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## Complete Summary

#### GUIDELINE TITLE

Management of thyroid dysfunction during pregnancy and postpartum: an
Endocrine Society clinical practice guideline.

#### BIBLIOGRAPHIC SOURCE(S)

The Endocrine Society. Management of thyroid dysfunction during
pregnancy and postpartum: an Endocrine Society clinical practice
guideline. Chevy Chase (MD): The Endocrine Society; 2007. 79 p. \[281
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Thyroid dysfunction during pregnancy and postpartum including:

-   Hypothyroidism

-   Hyperthyroidism

-   Gestational hyperemesis and hyperthyroidism

-   Autoimmune thyroid disease

-   Thyroid nodules and cancer

-   Postpartum thyroiditis

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Treatment

#### CLINICAL SPECIALTY

Endocrinology\
Family Practice\
Obstetrics and Gynecology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To provide clinical guidelines for the management of thyroid problems
present during pregnancy and in the postpartum

#### TARGET POPULATION

Pregnant women and women who are postpartum with thyroid dysfunction

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Management/Treatment**

1.  Targeted case finding of hypothyroidism at first prenatal visit

2.  Adjustment of preconception thyroxine dose

3.  Thyroid function testing

4.  Differential diagnosis of hyperthyroidism

5.  Antithyroid drug therapy

    -   Propylthiouracil

    -   Methimazole

6.  Thyroidectomy

7.  Measurement of thyroid receptor antibodies

8.  Fetal ultrasound

9.  Umbilical blood sampling, as appropriate

10. Assessment of newborns for thyroid dysfunction

11. Fine needle aspiration (FNA) cytology and ultrasound guided FNA

12. Thyroid hormone administration

13. Avoidance of radioactive iodine (RAI) and 131-I in pregnant women or
    women who are breast-feeding

14. Ensuring an adequate iodine intake

15. Measurement of urinary iodine concentration

16. Measurement of thyroid-stimulating hormone (TSH) levels in women
    known to be thyroid peroxidase antibody (TPO-Ab) positive

17. Postpartum screening for thyroiditis in women with type 1 diabetes
    mellitus

18. Annual TSH level in women with a history of postpartum thyroiditis
    (PPT)

19. Monitoring of TSH in asymptomatic women with an abnormal TSH who are
    not planning a subsequent pregnancy

20. Levothyroxine therapy for symptomatic women with an abnormal TSH who
    are planning pregnancy

#### MAJOR OUTCOMES CONSIDERED

-   Risk for and prevalence of thyroid dysfunction in pregnancy and the
    postpartum period

-   Incidence of fetal hyperthyroidism

-   Incidence of miscarriage and preterm delivery

-   Neuropsychological outcome of progeny

-   Adverse effects of antithyroid drugs on fetal development and fetal
    thyroid

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

The United States Preventive Services Task Force (USPSTF) grades the
overall evidence for a service on a three-point scale (good, fair, or
poor):

**Good**: Evidence includes consistent results from well designed, well
conducted studies in representative populations that directly assess
effects on health outcomes.

**Fair**: Evidence is sufficient to determine effects on health
outcomes, but the strength of the evidence is limited by the number,
quality, or consistency of the individual studies, generalizability to
routine practice, or indirect nature of the evidence on health outcomes.

**Poor**: Evidence is insufficient to assess the effects on health
outcomes because of limited number or power of studies, important flaws
in their design or conduct, gaps in the chain of evidence, or lack of
information on important health outcomes.

**Level of Evidence by GRADE System**

**High**: ++++ or +++O

**Moderate**: ++OO

**Low**: +OOO

**Very Low**: OOOO

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The guideline committee undertook to review all material on guideline
topics published in English during the past two decades, or earlier at
the working group\'s discretion. The committee concentrated on original
reports and largely excluded reviews from their references. At present,
with the exception of studies on iodide supplementation, only two
prospective, randomized intervention trials have been published in this
area. The guideline committee is aware of two large-scale prospective
intervention trials that are presently ongoing. Nevertheless, in the
last 15 years, many high-quality studies have modified older dogmas and
profoundly changed the ways in which these patients are managed. These
studies are most often prospective or retrospective clinical evaluations
of a particular patient population and matched groups of control women.
Such studies, when carefully performed, adequately matched, and
appropriately interpreted; provide the bulk of the evidence presented in
the guidelines.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

