Inflammatory Bowel Disease (IBD)

We’re joined back today by Dr. David Abel, an assistant professor in OB/GYN at Oregon Health and Sciences University. Newly joining us today is Dr. Rachel Madding, who is a PGY-2 at OHSU. Together they share with us some pearls about IBD and IBD in pregnancy, specifically!

Overview of IBD 

• Comprised of two major disorders:

  • Ulcerative Colitis (UC)

    • Affects the colon and is characterized by inflammation of the mucosal layer.

    • Key defining symptom is bloody diarrhea.

    • UC can also be associated with systemic findings including uveitis, scleritis, erythema nodosum, pyoderma gangrenosum, arthritis, lung disease, and venous thromboembolic disease.

    • Notable for rectal involvement, with a continuous pattern of inflammation.

  • Crohn’s disease.

    • Can involve any component of the gastrointestinal tract from the oral cavity to the anus.

    • Characterized by transmural inflammation often with skip lesions.

    • It may also include perianal and rectal involvement about 50% of the time. 

    • Symptoms of Crohn’s are highly vari­able and include fatigue, diarrhea, abdominal pain, weight loss, rectal bleeding, fistula, perianal abscess formation and aphthous ulcers.

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Epidemiology of IBD

• Approximately 1.6 million Americans have IBD.

  • About 70,000 new cases diagnosed in the US each year.

  • More than 50% of those with IBD are women and will carry the diagnosis during their reproductive years.

    • For every 100,000 deliveries, approximately 130 will be complicated by IBD.

    • Crohn’s disease in particularly seems to carry a slight female preponderance.

IBD and Pregnancy-Specific Risks

• Patients with IBD appear to be at increased risk of preterm delivery, low birth weight, and cesarean delivery.

  • Active disease, particularly at the time of conception, seems to increase the risk of adverse outcomes.

• Preterm delivery is the most consistent adverse outcome associated with IBD disease activity in pregnancy.

  • A meta-analysis of over 3900 pregnant women with IBD showed an increased rate of preterm delivery and low birth weight by approximately 2-fold, regardless of disease activity as com­pared with patients without IBD.

  • Large population-based studies have also shown that patients with IBD have a 1.5- to twofold increase in the rate of cesarean delivery.

    • The etiology of the association of IBD with adverse pregnancy outcomes remains unclear.

    • One theory is that IBD represents a generalized inflammatory state.

• With regards to other adverse perinatal outcomes, the data is conflicting.

  • Possible increased risks of spontaneous abortion, preeclampsia, eclampsia, placental abruption, fetal distress, placenta previa, and premature rupture of membranes.

• VTE Risk

  • Increased risk of venous thromboembolism in patients with IBD

  • The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy recommends consideration of prophylactic anticoagulation when a pregnant patient with IBD is hospitalized for an IBD flare, or after undergoing a cesarean section. 

    • The American College of Chest Physicians does not consider IBD specifically as a venous thromboembolism risk factor, however it does recommend post-cesarean prophylactic anticoagulation for those with one major or at least two minor risk factors for VTE.

Pregnancy’s Impact on IBD

• Risk of having a flare during pregnancy in patients with quiescent disease is similar to the nonpregnant patient.

  • For those who conceive when their disease is quiescent, disease tends to remain in remission throughout the pregnancy and postpartum.

  • Among patients with Crohn’s disease who conceive while their disease is active, the disease goes into remission in one-third, remains stably active in one-third, and worsens in one-third.

  • Patients with UC in pregnancy often have more active disease compared with Crohn’s.

• Medication Use:

  • Greatest risk to their pregnancy is active disease at the time of conception, so discontinuing their medication during this time can have adverse effects.

  • Most medications are not associated with congenital anomalies and adverse perinatal outcomes.

  • There are several classes of medications including corticosteroids, which are used to treat flares mostly, aminosalicylates, antibiotics, immunomodulators and biologics.

    • Aminosalicylates i.e., sulfasalazine and mesalamine

      • Commonly used in UC to reduce intestinal inflammation.

      • Not associated with fetal risks, but may increase nausea and gastrointesti­nal reflux in pregnancy.

      • Should be given with at least 2 mg folic acid during pregnancy because of antifolate effects.

    • Antibiotics primarily used for flares and complications such as pouchitis and perianal disease.

      • Generally avoid fluoroquinolone.

    • Immunomodulators

      • Azathioprine, cyclosporine, 6-mercaptopurine can be used.

        • Data suggests a high rate of relapse when these drugs are discontinued.

      • Methotrexate and thalidomide are contraindicated

        • For those who are taking methotrexate, the recommendation is to wait 3-6 months after discontinuation before trying to conceive.

    • Biologics / anti-TNF agents

      • Increasingly used in the treatment of both IBD and autoimmune conditions

      • Infliximab, also known as remicade, adalimumab, also known as humira, and certolizumab, also known as cimzia.

