External Cephalic Version (ECV)

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Background / Intro

  • Breech presentation occurs in about 3-4% of term pregnancies, with a significant number of these patients delivery ultimately by cesarean. 

  • Previously on the podcast, we covered considerations for singleton breech vaginal delivery. While that was a fun one to talk through, as we mentioned then, breech delivery is NOT the standard of care. So how do we avoid cesarean?

  • External cephalic version is the answer! Essentially, using pressure on the pregnant person’s abdomen to achieve movement of the fetus to cephalic presentation. 

  • In order to offer this service, ACOG recommends an evaluation of presentation beginning at 36’0 weeks. Check out PB 221 for more reading.

Considerations prior to ECV

  • Patients who are good candidates for ECV are:

    • At least 37’0 and EFW > 2500g. 

      • Spontaneous version after this GA is less likely.

      • Risk of reversion to breech is significantly lower after this GA or lower than this EFW.

      • If complications arise, the infant is term and can be delivered emergently with less concern regarding sequelae of prematurity. 

    • Of higher parity

      • Multiple studies have reported positive associations between multiparity and success of ECV. 

    • In transverse or oblique presentations

      • While breech is not a contraindication by any means, traveling a little less far makes it easier!

    • With less cervical dilation, and of higher station

      • Babies lower in the pelvis are tough to turn!

  • Things you might think make a difference, but actually are less important:

    • Placental location

      • Studies are mixed in this regard; some authors have found improved success with posterior placentation, while others have found no association. 

    • Amniotic fluid volume

      • This was one I always heard about in residency!

      • While it makes intrinsic sense that higher levels of fluid would lower success rates, studies have not actually demonstrated this conclusively. 

    • Maternal obesity

      • Another controversial topic where studies have been mixed in terms of predictors of success. 

    • Obesity

      • Some authors 

    • TOLAC candidates

      • The most recent interaction of the ECV bulletin addressed this question, noting there’s limited evidence for women with a preexisting uterine scar on ECV. However, in four trials, no cases of uterine rupture from ECV were reported, so it’s reasonable to offer. 

    • Ongoing labor

      • There is also limited evidence that ECV can be successful during early labor, lowering cesarean delivery rates and reducing hospital length of stay. 

Counseling for a procedure - risks and benefits

  • Benefits

    • Certainly one benefit is the option of avoiding cesarean delivery! There is a significant reduction in cesarean birth rate for women who have successful ECV in randomized studies. 

      • Interestingly, the risk is still higher for cesarean in the ECV population compared to those who present with a fetus in cephalic presentation.

    • This also comes with the benefits of greater likelihood of vaginal delivery - most notably, fewer hospital days and lower odds of endometritis and sepsis. 

    • The success rate of ECV in trials is about 60% -- so a little better than 50/50. 

  • Risks

    • Discomfort certainly is the biggest consideration -- we’re going to mash on your abdomen now! Pain medications parenterally or the use of epidurals can help reduce this element. There even is evidence that epidural anesthesia may increase success rates.

      • This should particularly be considered for women who have an unsuccessful ECV at 37 weeks, but wish to retry at 39 weeks. A placement of an epidural, followed by ECV attempt, which if unsuccessful provides anesthesia for cesarean delivery. 

    • Fetal heart rate abnormalities - fortunately, these are often transient decelerations that resolve with a pause or cessation in the procedure. 

    • Additional serious risks - placental abruption, umbilical cord prolapse, membrane rupture, stillbirth, and fetal-maternal hemorrhage have all been reported after ECV; however, all occur at rates of less than 1%. 

    • Need for emergent delivery - because of the rare risks above, women should be counseled that there is the very rare possibility of emergent delivery when ECV is attempted. ECV should only be performed in places where cesarean is readily available. 

After consenting your patient, prepare yourself for a procedure!

  • Step 1: get an NST!

    • Certainly a non-reactive or suspicious NST pre-procedure would be a reason to re-consider doing something that might cause the fetus to react poorly. 