An international task force was created, under the auspices of The
Endocrine Society, to review the best evidence in the field and develop
evidence-based guidelines. Members of the task force included
representatives from The Endocrine Society, American Thyroid
Association, Association of American Clinical Endocrinologists, European
Thyroid Association, Asia and Oceania Thyroid Association, and the Latin
American Thyroid Society. The task force worked during 2 years to
develop the guidelines, had multiple phone conversations, and two 2-day
retreats. Upon completion of the guidelines, they were reviewed and
approved by all of the participants.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

The United States Preventive Services Task Force (USPSTF) grades its
recommendations (level A, B, C, D or I) on the basis of the strength of
evidence and magnitude of net benefits (benefits minus harms):

**A**: The USPSTF strongly recommends that clinicians provide (the
service) to eligible patients. *The USPSTF found good evidence that (the
service) improves important health outcomes and concludes that benefits
substantially outweigh harms.*

**B**: The USPSTF recommends that clinicians provide (the service) to
eligible patients. *The USPSTF found at least fair evidence that (the
service) improves important health outcomes and concludes that benefits
outweigh harms.*

**C**: The USPSTF makes no recommendation for or against routine
provision of (the service). *The USPSTF found at least fair evidence
that (the service) can improve health outcomes but concludes that the
balance of benefits and harms is too close to justify a general
recommendation.*

**D**: The USPSTF recommends against routinely providing (the service)
to asymptomatic patients. *The USPSTF found good evidence that (the
service) is ineffective or that harms outweigh benefits.*

**I**: The USPSTF concludes that the evidence is insufficient to
recommend for or against routinely providing (the service). *Evidence
that (the service) is effective is lacking, or poor quality, or
conflicting, and the balance of benefits and harms cannot be
determined.*

**Recommendation Level by GRADE System**

**1**: Strong

**2**: Moderate

Note: There are no equivalents in the GRADE system for the
recommendation levels C, D, and I used in the USPSTF system.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The manuscript was reviewed by the Society\'s Clinical Guideline\'s
Subcommittee (CGS), Clinical Affairs Committee, members of The Endocrine
Society, and members of each of the collaborating societies. Many
valuable suggestions were received and incorporated into the final
document. Each of the societies endorsed the guidelines.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions for the quality of the evidence based on the United States
Preventative Services Task Force \[USPSTF\] levels (good, fair, and
poor) and Grading of Recommendations Assessment, Development and
Evaluation \[GRADE\] levels (+OOO, ++OO, +++O, and ++++) and the
strength of the recommendation (USPSTF: A, B, C, D, I and GRADE: 1 or 2)
are provided at the end of the \"Major Recommendations\" field.

**Hypothyroidism and Pregnancy: Maternal and Fetal Aspects**

Both maternal and fetal hypothyroidism are known to have serious adverse
effects on the fetus. Therefore maternal hypothyroidism should be
avoided. For overt hypothyroidism (OH), The United States Preventive
Service Task Force (USPSTF) recommendation level is A; evidence is fair.
Targeted case finding is recommended at the first prenatal visit. The
USPSTF recommendation level is B; evidence is fair (GRADE 2 \| ++OO)
(Abalovich et al., 2002; Klein et al., 1991; Haddow et al., 1999;
Glinoer et al., 1994).

If hypothyroidism has been diagnosed before pregnancy, the guideline
panel recommends adjustment of the preconception thyroxine dose to reach
before pregnancy a thyroid-stimulating hormone (TSH) level not higher
than 2.5 mIU/liter. The USPSTF recommendation level is I; evidence is
poor (GRADE 2 \| +OOO) (Demers & Spencer, 2002; Baloch et al., 2003;
Panesar, Li, & Rogers, 2001).

The thyroxine dose often needs to be incremented by 4 to 6 weeks
gestation and may require a 30 to 50% increment in dosage. The USPSTF
recommendation level is A; evidence is good (GRADE 1 \| +++O) (Mandel et
al., 1990; Kaplan, 1992).

If OH is diagnosed during pregnancy, thyroid function tests should be
normalized as rapidly as possible. Thyroxine dosage should be titrated
to rapidly reach and thereafter maintain serum TSH concentrations of
less than 2.5 mI/liter in the first trimester (or 3 mIU/liter in second
and third trimesters) or to trimester-specific normal TSH ranges.
Thyroid function tests should be remeasured within 30 to 40 days. The
USPSTF recommendation level is A; evidence is good (GRADE 1 \| ++++)
(Soldin et al., 2004; Sapin, D\'Herbomez, & Schlienger, 2004; Panesar,
Li, & Rogers, 2001).

Women with thyroid autoimmunity (TAI) who are euthyroid in the early
stages of pregnancy are at risk of developing hypothyroidism and should
be monitored for elevation of TSH above the normal range. The USPSTF
recommendation level is A; evidence is fair (GRADE 1 \| +++O) (Alexander
et al., 2004; Glinoer et al., 1994).

