Progression of Gestational Subclinical Hypothyroidism and Hypothyroxinemia to Overt Hypothyroidism After Pregnancy: Pooled Analysis of Data from Two Randomized Controlled Trials
Authors' conclusion
SH is associated with higher rates of overt hypothyroidism or thyroid replacement therapy within 5 years of delivery than is HT when these conditions are diagnosed in the first half of pregnancy.
Study context
- Population
- Pregnant individuals with subclinical hypothyroidism (SH) or hypothyroxinemia (HT) diagnosed between 8 and 20 weeks gestation, randomized to placebo in two multicenter treatment trialsplacebo groups of two RCTs
- Participants
- 338 vs 261
- Comparison
- Gestational SH vs HT
- SHn = 338
- HTn = 261reference
- Primary endpoint
- Incidence of overt hypothyroidism (TSH ≥4.0 mU/L with fT4 <0.86 ng/dL)
- Follow-up
- 1 and 5 years after delivery
Methodological detailspooled analysis, multicenter, placebo groups only
- Pooled analysis
- Multicenter
- Placebo groups only
Primary result
As reported in the abstract
Overt hypothyroidism · year 1
P < 0.001
Further findings
Overt hypothyroidism · year 5 · more common with SH
P < 0.001
| Outcome | OR (CI) | |
|---|---|---|
| Overt hypothyroidism in SH, TPO >50vs ≤50 IU/mL · year 1 | 5.3 (2.6–10.7) | |
| Overt hypothyroidism in SH, TPO >50vs ≤50 IU/mL · year 5 | 5.4 (2.8–10.6) | |
| Overt hypothyroidism in HT, TPO >50vs ≤50 IU/mL · 1 yearNo differences | 3.9 (0.43–36.1) | |
| Overt hypothyroidism in HT, TPO >50vs ≤50 IU/mL · year 5 | 13.4 (2.1–84.1) | |
| 0.050.21520Odds ratio (log scale) |
- Overt hypothyroidism in SH, thyroid peroxidase (TPO) >50 vs ≤50 IU/mL: TPO >50 IU/mL 26.7%
- Overt hypothyroidism in SH, TPO >50 vs ≤50 IU/mL: TPO ≤50 IU/mL 6.5%
- Overt hypothyroidism in SH, TPO >50 vs ≤50 IU/mL: TPO >50 IU/mL 30.5%
- Overt hypothyroidism in SH, TPO >50 vs ≤50 IU/mL: TPO ≤50 IU/mL 7.5%
- Overt hypothyroidism in HT, TPO >50 vs ≤50 IU/mL: TPO >50 IU/mL 10%
- Overt hypothyroidism in HT, TPO >50 vs ≤50 IU/mL: TPO ≤50 IU/mL 2.8%
- Overt hypothyroidism in HT, TPO >50 vs ≤50 IU/mL: TPO >50 IU/mL 20%
- Overt hypothyroidism in HT, TPO >50 vs ≤50 IU/mL: TPO ≤50 IU/mL 1.8%
Progression by TSH level
- Progression more common with TSH values >10 mIU/mL
Original publication
Progression of Gestational Subclinical Hypothyroidism and Hypothyroxinemia to Overt Hypothyroidism After Pregnancy: Pooled Analysis of Data from Two Randomized Controlled Trials. Thyroid. Published 31 July 2024. doi:10. 1089/ thy. 2023. 0616
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