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Effective Health Care Program

Mental Health Treatments in Pregnancy

Key Questions Draft

Open for comment through Jul 30, 2018

Draft Key Questions (KQs)

Question 1: Among reproductive age women with any mental health disorder, what are the harms associated with pharmacologic interventions for a mental health disorder during preconception, pregnancy and postpartum?

Question 2: Among reproductive aged women with any mental health disorder, what are the comparative harms of pharmacologic interventions for a mental health disorder during preconception, pregnancy and postpartum?

Question 3: Among pregnant or breastfeeding women, what is the effectiveness of pharmacologic interventions on maternal outcomes

  1. Among those with anxiety?
  2. Among those with depression?
  3. Among those with bipolar disorder?
  4. Among those with substance use disorder?

Question 4: Among pregnant, or breastfeeding women, what is the comparative effectiveness of different pharmacologic interventions on maternal outcomes

  1. Among those with anxiety?
  2. Among those with depression?
  3. Among those with bipolar disorder?
  4. Among those with substance use disorder?

Contextual Questions

Within a given disorder, what are the harms of NOT treating, of stopping a treatment, or of switching medications?

Draft Analytic Framework

Figure 1. Draft analytic framework for Mental Health Treatments in Pregnancy

Figure 1: This figure depicts the key questions within the context of the PICOTS described in the previous section. In general, the figure illustrates how pharmacologic treatment may result in outcomes such as symptoms, functional capacity and quality of life and adverse events that may occur at any point after the treatment is received.

 

Background

Perinatal mental illness is a significant complication of pregnancy and the postpartum period. Common disorders include depression, anxiety, substance abuse and bipolar disorder. These disorders impair a woman's function and are associated with suboptimal development of her offspring.

The prevalence of depression is almost 20% during pregnancy and the first 3 months postpartum.1 With about 4 million births per year in the USA,2 this corresponds to about 800,000 women affected by perinatal depression each year. For anxiety, the worldwide prevalence of any clinically diagnosed anxiety disorder was 15% in pregnant women.3 According to Medicaid claims data, as of 2010, about 1.4% of pregnant women were taking an anti-psychotic (treatment for bipolar disorder) during pregnancy.4

In a 2012 national survey, 5.9% of pregnant women use illicit drugs and 8.5% drink alcohol, resulting in over 380,000 offspring exposed to illicit substances, over 550,000 exposed to alcohol. Between 2000 and 2009, the United States saw a five-fold increase in opiate use in pregnancy, coincident with the general epidemic of prescription opiate misuse.

For women who are pregnant, planning to become pregnant, post-partum or breastfeeding, decisions about treatment for mental health conditions can be challenging. Women and their treating clinicians need to consider the comparative effectiveness and potential harms of different pharmacologic treatments on the mother and fetus/infant.

Population(s)

  • KQ 1, KQ 2: Reproductive age women (15-44 years old) with any mental health disorder (new or pre-existing)
  • KQ 3, KQ 4: Women who are pregnant, postpartum, or breastfeeding, with new or pre-existing diagnosis of anxiety, depression, bipolar or substance use disorder

Interventions

  • Pharmacologic interventions for a mental health disorder including:
    • Antipsychotics (such as haloperidol, chlorpromazine, aripiprazole, quetiapine, and olanzapinem risperidone, clonidine)
    • Selective serotonin reuptake inhibitors (SSRIs) (such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)
    • Serotonin–norepinephrine reuptake inhibitors (SNRIs) (such as venlafaxine)
    • Tricyclic antidepressants (such as imipramine)
    • Mood stabilizers (such as lithium, mirtazapine)
    • Anxiolytics (such as benzodiazapines)
    • Anticonvulsants (such as valproate, lamotrigine)
    • Substance abuse disorder treatments (such as naltrexone, acamprosate)
    • Other medications for a mental health disorder

Comparators

  • KQ 1, KQ 3: Placebo or no treatment
  • KQ 2, KQ 4:
    • Include: Other pharmacologic interventions, any psychotherapy
    • Exclude: other interventions (e.g., yoga, mindfulness, self-care, CAM, brain stimulation, etc)

Outcomes

  • KQ 1, KQ 2: Harms
    • Maternal Adverse effects
      1. Infertility
      2. Miscarriage
      3. Danger to self or infant
      4. Substance use
      5. All adverse events, related to treatment or discontinuation
      6. Death
    • Fetal/Infant Adverse effects
      1. Preterm birth/low birthweight
      2. Congenital anomalies
      3. Perinatal complications (low APGAR, withdrawal, respiratory distress, NICU time)
      4. Poor Infant attachment/bonding
      5. Delayed Social, emotional and cognitive development
      6. Death
  • KQ 3, KQ 4: Effectiveness
    • Final health outcomes (Maternal Benefits)
      1. Symptoms (response/remission)
      2. Functional capacity
      3. Quality of Life
      4. Peripartum events (delivery mode, breastfeeding, weight gain)
      5. Adherence to treatment/care

Timing

  • KQ 1, KQ 2: All
  • KQ 3, KQ 4: From conception up to 1 year postpartum, or duration of breastfeeding

Setting

  • Setting: all

Definition of Terms

References

  1. O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best practice & research Clinical obstetrics & gynaecology. 2014;28(1):3-12.
  2. Statistica. Number of births in the United States from 2000 to 2016 (in millions). [web page]. 2018. Accessed April, 24, 2018.
  3. Dennis CL, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: systematic review and meta-analysis. The British journal of psychiatry : the journal of mental science. 2017;210(5):315-323.
  4. Park Y, Huybrechts KF, Cohen JM, et al. Antipsychotic Medication Use Among Publicly Insured Pregnant Women in the United States. Psychiatric services (Washington, DC). 2017;68(11):1112-1119.