Subclinical hypothyroidism (SCH) (serum TSH concentration above the
upper limit of the reference range with a normal free T~4~) has been
shown to be associated with an adverse outcome for both the mother and
offspring. Thyroxine treatment has been shown to improve obstetrical
outcome, but has not been proved to modify long-term neurological
development in the offspring. However, given that the potential benefits
outweigh the potential risks, the panel recommends thyroxine replacement
in women with subclinical hypothyroidism. For obstetrical outcome, the
USPSTF recommendation level is B; evidence is fair (GRADE 1 \| ++OO);
for neurological outcome, the USPSTF recommendation level is I; evidence
is poor (OOOO) (Abalovich et al., 2002; Leung et al., 1993; Casey et
al., 2005; Glinoer, 1997).

After delivery, most hypothyroid women need to decrease the thyroxine
dosage they received during pregnancy. The USPSTF recommendation level
is A; evidence is good (GRADE 1 \| ++++) (Caixas et al., 1999).

**Management of Maternal Hyperthyroidism: Maternal Aspects**

If a subnormal serum TSH concentration is detected during gestation,
hyperthyroidism must be distinguished from both normal physiology of
pregnancy and hyperemesis gravidarum because of the adverse effects of
OH on the mother and fetus. Differentiation of Graves\' disease from
gestational thyrotoxicosis is supported by presence of clinical evidence
of autoimmunity, a typical goiter, and presence of TSH-receptor
antibodies (TRAb). The USPSTF recommendation level is A; evidence is
good (GRADE 1 \| ++++) (Mestman, 2004; Goodwin, Montoro, & Mestman,
1992; Tan et al., 2002; Davis et al., 1989; Millar et al., 1994).

For OH due to Graves\' disease or thyroid nodules, antithyroid drug
(ATD) therapy should be either initiated (for those with new diagnoses)
or adjusted (for those with a prior history) to maintain the maternal
thyroid hormone levels for free T4 in the upper nonpregnant reference
range. The USPSTF recommendation level is A; evidence is good (GRADE 1
\| ++++) (Momotani et al., 1986; Mortimer et al., 1990).

Because available evidence suggests that methimazole (MMI) may be
associated with congenital anomalies, propylthiouracil (PTU) should be
used as a first-line drug, if available, especially during
first-trimester organogenesis. MMI may be prescribed if propylthiouracil
is not available, or if a patient cannot tolerate or has an adverse
response to propylthiouracil. The USPSTF recommendation level is B;
evidence is fair (GRADE 1 \| ++OO) (Mandel, Brent, & Larsen, 1994;
Martinez-Frias et al., 1992; Clementi et al., 1999; Johnsson, Larsson, &
Ljunggren, 1997; Di Gianantonio et al., 2001; Greenberg, 1987; Wilson et
al., 1998).

Subtotal thyroidectomy may be indicated during pregnancy as therapy for
maternal Graves\' disease if 1) a patient has a severe adverse reaction
to ATD therapy, 2) persistently high doses of ATD are required, or 3) a
patient is nonadherent to ATD therapy and has uncontrolled
hyperthyroidism. The optimal timing of surgery is in the second
trimester. The USPSTF recommendation level is I; evidence is poor (+OOO)
(Stice et al., 1984; Burrow, 1985; Brodsky et al., 1980).

There is no evidence that treatment of subclinical hyperthyroidism
improves pregnancy outcome, and treatment could potentially adversely
affect fetal outcome. The USPSTF recommendation level is I; evidence is
poor (+OOO) (Goodwin, Montoro, & Mestman, 1992; Tan et al., 2002; Casey
et al., 2006; Momotani et al., 1986).

**Management of Maternal Hyperthyroidism: Fetal Aspects**

Because thyroid receptor antibodies (thyroid receptor stimulating,
binding, or inhibiting antibodies) freely cross the placenta and can
stimulate the fetal thyroid, these antibodies should be measured by the
end of the second trimester in mothers with current Graves\' disease or
with a history of Graves\' disease and treatment with 131-I or
thyroidectomy before pregnancy, or with a previous neonate with Graves\'
disease. Women who have a negative TSH-receptor antibodies (TRAb) and do
not require ATD have a very low risk of fetal or neonatal thyroid
dysfunction. The USPSTF recommendation level is B; evidence is fair
(GRADE 1 \| +++O) (Nachum et al., 2003; Peleg et al., 2002; McKenzie &
Zakarija, 1992; Laurberg et al., 1998; Luton et al., 2005).