      • These agents are IgG antibodies and cross the placenta

        • Exception: certolizumab, which does not cross the placenta because it lacks the necessary Fc receptor to facilitate placental transfer.

      • Safety data from prospective trials and large nationwide cohorts of women who continued taking biologics in pregnancy have not shown an increase in adverse fetal outcomes.

        • The greatest amount of safety data is for infliximab and adalimumab, which have shown no increased rates of congenital anomalies or infections among infants up to 1 year of age who were exposed to these agents in utero.

        • PIANO study (Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes): no increase in adverse events based on drug exposure during pregnancy or placental transfer of biologics.

      • Biologics may result in B cell suppression in the infant; however, this appears to subside after 4-6 months.

Mode of Delivery Considerations with IBD

• All patients have the option of having an elective primary cesarean section.

• For most patients, a vaginal delivery is encouraged as the risks of a cesarean section are greater.

  • For those with Crohn’s disease and a history of perianal disease but no current active disease, a vaginal delivery is reasonable, although some may still elect to undergo cesarean section.

    • For those with active perianal disease, a cesarean section is often performed due to concerns for complicated perianal and/or sphincter injury and healing.

  • For those with UC who have undergone an ileal pouch anal anastomosis, also referred to as an IPAA or J-pouch, a cesarean delivery is often performed due to concerns for anal sphincter injury and pouch dysfunction.

    • However, a history of an IPAA is not an absolute contraindication to a vaginal delivery.

Preconception Counseling Pearls

• Stress the importance of remaining on their medications, unless taking MTX.

• Patients need to know that if their disease is quiescent prior to pregnancy, this portends a more favorable course during pregnancy.

  • Most patients with inactive disease do well during pregnancy.

  • It is important to watch for a flare in the postpartum period.

• For patients who have active disease, ideally contraception until disease is controlled is important to reduce the risk of adverse perinatal outcomes.

• Most patients should be under the care of a gastroenterologist

  • If not, it is important to reestablish care, as a multidisciplinary approach serves to optimize outcomes.

A Critical Examination of Abortion Terminology

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

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

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

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

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

Espresso: Sign Out

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.

Advanced Maternal Age (AMA)

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Check out the new ACOG/SMFM Obstetric Care Consensus #11, Pregnancy at Age 35 Years or Older.

Why do we care about age in pregnancy? 

• Maternal age 

• CDC data (2020): continuing upward trend in the mean age of pregnant people in the US 

  • 19% of all pregnancies are currently in people 35 and older 

  • Mean age of people having their first birth in 2020 was 27.1, compared to 21.4 in 1970 

• Pregnancies in patients that are older are associated with higher risks, even if they come into the pregnancy as healthy individuals 

• Definition 

• Advanced maternal age: women who are 35 years or older at estimated date of delivery.

  • Why 35?

    • Selected based on evidence of declining fertility and concern surrounding increased risk for genetic abnormalities in babies born to those who are over the age of 35 

    • This has been a historical figure that we have used – this threshold is pretty arbitrary 

• Some risks associated with older age may not influence outcomes until even later in life (ie. 40 and older) 

  • The risk is on a continuum - there is no jump in risk just because someone hits 35 

  • More recent studies will stratify risk by age group, so for example, will divide out patients by age in 5 year increments (ie. 35-39, 40-44, etc).

Risks of AMA Status

• Pregnancy risks

• Compared to those of younger age, patients who are >35 at time of delivery are at higher risk of

• Gestational diabetes,

• Preeclampsia,

• Labor dystocia, and

• Cesarean delivery  

• Fetal/neonatal risks 

• Increased risk of preterm delivery

• Increased risk of NICU admission, low birth weight 

• These risks are on a continuum, with risks increasing progressively with advanced age, particularly in those older than 40 at the time of delivery 

• When looking at cohort studies, women 45-54 were at the highest risk of overall complications 

• Chronic medical disorders 

• More prevalent in individuals >35 years of age 

• Include things like obesity, hypertension, diabetes - studies show that pregnant people 35 or older are 2-4x more likely to have cHTN and nearly twice as likely to have T2DM as pregnant people 25-29 years old 

  • These are also risk factors for poor outcomes.

Considerations in pregnancy care for=patients older than age 35:

• Prevention of Preeclampsia 

• There is increased risk of preeclampsia in pregnancy patients older than 35 

• In one large meta-analysis, the risk of preeclampsia progressively increased with increasing age.

• However, the difference was only statistically significant in women aged 40 years and older 

• In USPSTF systematic review, there was reduction in risk of preeclampsia, preterm birth, small for gestational age, and perinatal mortality in individuals at increased risk of preeclampsia who took low-dose aspirin prophylaxis. 