  • Step 2: consider a cervical exam

    • If your patient has advanced cervical dilation, and you end up in the sticky situation of causing membrane rupture, it’s good to know if that 3cm cervix might drop a cord! 

    • Additionally, if you’re doing an ECV at 39+ weeks, this will let you consider what to use for induction subsequently. 

  • Step 3: ultrasound

    • Do a quick survey. Take a look at a number of things, including:

      • True presentation: frank vs complete breech, transverse, oblique. 

        • What are frank and complete breech?

          • Frank we remember this as “Frank smells his feet.” This is the “pike” presentation where the fetus is maximally extended legs and flexed at the hips.

          • Complete this is the classic cross-legged sitting position.

      • Fluid volume

      • Placental location

  • Step 4: orders!

    • Medications for ECV:

      • Pain medications -- as we mentioned above, can be considered in the form of parenteral meds or epidural anesthesia. If IV meds are given, be aware of the consequences on fetal heart rate of the med you’re giving. 

      • Tocolytics -- classically terbutaline, the B2-agonist. With relaxing the uterus, a randomized trial found that terbutaline doubled the chances of a successful ECV. 

        • There’s not much data regarding other uterine relaxants, but be aware that the beta-agonist effect of terbutaline often causes tachycardia -- so avoid in patients where that is contraindicated!

      • RhoGam -- we’re essentially inflicting trauma on the uterus. Check a type-and-screen beforehand. If delivery won’t be performed in the next 72 hours, a dose should be given.

  • Step 5: procedure time!

    • The procedure can be accomplished with one or two people.

    • Use LOTS of gel on the maternal abdomen to prevent trauma to the skin and facilitate easy ultrasound access for fetal heart rate checks. 

    • Classically, the procedure involves lifting the breech out of the pelvis with one hand, and then using pressure on the fetal head to facilitate a forward or backward roll. 

      • The procedure is successful when cephalic presentation is accomplished.

      • The procedure should be abandoned if there is prolonged bradycardia, extreme maternal discomfort, or if a few attempts have been unsuccessful. There’s no “right or wrong” number but having attempted many of these, you get a sense of whether they’ll roll or not. 

      • A great video of technique can be seen at https://www.youtube.com/watch?v=aWTmxPV15DI

    • Usually, institutions will have a monitoring protocol post-ECV attempt -- ACOG recommends at least 30 minutes of continuous monitoring, regardless of success.

Espresso: Shoulder Dystocia

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What is shoulder dystocia?

  • After the delivery of the fetal head, the fetal anterior shoulder gets caught on the maternal pubic symphysis.

  • Less common: posterior shoulder is impacted by the maternal sacral promontory 

  • Reported incidence: ranges from 0.2-3% of vaginal deliveries

  • Most often recognized when after delivery of the head, there is not easy delivery of the shoulders with gentle traction on the head. Can often see a “turtle” sign, when there is retraction of the fetal head from the maternal perineum 

  • Risk factors 

    • Fetal macrosomia - and anything else that can cause it

      • Think maternal diabetes - Type I, Type II, or GDM, especially if poorly controlled 

    • History of shoulder dystocia (recurrence rate is 10%) 

    • Unfortunately, nothing has been reliably found to predict shoulder dystocia, including history, presence of diabetes, or even EFW or abdominal circumference to BPD ratio 

Why do we care about shoulder dystocia? 

  • Risks to mom

    • Increased risk of postpartum hemorrhage (11%) 

    • Increased risk of 4th degree laceration (3.8%) 

    • Also performance of certain “heroic measures,” ie. Zavanelli and symphysiotomy (ouch) have significant risk for mom (ureteral injury, uterine rupture, cervical laceration, bladder injury)  

      • Thankfully they are rare !

      • I have never seen it in real life, but there is an … interesting episode with eclampsia, forceps, and shoulder dystocia all in one with Zavanelli’s maneuver on an episode of ER (Love’s Labor Lost, Season 1 Episode 19) from 1995.