131-I should not be given to a woman who is or may be pregnant. If
inadvertently treated, the patient should be promptly informed of the
radiation danger to the fetus, including thyroid destruction if treated
after the 12th week of gestation. The USPSTF recommendation level is A;
evidence is good (GRADE 1 \| +OOO). There are no data for or against
recommending termination of pregnancy after 131-I exposure. The USPSTF
recommendation level is I; evidence is poor (+OOO) (Zanzonico, 1997;
Berg et al., 1998; Lowe, 2004; Bydder et al., 2005; Gorman, 1999).

In women with elevated TRAb or in women treated with ATD, fetal
ultrasound should be performed to look for evidence of fetal thyroid
dysfunction, which could include growth restriction, hydrops, presence
of goiter, advanced bone age, or cardiac failure. The USPSTF
recommendation level is B; evidence is fair (GRADE 1 \| +++O) (Nachum et
al., 2003; McKenzie & Zakarija, 1992; Laurberg et al., 1998; Mitsuda et
al., 1992; Luton et al., 2005).

Umbilical blood sampling should be considered only if the diagnosis of
fetal thyroid disease is not reasonably certain from the clinical data
and the information gained would change the treatment. The USPSTF
recommendation level is B; evidence is fair (GRADE 2 \| +OOO) (Davidson
et al., 1991; Nachum et al., 2003; Porreco & Bloch, 1990; Wenstrom et
al., 1990; Cohen et al., 2003; Fisher, 1997; Polak et al., 1997;
Wallace, Couch, & Ginsberg, 1995; Luton et al., 2005; Van Kamp et al.,
2005; Polak et al., 2004).

All newborns of mothers with Graves\' disease should be evaluated by a
medical care provider for thyroid dysfunction and treated if necessary.
The USPSTF recommendation level is B; evidence is fair (GRADE 1 \| +++O)
(McKenzie & Zakarija, 1992, Mitsuda et al., 1992; Luton et al., 2005).

**Gestational Hyperemesis and Hyperthyroidism**

Thyroid function tests should be measured in all patients with
hyperemesis gravidarum (5% weight loss, dehydration, and ketonuria). The
USPSTF recommendation level is B; evidence is poor (GRADE 2 \| +OOO)
(Goodwin, Montoro, & Mestman, 1992; Tan et al., 2002; Goodwin et al.,
1992; Lazarus, 2005).

Few women with hyperemesis gravidarum will require ATD treatment. The
USPSTF recommendation level is A; evidence is good (GRADE 1 \| ++++).
Overt hyperthyroidism believed to be due to coincident Graves\' disease
should be treated with ATDs. The USPSTF recommendation level is B;
evidence is fair (GRADE 1 \| ++OO). Gestational hyperthyroidism with
clearly elevated thyroid hormone levels (free T~4~ above the reference
range or total T~4~ \>150% of top normal pregnancy value and TSH \<0.1
microU/ml) and evidence of hyperthyroidism may require treatment as long
as clinically necessary. The USPSTF recommendation level is I; evidence
is poor (+OOO) (Goodwin, Montoro, & Mestman, 1992; Tan et al., 2002;
Goodwin et al., 1992; Lazarus, 2005).

**Autoimmune Thyroid Disease and Miscarriage**

Although a positive association exists between the presence of thyroid
antibodies and pregnancy loss, universal screening for antithyroid
antibodies, and possible treatment, cannot be recommended at this time.
As of this date, only one adequately designed intervention trial has
demonstrated a decrease in the miscarriage rate in thyroid
antibody-positive euthyroid women. The USPSTF recommendation level is C;
evidence is fair (GRADE \| +OOO) (Stagnaro-Green et al., 1990; De
Carolis et al., 2004; Sher et al., 1998).

**Thyroid Nodules and Cancer**

Fine needle aspiration (FNA) cytology should be performed for single or
dominant thyroid nodules larger than 1 cm discovered in pregnancy.
Ultrasound guided FNA may have an advantage for minimizing inadequate
sampling. The USPSTF recommendation level is B; evidence is fair (GRADE
1 \| +++O) (Kung et al., 2002; Mazzaferri & Jhiang, 1994; Moosa &
Mazzaferri, 1997; Vini et al., 1999).