• Recommendation: start low-dose aspirin (81 mg/day) ideally between 12-16 weeks of gestation, and continue daily until delivery in those at high-risk of preeclampsia 

  • Those who are 35 or older are at moderate risk of preeclampsia, so it is reasonable for those who are 35 or older with one high risk factor or at least one additional moderate risk factor to start low-dose aspirin therapy 

• Other moderate risk factors:

• Nulliparity

• Obesity (BMI >30)

• Family history of preeclampsia

• Black race (as proxy for underlying racism)

• Lower income

• Personal history factors (ie. low birth weight, previous adverse pregnancy outcome)

• IVF  

•  High risk factors 

• History of preeclampsia

• Multifetal gestation

• Chronic hypertension

• Pregestational diabetes,

• Chronic kidney disease

• Autoimmune disease

• Genetic Screening 

• Over time, there is decrease in oocyte and oocyte quality 

• Decline accelerates in 4th decade of life likely due to myriad of hormonal changes regulating the ovaries 

• Individual’s fertility will decline with increasing age 

• Frequency of aneuploidy will increase with age 

• However, not all aneuploidies or genetic abnormalities increase with age:

  • Sex chromosome trisomies and other trisomies increase with age 

  • However, sex chromosome monosomies and copy number variants seem to be independent of maternal age at pregnancy 

• Pregnant individuals should be aware of these risks and therefore, clinicians should be ready to discuss prenatal genetic testing (both screening and diagnostic) 

• There is conflicting data about increased risk of major congenital anomaly affecting the fetus in patients who are 35 years of age or older.

  • However, a detailed fetal anatomic survey should be done.

ACOG/SMFM OBSTETERIC CARE CONSENSUS #11

• Growth abnormalities 

  • Both large for gestational age and small for gestational age occurs in neonates at higher frequencies as maternal age increases.

    • Most of this data is for patients who are age 40 or above 

  • Insufficient evidence to recommend ultrasound for growth assessment in third trimester for individuals 35-39 years of age in absence of other risk factors 

  • But given the data for individuals age 40 and above, SMFM and ACOG recommend a growth ultrasound in the third trimester 

    • However, there is no data to guide timing or frequency of ultrasound assessments in individuals 40 or older 

• Prevention of stillbirth 

• We know there is increased risk of stillbirth with advancing age in pregnancy:

• In 2013, the stillbirth rate in the US was 6.0/1000 pregnancies that extended beyond 20 weeks of gestation 

  • For women 40-44: 10.1/1000 births 

  • For women >45: 13.8 /1000 births 

  • Risk of stillbirth at 37-41 weeks was 1/382 pregnancies for those 35-39, 1/267 in women 40 and older 

• However, the benefit of antenatal fetal surveillance to reduce the risk of stillbirth in this population remains unknown.

  • ACOG and SMFM have established guidance that suggests surveillance for conditions where stillbirth occurs more frequently than 0.8/1000 

  • Therefore, for those who will be 40 or older at time of delivery, antenatal surveillance is reasonable.

  • Reasonable to initiate some time between 32- 36 weeks of gestation 

  • Insufficient evidence for those 35-39 years of age

• Regarding delivery 

• Rate of stillbirth at 39 weeks in women 40 or older is nearly the same as rate of stillbirth of women aged 25-29 who are beyond 41 weeks gestation 

  • Therefore, delivery in well-dated pregnancies at 39 weeks of gestation or later for individuals 40 or older should be considered 

• Evidence for elevated stillbirth risk in individuals aged 35-39 is not sufficient to support a clear recommendation regarding timing of delivery beyond routine practice 

• Health equity 

• There is currently inequity in terms of maternal mortality and perinatal outcomes in patients who identify as non-Hispanic Black, as well as those that identify as American Indian and Alaskan Native 

• Maternal mortality 

• CDC Pregnancy Mortality Surveillance System data shows that maternal mortality trends determined a pregnancy related mortality ratio of 3.2 for non-Hispanic Black women compared to non-Hispanic White women 

• Ratio increased to 4.9 for non-Hospanic Black women between ages 35-39 

• 3.6 for women aged 40 years and older 

• Fetal outcomes 

• Preterm birth, SGA, stillbirth occur more frequently in some racial and ethnic groups that are disproportionately affected by social and structural barriers to care 

• Infant mortality rate for non-Hispanic black and American Indian/Alaska Native infants are 10.7/1000 live births and 7.9/1000 live births respectively 

• This is double the rate of non-Hispanic white infants 

• It is unclear the best strategy to overcome these inequities, but: 

• Ob/Gyns and other professionals should consider systems-based and individual strategies to reduce racial and ethnic disparities in care and outcomes 

• Systems: internal assessment of barriers and facilitators to providing equitable care, implementing unconscious bias and communication training, advocating for patient input in decision making 

Espresso: Debriefing

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