  • Risks to baby 

    • Most shoulder dystocias resolve without injury to the baby, but there is a higher overall neonatal injury rate, about 5.2% from a recent multicenter study in 2018 

    • Increased risk of brachial plexus injury from hyperextension of neck one way or the other → Erb palsy, Klumpke palsy 

    • Increased risk of clavicular or humeral fracture 

    • More rare is hypoxic-ischemic encephalopathy (HIE) 

    • Interestingly, the length of shoulder dystocia itself is not an accurate predictor of neonatal asphyxia or death 

How do we manage shoulder dystocia? 

  • Prevention of shoulder dystocia 

    • Again, we cannot accurately predict shoulder dystocia, so unfortunately… it’s not easy to figure out what to do to prevent.

    • There have not been big trials looking at this time, but according to some studies looking at the cost analysis, there is some suggestion that offering primary cesarean for fetuses >5000g in non-diabetic mothers and >4500g in diabetic mothers may be “worth it.”

    • Similarly, you can consider for patients with history of shoulder dystocia where recurrence risk is ~10%.

    • What about induction of labor? 

      • Basically, there have been a lot of studies, but currently, evidence is unclear if there is benefit for earlier induction of labor vs. expectant management alone for shoulder dystocia prevention.

Maneuvers for shoulder dystocia/how to manage a shoulder dystocia

  • Every hospital is going to be different, but this is how we were trained!

    1. Recognize a shoulder: turtling, shoulder not delivery easily despite gentle downward traction on the head 

    2. Communication: let the room know that there is a shoulder dystocia, ie. “We have a shoulder dystocia” - usually this will kick off a series of events 

      • The nurse may call for help, at our current hospital, there is an “emergency lever” that is pulled and help will come  

      • Talk to mom and ask her to stop pushing: “Ms. X, baby’s shoulder is stuck behind the pubic bone. I’m going to ask you to stop pushing while we help baby get out.”   

      • Once you call a shoulder dystocia, usually institutional implementation of someone to be recorder - call time, document maneuvers tried 

    3. Positioning: have nursing/other providers move mom down on the bed so that the perineum is right at the edge of the bed. Then place mom in McRobert’s maneuver, where the hips are flexed back, opening the pelvis.

    4. Maneuvers: there are no randomized controlled trials for what is better, but there are some logical steps to take that are easy to employ (McRobert’s, suprapubic pressure, and posterior arm will relieve 95% of shoulder dystocias in 4 minutes or less) 

      • Suprapubic pressure: another provider places pressure suprapubically to push the impacted shoulder under the pubic symphysis. This needs to be done in the correct direction. Often, we take a moment to figure out which shoulder is impacted and which direction it should go. Then direct the other provider by indicated with your hand or finger (“I want suprapubic pressure in this direction”) instead of verbally, because that can get confusing (ie. which right?) 

      • Posterior arm: some recent studies have shown that delivery of the posterior shoulder leads to a high success rate. This involves placing a hand into the vagina, finding the posterior arm and delivering it first. Sometimes, this may be more difficult, as it involves identifying the arm and hand, flexing it at the elbow, and gently pulling the arm around the head. If there is little room, may also require an episiotomy. 

        • Posterior shoulder sling - thread a catheter under the posterior armpit and deliver posterior shoulder this way 

      • Rubin and Woodscrew Maneuvers: Rubin’s involves placing a hand into the vagina and rotating the posterior shoulder anterior toward the fetal head. Woodscrew involves placing the hand on the anterior surface of the posterior fetal clavicle to turn the posterior shoulder until the anterior shoulder emerges.

      • Gaskin Maneuver: have the woman get on all fours and place pressure on the posterior pressure downward or upward traction on anterior shoulder.

***If these don’t work, try again. A study of 231 cases showed no association between maneuvers and neonatal injury. Try what works !