When nodules are discovered in the first or early second trimester to be
malignant on cytopathological analysis or exhibit rapid growth,
pregnancy should not be interrupted but surgery should be offered in the
second trimester, before fetal viability. Women found to have cytology
indicative of papillary cancer or follicular neoplasm without evidence
of advanced disease, who prefer to wait until the postpartum period for
definitive surgery, may be reassured that most well-differentiated
thyroid cancers are slow growing and that surgical treatment soon after
delivery is unlikely to change prognosis. The USPSTF recommendation
level is B; evidence is fair (GRADE 1 \| ++OO) (Mazzaferri & Jhiang,
1994; Moosa & Mazzaferri, 1997; Vini et al., 1999; Herzon et al., 1994).

It is appropriate to administer thyroid hormone to achieve a suppressed
but detectable TSH in pregnant women with a previously treated thyroid
cancer, or a FNA positive for or suspicious for cancer, and those who
elect to delay surgical treatment until postpartum. High-risk patients
may benefit more from a greater degree of TSH suppression compared with
low-risk patients. The free T~4~ or total T~4~ levels should ideally not
be increased above the normal range for pregnancy. The USPSTF
recommendation level is I; evidence is poor (+OOO) (Rosen, Korman, &
Walfish, 1997).

Radioactive iodine (RAI) with 131-I should not be given to women who are
breast-feeding. The USPSTF recommendation level is B; evidence is fair.
Furthermore, pregnancy should be avoided for 6 months to 1 year in women
with thyroid cancer who receive therapeutic RAI doses to ensure
stability of thyroid function, and confirm remission of thyroid cancer.
The USPSTF recommendation level is B; evidence is fair (GRADE 1 \| ++OO)
(Choe & McDougall, 1994; Schlumberger et al., 1995; Chow et al., 2004).

**Iodine Nutrition during Pregnancy**

Women in the childbearing age should have an average iodine intake of
150 micrograms/day. During pregnancy and breast-feeding, women should
increase their daily iodine intake to 250 micrograms on average. The
USPSTF recommendation level A; evidence is good (GRADE 1\| +++O)
(Glinoer, 2001; Glinoer, 2003; World Health Organization, 2005;
Hollowell et al., 1998).

Iodine intake during pregnancy and breastfeeding should not exceed twice
the daily recommended nutrient intake (RNI) for iodine (i.e. 500
micrograms iodine/day). The USPSTF recommendation level is I; evidence
is poor (+OOO) (Glinoer, 2001; Glinoer, 2003; World Health Organization,
2005; Hollowell et al., 1998).

To assess the adequacy of the iodine intake during pregnancy in a
population, urinary iodine concentration (UIC) should be measured in a
representative cohort of the population. UIC should ideally range
between 150 and 250 micrograms/liter. The USPSTF recommendation level A;
evidence is good (GRADE 1 \| ++++) (Delange, 2004).

To reach the daily RNI for iodine, multiple means must be considered,
tailored to the iodine intake level in a given population. Different
situations must therefore be distinguished: 1) countries with iodine
sufficiency and/or with a well-established universal salt iodinization
(USI) program, 2) countries without a USI program or with an established
USI program where the coverage is known to be only partial, and 3)
remote areas with no accessible USI program and difficult socioeconomic
conditions. The USPSTF recommendation level is A; evidence is good
(GRADE 1 \| ++++) (Glinoer et al., 1995; Chaouki & Benmiloud, 1994;
Liesenkotter et al., 1996; Nohr & Laurberg, 2000; Romano et al., 1991).

**Postpartum Thyroiditis**

There are insufficient data to recommend screening of all women for
postpartum thyroiditis (PPT). The USPSTF recommendation level is I;
evidence is poor (+OOO) (Stagnaro-Green, 2002; Muller, Drexhage, &
Berghout, 2001).

Women known to be thyroid peroxidase antibody (TPO-Ab)-positive should
have a TSH performed at 3 and 6 months postpartum. The USPSTF
recommendation level is A; evidence is good (GRADE 1 \| +++O)
(Stagnaro-Green, 2002; Premawardhana et al., 2004).

The prevalence of PPT in women with type 1 diabetes mellitus (DM) is
3-fold greater than in the general population. Postpartum screening (TSH
determination) is recommended for women with type 1 DM at 3 and 6 months
postpartum. The USPSTF recommendation level is B; evidence is fair
(GRADE 1 \| ++OO) (McCanlies et al., 1998; Alvarez-Marfany et al., 1994;
Gerstein, 1993).

Women with a history of PPT have a markedly increased risk of developing
permanent primary hypothyroidism in the 5-to 10-year period following
the episode of PPT. An annual TSH level should be performed in these
women. The USPSTF recommendation level is A; evidence is good (GRADE 1
\| +++O) (Azizi, 2005; Othman et al., 1990; Premawardhana et al., 2000;
Tachi et al., 1988).

