Antenatal screening for Hypothyroidism: Jordanian study (Part I) Omymah Zain Alddin AlRajabi,RN,MSN Rufaida College for Nursing, Midwifery & Paramedical MOH-Jordan Dr. Lourance Al Hadid, RN, MSN, CCNS, Ph.D. Al-Ghad International College for Applied Medical Sciences Head of Nursing Department, Tabouk Campus- Male, KSA

Background Hypothyroidism (Overt – Subclinical - Isolated hypothyroxinaemia) It is the 2nd most common health problem among maternal age women. Prevalence of normal iodized pregnancies is only 2.5% in countries like the USA; we don’t have accurate figures in Jordan. Prevention of hypothyroidism through early detection of is crucial to prevent complications like: Still birth, fetal brain damage, congenital malformation, Cognitive impairment , mental retardation & Autism??? Mainly….. Isolated hypothyroxinaemia complications Pre-eclampsia, infertility, miscarriage, and preterm delivery

Background Jordanian literature lacks studies on this topic. Therefore, this study explores the prevalence of hypothyroidism among pregnant women in Jordan. It also aims to conduct health screening related to the early detection of hypothyroidism .

Study objectives Estimate the prevalence of hypothyroidism among Jordanian pregnant women. Identify pregnant women at risk of developing hypothyroidism. Explore the significance of early screening of TSH in the 1st trimester of pregnancy. Develop recommendations to promote better healthcare policies concerning antenatal screening for Gestational Maternal Hypothyroidism.

Data Collection & Ethical Considerations This is part one of a larger multi-step study that includes all geographical regions of Jordan. This report though addresses only one city. Data were collected over 4 months using the modified pregnancy and thyroid survey (Vaidya et al., 2012). The approval to use this survey questionnaire has been granted from the authorized author through e mail request.

Data Collection &Ethical consideration, cont. Participation is voluntary, anonymous, and data collected were used by the researchers for research purposes only. Cover letter was attached to the study questionnaire explaining the purpose, significance and procedure of the study. The researchers explained all questions posed by the candidates.

Instrument Modified European Survey Questionnaire (Vaidya et al., 2012). It is composed of two parts: Part One: Demographic data, biophysical tests and measurements (BP, Pulse, Ht, Wt, BMI, Hgb, urine test for protein, and TSH level. Part Two: Screening items for the risk factors associated with hypothyroidism.

Definition of terms Isolated hypothyroxinemia: Normal maternal TSH concentration with low FT4 in the lower 5th or 10th percentile of the pregnancy reference range. Overt hypothyroidism(OH): Elevated TSH (>2.5mIU/L) with decreased FT4 according to pregnancy reference range; Women with TSH of 10.0mlU/L or more, irrespective of their FT4 considered OH. Subclinical hypothyroidism (SCH): Elevated TSH between (2.51st trimester, 3 in 2nd, & 3rd trimester up to 10 mIU/L) with normal FT4.

Study Guidelines This study adopts the American Thyroid Association (2011) guidelines: Pregnancy reference range for TSH….and FT4 1ST trimester TSH:0.1-2.5 mlU/L, FT4: 12.1-19.6 Pmol/L 2nd trimester TSH:0.2-3 mlU/L, FT4: 9.6-17 Pmol/L 3rd trimester TSH: 0.3-3 mlU/L FT4: 8.4-15.6 Pmol/L In Jordan, there are NO PREGNANCY REFRENCE RANGES ONLY adult reference range: TSH: 0.27-4.20 mIU/L FT4: 12-22 Pmol

Methods Design Sample Data collected A descriptive, correlational, cross-sectional was used. All detected cases were referred for treatment. Sample Purposive sample of 153 Jordanian pregnant women. Settings included one central hospital and one comprehensive health center at Al Rusyfa. Data collected Structured interview, antenatal routine lab tests, physical measurements and thyroid function tests.

Findings

Ch.ch of the respondents Minim Maxim Mean SD Age 16.00 45.00 28.222 6.397 No. of Preg. 1.00 11.00 3.739 2.194 Abortions .00 4.00 .712 1.030 No. of Deliveries 7.00 2.046 1.793 Ht 124.00 190.00 159.366 8.094 Wt 44.00 159.00 68.670 16.700 Hgb 8.00 120.00 12.074 8.887 FT4 27.02 12.934 2.685 BMI 17.30 51.42 26.961 5.560 TSH .01 10.50 2.536 1.814

Trimester Frequency Percent Cumulative Percent First 66 43.1 Second 32 20.9 64.1 Third 55 35.9 100.0

Prevalence of Hypothyroidism during Pregnancy (%) Thyroid Dysfunction National Adult Reference (trimester) Pregnancy Trimester Reference (trimester) 1st 2nd 3rd Total OH 3.27 3.9 Subclinical 1.31 7.85 5.23 9.15 18.3 Isolated Hypothyroxinimia 3.92 1.96 7.19 3.33 3.2 9.8 11.11 2.62 18.31 13.73 11.76 32 Confirmed OH on RX 11.11%

Prevalence of hypothyroidism during pregnancy According to Pregnancy Trimester Reference Nearly 1/3 were found to have one form of hypothyroidism, mainly SUBCLINICAL hypothyroidism (18.3%). According to National Adult Reference Nealry 1/5 were found to have one form of hypothyroidism. Comparison between both references went as follows: (Pregnancy Reference) 7.19% had % pregnancy reference) .(18.3% subclinical )