More aggressive maneuvers

  • Zavanelli’s - when everything else has been tried, if the only other option is abdominal rescue for catastrophic cases, place pressure on the head to go back up through the vaginal canal for cesarean delivery 

  • Symphysiotomy - cutting the symphysis. Not really a modern option in the era of readily available cesarean delivery, but has been performed in lower resourced settings.

  • Breaking fetal clavicle - may decrease AP diameter, but may be difficult to perform. Always break in a manner that is away from the fetal chest (ie. pull clavicle away from body) to avoid damaging underlying structures.

Simulation is key to success in managing shoulder dystocia as a team! - if you don’t have this already, please ask about SIMing a shoulder dystocia at your institution.

  • Not only to make providers more comfortable, but studies have also shown that team training protocols and sim have been associated with reduction in transient brachial plexus injury.

  • Increased evidence-based management of shoulder dystocia.



The Standardized Cesarean Section

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Back in June 2019, we did an episode on The Evidence-Based Cesarean Section. Back then, we talked a bit about incision types, infection practices, and some in surgical technique. In the November 2020 Green Journal, two of our podcast guests - Dr. Josh Dalhke and Dr. Jeff Sperling, in addition to their coauthors - make the case for standardizing cesarean delivery technique.

The text is definitely worth a read, as it’s a succinct review of the most current literature. Some of the practices you may employ already; others you may be surprised by! We talk a bit more with these two authors about the recommendations, what was most surprising, and what things are to come.

This checklist comes from the article, and is definitely worth discussing at your institutions. We’ll let the podcast speak for itself otherwise.

Dahlke et. al, O&G, Nov. 2020 — hyperlink above

Stillbirth

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Stillbirth is defined as fetal loss at 20 weeks’ gestation OR, if gestational age is unknown, then loss of a 350-gram fetus (which is the 50%tile weight at 20 weeks). Of note, this definition varies internationally. Stillbirth is synonymous with intrauterine fetal demise; some parent groups prefer the term stillbirth and recent research has started using this term instead. Its incidence is 1 in 160 deliveries in the United States, amounting to ~23,600 stillbirths reported annually in this country. 

Potential causes of stillbirth:

  • Placental abruption: identified as the cause of stillbirth in 5-10% of cases 

  • Genetic abnormalities: an abnormal karyotype can be found in ~6-13% of stillbirths

  • Infection: associated in 10-20% of stillbirths 

  • Umbilical cord events: account for ~10% of stillbirths 

The Stillbirth Collaborative Research Network published a study that evaluated 512 stillbirths and identified a probable cause in almost 61% of cases. A possible/probable cause was identified in 76.2% of cases. They discovered that the placental pathology had the highest diagnostic yield (aiding in almost 65% of the cases) followed by fetal autopsy (in 42% of the cases).

How to workup a cause of stillbirth:

Maternal Workup:

    • Medical history: diabetes, cHTN; autoimmune disease; thrombophilias, VTE; epilepsy

    • Exposure history: medications; infections; tobacco, alcohol or drugs

    • Obstetric history: recurrent pregnancy loss (RPL); fetal growth restriction

    • Family History:

      • Three-generation pedigree including stillborn infants and RPL

      • Liveborn infants w/ developmental delays or structural anomalies

      • Arrhythmias and sudden death (SIDS) 

Maternal laboratory evaluation:

  • Syphilis testing

  • KB testing once diagnosis is made – and ideally before delivery because KB testing can be falsely elevated after delivery

  • Antiphospholipid antibody syndrome: One of the clinical criteria for diagnosis of APS is stillbirth: “One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetal morphology documented by ultrasound or by direct examination of the fetus.”

  •  Routine testing of inherited thrombophilias has NOT been shown to be helpful. 

    • Other testing that is not helpful includes a full infectious serology panel 

  • HbA1c should be obtained for patients with diabetes or suspected diagnosis of thereof.  

Grief and Bereavement: 

  • Patient support is two part: emotional support and clear communication of test results 

  • Important to recognize their parenthood and acknowledge their grief, offer referrals to bereavement counselors and peer support groups, and communicate results of the workup in a timely manner. 