Asymptomatic women with PPT who have a TSH above the reference range but
less than 10 U/ml and who are not planning a subsequent pregnancy do not
necessarily require intervention, but should, if untreated, be
remonitored in 4 to 8 weeks. Symptomatic women and women with a TSH
above normal and who are attempting pregnancy should be treated with
levothyroxine. The USPSTF recommendation level is B; evidence is fair
(GRADE 1 \| ++OO) (Stagnaro-Green, 2002).

There is insufficient evidence to conclude whether an association exists
between postpartum depression (PPD) and either PPT or thyroid antibody
positivity (in women who did not develop PPT). The USPSTF recommendation
level is I; evidence is poor (Kuijpens et al., 1998; Lucas et al., 2000;
Cox, Murray, & Chapman, 1993; Stamp & Crowther, 1994; Harris et al.,
1992; Pop et al., 1993). However, as hypothyroidism is a potentially
reversible cause of depression, women with postpartum depression should
be screened for hypothyroidism and appropriately treated. The USPSTF
recommendation level is B; evidence is fair (GRADE 2 \| ++OO) (Cleare et
al., 1996).

**Screening for Thyroid Dysfunction during Pregnancy**

Although the benefits of universal screening for hypothyroidism may not
be justified by current evidence, as presented in *Sections 1 to 7* in
the original guideline document, we recommend case finding among the
following groups of women at high risk for thyroid dysfunction:

1.  Women with a history of hyperthyroid or hypothyroid disease, PPT, or
    thyroid lobectomy

2.  Women with a family history of thyroid disease

3.  Women with a goiter

4.  Women with thyroid antibodies (when known)

5.  Women with symptoms or clinical signs suggestive of thyroid
    underfunction or overfunction, including anemia, elevated
    cholesterol, and hyponatremia

6.  Women with type I diabetes

7.  Women with other autoimmune disorders

8.  Women with infertility should have screening with TSH as part of
    their infertility work-up

9.  Women with prior therapeutic head or neck irradiation

10. Women with a prior history of miscarriage or preterm delivery

The USPSTF recommendation level is B; evidence is fair (GRADE 1 \|
++OO).

**Definitions**:

**Strength of Evidence**

The United States Preventive Services Task Force (USPSTF) grades the
overall evidence for a service on a three-point scale (good, fair, or
poor):

**Good**: Evidence includes consistent results from well designed, well
conducted studies in representative populations that directly assess
effects on health outcomes.

**Fair**: Evidence is sufficient to determine effects on health
outcomes, but the strength of the evidence is limited by the number,
quality, or consistency of the individual studies, generalizability to
routine practice, or indirect nature of the evidence on health outcomes.

**Poor**: Evidence is insufficient to assess the effects on health
outcomes because of limited number or power of studies, important flaws
in their design or conduct, gaps in the chain of evidence, or lack of
information on important health outcomes.

**Strength of Recommendation**

**A**: The USPSTF strongly recommends that clinicians provide (the
service) to eligible patients. *The USPSTF found good evidence that (the
service) improves important health outcomes and concludes that benefits
substantially outweigh harms.*

**B**: The USPSTF recommends that clinicians provide (the service) to
eligible patients. *The USPSTF found at least fair evidence that (the
service) improves important health outcomes and concludes that benefits
outweigh harms.*

**C**: The USPSTF makes no recommendation for or against routine
provision of (the service). *The USPSTF found at least fair evidence
that (the service) can improve health outcomes but concludes that the
balance of benefits and harms is too close to justify a general
recommendation.*

**D**: The USPSTF recommends against routinely providing (the service)
to asymptomatic patients. *The USPSTF found good evidence that (the
service) is ineffective or that harms outweigh benefits.*

**I**: The USPSTF concludes that the evidence is insufficient to
recommend for or against routinely providing (the service). *Evidence
that (the service) is effective is lacking, or poor quality, or
conflicting, and the balance of benefits and harms cannot be
determined.*

**Evidence Level by GRADE System**

**High**: ++++ or +++O

**Moderate**: ++OO

**Low**: +OOO

**Very Low**: OOOO

**Recommendation Level by GRADE System**

**1**: Strong

**2**: Moderate

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=11283)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is specifically
stated for each recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate diagnosis and management of thyroid dysfunction during
pregnancy and postpartum

#### POTENTIAL HARMS

-   Subclinical hypothyroidism (SCH) (serum thyroid-stimulating hormone
    \[TSH\] concentration above the upper limit of the reference range
    with a normal free T4) has been shown to be associated with an
    adverse outcome for both the mother and offspring.