Condition Adult reference Pregnancy reference Clinical hypothyroidism (Overt) 3.27 % 3.9 % Isolated hypothyroxinemia 7.19 % 9.8 % Subclinical hypothyroidism 7.85 % 18.3 %

Correlations Data were tested for normality. Skweness and kurtosis were within the normal bounds. The study revealed the following correlational results: No correlation between TSH and BMI. No significant correlation between TSH and Hgb. No significant correlation between FT4 and Hgb. No correlation between TSH, FT4 and diet habits or iodinated salt

Slightly negative correlation between FT4 and BMI Pearson Correlation - .190* Sig. (2-tailed) .019 N 153 * Correlation is significant at the 0.05 level (2-tailed).

Previous history of thyroid disease and rheumatoid disease FT4 Range-Trimester Pearson Correlation - .327 * Sig. (2-tailed) .000 N 153 * Correlation is significant at the 0.01 level (2-tailed).

Previous history of Rheumatoid disease Rheumatoid diseases FT4 Range-Trimester Pearson Correlation -.211* Sig. (2-tailed) .009 N 153 * Correlation is significant at the 0.01 level (2-tailed).

Family history of thyroid disease FT4 Range-Trimester Pearson Correlation - .208* Sig. (2-tailed) .010 N 153 * Correlation is significant at the 0.01 level (2-tailed).

Previous history of repeated abortions FT4 Range-Trimester Pearson Correlation - .212* Sig. (2-tailed) .008 N 153 * Correlation is significant at the 0.01 level (2-tailed).

Gestational hypertension Previous history of Gestational hypertension Gestational hypertension FT4 Range-Trimester Pearson Correlation - .164* Sig. (2-tailed) .043 N 153 *Correlation is significant at the 0.05 level (2-tailed).

Post partum hemorrhage Previous history of Post partum hemorrhage Post partum hemorrhage FT4 Range-Trimester Pearson Correlation - .279* Sig. (2-tailed) .000 N 153 * Correlation is significant at the 0.01 level (2-tailed).

Post partum thyroiditis Previous history of Post partum thyroiditis Post partum thyroiditis FT4 Range-Trimester Pearson Correlation -.230* Sig. (2-tailed) .004 N 153 *Correlation is significant at the 0.01 level (2-tailed).

Conclusion TSH, FT4 adult reference ranges might not apply on pregnant women. Risky pregnancies and negative obstetrical outcomes may developed 2ndry to undiagnosed or misdiagnosed cases of hypothyroidism. Antenatal screening for hypothyroidism and trimester-reference range need to be adopted for safe maternal-child health.

Conclusion Women reported consuming iodine-added salt in this study, and yet it did not improve levels of TSH, FT3, and FT4. We assume that this result is related mainly to inadequate iodine intake. Thus, we recommend that iodine added to the table salt be improved to suite internationally acceptable levels. Additionally, other sources of iodine should be explained through educational sources (leaflets, brochures) to pregnant women.

Clinically, WHAT SHALL DO?

International Recommendations All pregnant women should be verbally screened at the initial prenatal visit for thyroid dysfunction problem & risk factors. SCH arising before conception or during gestation should be treated with levothyroxine. To date, NO study of intervention is available to demonstrate benefit from treating hypothyroxinaemic, but …………

it is associated with neuropsychological impairment in children Levothyroxine therapy may be considered in isolated hypothyroxinaemia detected in the 1st trim - it is associated with neuropsychological impairment in children Levothyroxine therapy is not recommended in isolated hypothyroxinaemia detected in the 2nd and 3rd trim.s. Trimester-specific reference ranges for TSH and T4 (total or free) should be established in each antenatal hospital setting. Local variations may occur.

International recommendations If TSH trimester-specific reference ranges are not available, the following limits are recommended: 1st trimester:TSH: 0.1- 2.5 mU/L 2nd trimester: 0.2 - 3.0 mU/L 3rd trimester: 0.3 - 3.5 mU/L T4 and FT4 assays are both suitable for thyroid function testing in pregnancy. TSH should be measured at the beginning of pregnancy, if it is elevated.

International recommendations FT 4 and TPOAb should be determined for SCH or overt hypothyroidism to be diagnosed. The daily iodine intake during pregnancy and lactation should be at least 250 μg and should not exceed500 μg. Iodine intake by supplementing euthyroid pregnant and lactating women with formulas containing 150 μg of iodine/day, ideally before conception. Effectiveness and side effects of iodine prophylaxis together with or without levothyroxine Rx in sub clinical hypothyroid women should be assessed.

International recommendations SCH arising before conception or during gestation should be treated with levothyroxine T4 The recommended Rx of maternal hypothyroidism is oral levothyroxine The use of levothyroxine-T3 combinations or desiccated thyroid is not recommended. The goal of levothyroxine Rx is to normalize maternal serum TSH values within the trimester-specific pregnancy reference range.

In newly diagnosed women with SCH in pregnancy, a starting dose of 1 In newly diagnosed women with SCH in pregnancy, a starting dose of 1.20 μg/kg.day is advised. Women with SCH and those with overt hypothyroidism desiring pregnancy should take levothyroxine in a single dose to ensure a TSH level of < 2.5 mU/l. (2S)

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