  • A provider may feel at loss of words when approaching grief-stricken parents for consent on autopsy and further workup. At times, providers may not feel as though they’ve developed a strong enough rapport with the parent group so may not offer an autopsy to parents due to the concern that it may upset parents further. However, it is important to consider that the evaluation may provide answers and closure for these parents.

    • In fact, a study done by Rankin et al. estimated that parents who did not consent to a postmortem examination were approximately twice as likely to regret their decision compared tho those who chose to have this investigation performed. 

Autopsy:

There are two types of autopsies: a partial and a complete autopsy.

A partial autopsy involves gross inspection of the fetus and placenta, ideally by a trained perinatal pathologist, and imaging studies. Approximately 20% of stillborn fetuses have dysmorphic features or skeletal abnormalities; of these, about 36% will have chromosomal abnormalities (Monosomy X, Trisomies).

Gross inspection would include measuring the weight of the fetus and the placenta, the head circumference and the length of the fetus, as well as obtaining frontal and profile photographs of the whole body, face, extremities, palms and any abnormalities.  

Gross and microscopic evaluation of the placenta, as well as umbilical cord and membranes by a trained pathologist is the single most useful aspect of the stillbirth evaluation. Here the pathologist can evaluate for abruption, umbilical cord thrombosis, velamentous cord insertion, vasa previa, infection, and anemia  

Cytogenetics Evaluation:

  • Usually done with karyotyping or microarray. Although new research studies are underway to evaluate if whole genome sequencing may yield better diagnostic utility, it is not currently part of the standard genetics workup in stillbirth evaluations. 

  • The cytogenetic specimens are obtained with sterile techniques and instruments. Acceptable cytogenetics specimens include (place these specimens in a sterile tissue culture medium of lactated ringers solution and keep at room temperature. Do not place in formalin!):

    • Amniotic fluid obtained by amniocentesis at time of prenatal diagnosis. GOLD STANDARD

    • Internal fetal tissue specimen, such as costochondral junction or patella; skin is not recommended 

    • Placental block (1x1cm) taken from below the cord insertion site below the unfixed placenta

    • Umbilical cord segment (1.5cm) 

  • Techniques for cytogenetics evaluation include karyotyping which is fast and relatively inexpensive but can underestimate the contribution of genetic abnormalities because in up to 50% of karyotype attempts, cell culture is unsuccessful.

  • Chromosomal microarray can detect smaller deletions and duplications as well as aneuploidy. Compared to karyotype analysis, microarray analysis increases the diagnosis of a genetic cause to almost 42%. 

  • Recently, there is new evidence to suggest that whole exome sequencing may further increase diagnostic yield in the evaluation of stillbirth.

In Future Pregnancies:

  • Offer aneuploidy screening, sonographic screening for fetal growth restriction after 28 weeks and antenatal fetal surveillance as detailed below.

  • Antenatal fetal surveillance:

    • For patients with a previous stillbirth at or after 32’0 weeks, once or twice weekly antenatal surveillance is recommended at 32’0 weeks or starting at 1—2 weeks before the gestational age of the prior stillbirth

    • For prior stillbirths that occurred earlier than 32 weeks gestation, individualized timing of antenatal surveillance should be considered. 

      • Of note, antenatal fetal surveillance could lead to iatrogenic preterm deliveries based on false-positive test results. One study estimated a 1.5% rate of iatrogenic prematurity for interventions based on false-positive results, so this must be weighed in when deciding on type/frequency of surveillance. 

  • Delivery: planned delivery at 39 0/7 weeks of gestation or as dictated by other maternal or fetal comorbid conditions. 

COVID-19 Updates for Pregnancy

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Since our update in March, we now have much more data – so much in fact that it may be really hard for everyone to synthesize it all. Our hope is to help a little with the synthesis and present the information out there in a digestible way – obviously we won’t be totally comprehensive, but we’ll do our best!