-   Overtreatment of the mother with thioamides can result in iatrogenic
    fetal hypothyroidism.

-   Treatment of maternal subclinical hyperthyroidism has not been found
    to improve pregnancy outcome and may risk unnecessary exposure of
    the fetus to antithyroid drugs (ATDs).

-   There have been reports of two distinct teratogenic patterns
    associated with methimazole (MMI): aplasia cutis and
    choanal/esophageal atresia.

-   Use of propranolol in late pregnancy has been associated with mild
    and transitory neonatal hypoglycemia, apnea, and bradycardia.
    Finally, there are case reports suggesting an association between
    propranolol use and intrauterine growth restriction, but this
    remains controversial.

-   Fetal exposure to high doses of radiation before organogenesis
    (before 4 to 6 weeks gestation) can lead to miscarriage or have no
    effect. Radiation exposure later in gestation can be associated with
    malformations, growth restriction, developmental delay and induction
    of malignancies.

-   Exposure after 12 weeks can induce thyroid ablation, requiring
    intrauterine thyroid hormone replacement and lifelong therapy for
    hypothyroidism.

-   If surgery is elected in pregnancy, it is best avoided in the first
    and third trimester. During the first trimester, there is concern
    over the possible teratogenic effects on the fetus, and surgery of
    any type is associated with increased early fetal loss. Surgery of
    any type in the third trimester is associated with a higher
    incidence of preterm labor. For cancer found early in pregnancy,
    surgery during the second trimester before fetal viability (\<22
    weeks) appears safe for the patient and the fetus. Fetal loss has
    been reported only in association with extensive neck exploration.

-   Excessive levels of iodine intake may potentially cause more
    disease. Furthermore, individuals must be identified who may have
    side effects from excessive iodine intake, such as patients with
    known or underlying autoimmune thyroid disorders or autonomous
    thyroid tissue.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   Because the experience with iodides is more limited, iodides should
    not be used as a first-line therapy for women with Graves\' disease,
    but they could be used transiently if needed in preparation for
    thyroidectomy.

-   Radioactive iodine (RAI) diagnostic tests and therapy are
    contraindicated during pregnancy, and all women who could
    potentially become pregnant should have a pregnancy test before
    131-I administration.

-   In addition, 131-I is contraindicated in breast-feeding mothers, and
    breast-feeding should cease if the exposure is unavoidable.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   Clinical Practice Guidelines are developed to be of assistance to
    endocrinologists by providing guidance and recommendations for
    particular areas of practice. The Guidelines should not be
    considered inclusive of all proper approaches or methods, or
    exclusive of others. The Guidelines cannot guarantee any specific
    outcome, nor do they establish a standard of care. The Guidelines
    are not intended to dictate the treatment of a particular patient.
    Treatment decisions must be made based on the independent judgment
    of healthcare providers and each patient\'s individual
    circumstances.

-   The Endocrine Society makes no warranty, express or implied,
    regarding the Guidelines and specifically excludes any warranties of
    merchantability and fitness for a particular use or purpose. The
    Society shall not be liable for direct, indirect, special,
    incidental, or consequential damages related to the use of the
    information contained herein.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Foreign Language Translations\
Patient Resources\
Quick Reference Guides/Physician Guides

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

The Endocrine Society. Management of thyroid dysfunction during
pregnancy and postpartum: an Endocrine Society clinical practice
guideline. Chevy Chase (MD): The Endocrine Society; 2007. 79 p. \[281
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007

#### GUIDELINE DEVELOPER(S)

The Endocrine Society - Disease Specific Society

#### SOURCE(S) OF FUNDING

The Endocrine Society

#### GUIDELINE COMMITTEE

Thyroid Dysfunction during Pregnancy and Postpartum Guideline Task Force

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Task Force Members*: Marcos Abalovich; Nobuyuki Amino; Linda A.
Barbour; Rhoda H. Cobin; Leslie J. De Groot; Daniel Glinoer; Susan J.
Mandel; Alex Stagnaro-Green

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

**Leslie J. DeGroot, MD**( chair) -- Significant Financial Interests:
None Declared; Governance: None Declared; Consultation or Advisement:
Occasional consultant with Abbott Laboratories; Grant or Other Research
Support: None Declared; Other: Grant support to Thyroidmanager.org Web
site by Abbott Laboratories.

**Marcos S. Abalovich, MD** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: None
Declared; Grant or Other Research Support: None Declared.

**Nobuyuki Amino, MD, PhD** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: None
Declared; Grant or Other Research Support: None Declared.

