RESUMEN
BACKGROUND: For asymptomatic individuals with a singleton pregnancy and a short cervix, vaginal progesterone significantly decreases the risk of PTB and improves perinatal outcomes. Cervical pessary is another option that has been evaluated with inconclusive results. There is; however, a lack of head-to-head comparisons between pessary and vaginal progesterone in this high risk population. OBJECTIVE: This randomized controlled trial (RCT) aims to compare the effectiveness of pessary and vaginal progesterone for the prevention of PTB in individuals with a singleton pregnancy and a CL ≤25 mm. STUDY DESIGN: We conducted an open-label, multi-center, RCT (NCT04300322) at three hospitals in Vietnam. Asymptomatic individuals with a singleton pregnancy and a CL ≤25mm (at 16 to 22 weeks) were randomized (1:1 ratio) to receive either an Arabin® cervical pessary or 200-mg vaginal progesterone daily. Primary outcome was PTB <37 weeks of any cause. Secondary outcomes were maternal and neonatal complications. We planned to recruit 804 women to assess a 10% absolute risk reduction in PTB <37 weeks (alpha-error 0.05, power 80%, 5% lost to follow-up). In view of the potential harm of pessary on perinatal mortality and PTB <28 weeks reported recently in two recent trials, our study was halted on June 2023. Analysis was by intention-to-treat. RESULTS: Between May 2020 and May 2023, we randomized 301 participants to pessary (N=150) or vaginal progesterone (N=151). Seven participants withdrew consent and 13 were lost to follow-up, resulting in 281 participants available for analysis (pessary group N=139; vaginal progesterone group N=142). The primary outcome, any PTB <37 weeks rate, occurred in 15.1% in the pessary group versus 14.1% in the vaginal progesterone group (RR 1.07; 95% CI, 0.61 to 1.9). PTB <28 weeks and perinatal death rates were higher in the pessary group, although these differences did not reach statistical significance (7.9% versus 4.2%, RR 1.87; 95% CI, 0.71 to 4.9 and 4.3% versus 2.8%, RR 1.5; 95% CI, 0.34 to 9.2; respectively). Vaginal discharge was significantly more frequent in the pessary group. CONCLUSION: In this prematurely halted RCT involving individuals with a singleton pregnancy and a CL ≤25 mm, neither cervical pessary nor vaginal progesterone was found to be superior in the prevention of PTB <37 weeks. However, vaginal progesterone was associated with non-significantly lower rates of PTB <34, <28 weeks and perinatal death.
RESUMEN
BACKGROUND: Although TSH suppression by elevated ß-hCG is essentially seen during first trimester, differences in TSH reference ranges between various countries have been reported. Physiologic changes during pregnancy may also influence FT4 assays. This study aims to establish method-specific reference intervals (RIs) of TSH, FT4, and FT3 in Vietnamese, first trimester pregnant women. METHODS: This cross-sectional study was conducted at My Duc Hospital, Ho Chi Minh, Vietnam. Women with singleton pregnancies in the first trimester and conceived naturally were included. Those with a history of thyroid disease, positive thyroid-specific autoantibodies, diffuse goiter or one thyroid nodule > 10 mm in size or ≥ 2 nodules detected by ultrasound, and taking medications affecting thyroid function were excluded. Serum TSH, FT4, and FT3 were measured by chemiluminescent detection technology on the Access 2 Immunoassay System (Beckman Coulter, Inc., USA). Intra- and interassay coefficients of variations (CV) were 3.6% and 4.4% for TSH, 5.4% and 6.1% for FT4, 6.6%, and 6.0% for FT3, respectively. The 2.5th and 97.5th percentiles were used to determine RIs. RESULTS: Between August 1, 2017, to December 1, 2018, there were 876 pregnant women who fulfilled inclusion and exclusion criteria. They had a mean age of 30.1 years, an average BMI of 21.3 kg/m2, and 77.3% of them were primigravida. The RIs for TSH, FT4 and FT3 were 0.17 - 2.35 mIU/L, 0.67 - 1.11 ng/dL and 2.82 - 3.90 pg/mL, respectively. CONCLUSIONS: Established RIs for TSH, FT4, and FT3 in Vietnamese women would help to reduce the misdiagnosis of gestational thyroid disorders.