Pregnancy and COVID-19 Risk

The CDC released a new morbidity and mortality weekly report (MMWR) in November 2020:

  • Looked at data from 1/22-10/3/2020 with delay for data updates up to 10/28/2020 in both pregnant and nonpregnant symptomatic women between the ages of 15-44 (reproductive age).

    • 409,462 symptomatic women 

    • 23,434 (5.76%) symptomatic pregnant women 

  • Suggestion: pregnant women are MORE likely to have severe COVID-19 associated illness. After adjusting for age, race, other med conditions, pregnancy women were: 

    • More likely to be admitted to the ICU (10.5 vs 3.9/1000 cases, ARR 3.0) 

    • More likely to receive ventilation (2.9 vs 1.1/1000, ARR 2.9) 

    • Receive ECMO (0.7 vs 0.3/1000, ARR 2.4) 

    • And die… (1.5 vs 1.2/1000, ARR 1.7) 

  • Some other interesting findings: 

    • Older pregnant women were more likely to have ICU admission/severe disease, comparing women 35-44 with women 15-24 (19.4 vs 7.6/1000 cases) 

    • Black women had higher risk of death (made up of 14.1% of all women involved, but represented 36.6% of deaths overall, including 26.5% of pregnancy deaths) 

    • Increased risk of ICU admission for Asian women (ARR 6.6) and native Hawaiian/Pacific Island women (ARR 3.7) 

    • In pregnant Hispanic women, pregnancy was associated with 2.4x risk of death 

  •     Some limitations: 

    • COVID-19 cases rely on voluntary report by health care providers and public health officials/agencies 

    • Reporting bias – we might report more if there is more severe disease (less likely to report asymptomatic or mild disease) 

    • Severe outcomes might require more time to ascertain (why they had time lag of 10/28 when looking at cases reported through 10/3/2020).

Smaller studies have been performed to assess other pregnancy outcomes. Studies may be too small to be powered for these differences, but are still being actively studied:

  • Preterm labor/stillbirth 

    • Overall during the pandemic:

      • Danish report showed decreased preterm birth rates overall;

      • Another UK study showed increased rates of both;,

      • JAMA Dec 7, 2020 in Philadelphia did not show increased rate during the pandemic. But conflictingly, a study in the same city in October showed that there was a decreased PTB rate at one hospital 

      • Could hypothesize these varying outcomes may be due to different time periods, different lock-down methods, etc. 

  • PEC/cesarean deliveries/PTB in people with COVID 

    • One study from Texas looked at 3374 women who were tested for COVID, of whom 252 were positive.

    • In positive women, there was no difference in composite outcome of PEC w/ SF, cesarean delivery, or PTB.

  • Looking at PTB from the Birth and Neonatal Outcome MMRC from CDC: there was a preterm birth rate of 12.9% in women with COVID-19 infection, which was higher than general population in 2019 (10.2%), so maybe there is an increased risk for preterm delivery.

Birth and Neonatal Outcomes after COVID-19 

There has been concern about perinatal infection in women who are COVID-19 positive and laboring. Fortunately we’ve got some reassuring data on this front from the CDC:

  • 5252 women with lab-confirmed COVID-19’s babies  610 (21.3%) of infants had reported COVID results

    • Perinatal infection – uncommon (16, 2.6%) and occurred primarily among infants whose mother had COVID ID’ed within 1 week of delivery.

    • 8 of the infants were born preterm (26-35 weeks) and admitted to NICU 

    • 8 term infants who were positive, one was admitted to NICU for fever and O2, the others were not admitted, and one did not have info.

COVID-19 Vaccination in Pregnant and Breastfeeding People  

When we recorded the episode, we spoke primarily about the Pfizer vaccine. This information should apply in broad strokes the the Moderna vaccine as well, now that it has received approval as the 2nd mRNA vaccine.

  • mRNA vaccine – What is it, how does it work? 