**Linda A. Barbour, MSPH, MD** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: None
Declared; Grant or Other Research Support: None Declared.

**Rhoda H. Cobin, MD** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: None
Declared; Grant or Other Research Support: None Declared.

**Daniel Glinoer, MD, PhD** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: None
Declared; Grant or Other Research Support: Ministère de la Communauté
Française (Administration Générale de l\'Enseignement et de la Recherche
Scientifique) within the framework of A.R.C. (Actions de Recherche
Concertée; convention N° 04/09-314).

**Susan J. Mandel, MD, MPH** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: King
Pharmaceuticals; Grant or Other Research Support: None Declared.

**Alex Stagnaro-Green, MD** -- Significant Financial Interests: None
Declared; Governance: None Declared; Consultation or Advisement: None
Declared; Grant or Other Research Support: None Declared.

#### ENDORSER(S)

American Association of Clinical Endocrinologists - Medical Specialty
Society\
American Thyroid Association - Professional Association\
Asian & Oceania Thyroid Association - Disease Specific Society\
European Thyroid Association - Disease Specific Society\
Latin AmericanThyroid Association - Disease Specific Society

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from [The
Endocrine
Society](http://www.endo-society.org/guidelines/Current-Clinical-Practice-Guidelines.cfm).

Print copies: Available from The Endocrine Society, c/o Bank of America,
P.O. Box 630721, Baltimore, MD 21263-0736; Phone: (301) 941.0210; Email:
<Societyservices@endo-society.org>

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   Management of thyroid dysfunction during pregnancy and postpartum:
    an Endocrine Society clinical practice guideline. Executive
    summary. 2007. 14 p. Electronic copies: Available in Portable
    Document Format (PDF) from [The Endocrine
    Society](http://www.endo-society.org/publications/guidelines/final/upload/Clinical-Guideline-Executive-Summary-Management-of-Thyroid-Dysfunction-during-Pregnancy-Postpartum.pdf).

Print copies: Available from The Endocrine Society, c/o Bank of America,
P.O. Box 630721, Baltimore, MD 21263-0736; Phone: (301) 941.0210; Email:
<Societyservices@endo-society.org>

#### PATIENT RESOURCES

The following are available:

-   Patient guide on maternal thyroid nodules and cancer before, during,
    and after pregnancy. Electronic copies: Available in Portable
    Document Format (PDF) from [The Endocrine
    Society](http://www.hormone.org/pdf/maternal_thy_nodules_guide.pdf).
    See the related QualityTool summary on the [Health Care Innovations
    Exchange Web
    site](http://www.innovations.ahrq.gov/content.aspx?id=1998).

-   Patient guide to the management of maternal hyperthyroidism before,
    during and after pregnancy. Electronic copies: Available in Portable
    Document Format (PDF) from [The Endocrine
    Society](http://www.hormone.org/pdf/hyperthyroid_women.pdf). See the
    related QualityTool summary on the [Health Care Innovations Exchange
    Web site](http://www.innovations.ahrq.gov/content.aspx?id=1982).

-   Patient guide to the management of maternal hypothyroidism before,
    during and after pregnancy. Electronic copies: Available in Portable
    Document Format (PDF) from [The Endocrine
    Society](http://www.hormone.org/pdf/hypothyroid_women.pdf). See the
    related QualityTool summary on the [Health Care Innovations Exchange
    Web site](http://www.innovations.ahrq.gov/content.aspx?id=1961).

-   Postpartum thyroiditis fact sheet. Electronic copies: Available in
    Spanish and English in Portable Document Format (PDF) from [The
    Endocrine
    Society](http://www.hormone.org/pdf/bilingual/bilingual_postpartum_thyroiditis.pdf).
    See the related QualityTool summary on the [Health Care Innovations
    Exchange Web
    site](http://www.innovations.ahrq.gov/content.aspx?id=1981).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI Institute on November 1, 2007.
The information was verified by the guideline developer on December 10,
2007.

#### COPYRIGHT STATEMENT

This is an author manuscript copyrighted by The Endocrine Society. This
may not be duplicated or reproduced, other than for personal use or
within the rule of \"Fair Use of Copyrighted Materials\" (section 107,
Title 17, U.S. Code) without permission of the copyright owner, The
Endocrine Society. From the time of acceptance following peer review,
the full text of this manuscript is made freely available by The
Endocrine Society at
<http://www.endo-society.org/guidelines/Current-Clinical-Practice-Guidelines.cfm>.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
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Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
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Readers with questions regarding guideline content are directed to
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Date Modified: 11/10/2008