    • mRNA: messenger RNA. It is single-stranded RNA molecule that is complementary to one of the DNA strands of a gene. Reaching back to med school: mRNA leaves the cell nucleus and moves to the cytoplasm where they code for different protein synthesis. Ribosome will move along the mRNA, read the base sequence, and use the genetic code to translate three-base triplet (codon) into its corresponding amino acid 

    • tRNA: which is attached to an amino acid, will match with mRNA to generate a sequence of amino acids to make up a protein 

  • The COVID-19 mRNA vaccine gives instructions to our cells to create a “spike protein,” which is a harmless piece of protein that is found on the surface of the virus that causes COVID-19 

  • Once the mRNA is used, the cell gets rid of the material… so you can’t get infected with COVID-19. It also doesn’t get encoded into our DNA!

    • Once your cell makes the protein, it presents it on the surface of the cell. The immune system will recognize that this protein doesn’t belong there and begin to build up an immune response and make antibodies, kind of like what would happen in the natural infection against COVID-19. 

    • At the end of the process, your immune system will recognize these surface proteins from COVID-19 and have the ability to fight them off, so if you come into contact with COVID-19, your immune system will be ready 

  • How was it developed so fast? 

    • Most of the time, vaccine trials take a long time because there are hang-ups in things that have nothing to do with science: funding, IRBs approval, etc.

    • But because this was coronavirus, there was a lot of funding and momentum from Operation Warp Speed.

    • Pfizer received $1.95 billion in July for production of 100 million doses of vaccine, and Congress directed almost $10 billion to the overall effort of vaccine development/distribution. Most of the time, vaccine research does not get this much money all at once! 

  • Is it safe?

    • For the Pfizer vaccine, the Phase 3 clinical trial began on July 27 and enrolled 43,661 participants, and 41,135 received a second dose

    • The trial concluded 11/13/2020, so there is at least 3.5 months’ worth of data. We don’t really expect long term outcomes to be different… since mRNA gets destroyed by the body so quickly.

    • Findings: 

      • Looking at 28 days after first dose of vaccine (remember, we need time for the vaccine to work), there were 170 confirmed cases of COVID-19: 162 in the placebo group vs. 8 in the vaccine group.

      • Efficacy was consistent across age, gender, race, and ethnicity demographics.

      • Efficacy was 95% overall, and 94% in adults >65 years of age.

      • Safety in general: well tolerated across all populations, no serious safety concerns observed. The only Grade 3 adverse event >2% in frequency was fatigue (3.8%) and headache (2.0%). Older adults tended to report fewer and milder solicited adverse effects following vaccination 

    •  What about reports of the 6 people that died in the Pfizer Phase III trial? 

      • 6 people did die in the trial. 4 were in the placebo arm, and 2 were in the actual vaccine arm.

        • Of the two that died: 1 was reported to have serious adverse event related to arteriosclerosis and died 3 days after dose 1; the other had a cardiac arrest 60 days after dose 2 and died 3 days later. Both were > 55 years of age. 

        • Of the 4 that died in placebo arm: 1 died 8 days after dose 1 with unknown event, one died of hemorrhagic stroke 15 days after dose 2, one died 34 days after dose 2 (unknown event), one died of MI 16 days after dose 1. 

    • Other serious adverse events 

      • The non-fatal SAE was 0.6% in the vaccine group and 0.% in the placebo group 

      • Vaccine group had higher rates of appendicitis (0.04%), acute MI (0.02%), and CVA (0.02%)

      • Placebo arm had higher rates of pneumonia (0.03%), afib (0.02%), and syncope (0.02%) 

    • Editorializing here: but the overall small numbers, the variety of things that occurred, and the lack of biologic plausibility in these SAEs suggest these likely happened by chance.

  • Should pregnant and breastfeeding people get vaccinated? 

    • Unfortunately, pregnant and breastfeeding people were excluded from the study 

    • Currently, the FDA has not excluded pregnant and breastfeeding people from getting the vaccine 

    • SMFM is in agreement – recommend that pregnant and lactating people have access to the vaccine 

    • Can engage in discussion about potential benefits and unknown risks with their providers