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BACKGROUND: Short cervical length measured during the second trimester of pregnancy is an important risk factor for spontaneous preterm birth (sPTB). The aim of this study is to identify the association between mid-pregnancy cervical length (CL) and gestational age at birth in asymptomatic singleton pregnant women. METHODS: This is a prospective cohort study involving singleton pregnant women who participated in the screening phase of a Brazilian multicenter randomized controlled trial (P5 trial) between July 2015 and March 2019. Transvaginal ultrasound to measure CL was performed from 18 to 22 + 6 weeks. Women with CL ≤ 30 mm received vaginal progesterone (200 mg/day) until 36 weeks' gestation. For this analysis we considered all women with CL ≤ 30 mm receiving progesterone and a random selection of women with CL > 30 mm, keeping the populational distribution of CL. We obtained prognostic effectiveness data (area under receive operating characteristic curve (AUC), sensitivity and specificity and estimated Kaplan-Meier curves for preterm birth using different CL cutoff points. RESULTS: We report on 3139 women and identified a negative association between cervical length and sPTB. CL ≤ 25 mm was associated with sPTB < 28, sPTB < 34 and sPTB < 37 weeks, whereas a CL 25-30 mm was directly associated with late sPTB. CL by transvaginal ultrasound presented an AUC of 0.82 to predict sPTB < 28 weeks and 0.67 for sPTB < 34 weeks. Almost half of the sPTB occurred in nulliparous women and CL ≤ 30 mm was associated with sPTB at < 37 weeks (OR = 7.84; 95%CI = 5.5-11.1). The number needed to screen to detect one sPTB < 34 weeks in women with CL ≤ 25 mm is 121 and we estimated that 248 screening tests are necessary to prevent one sPTB < 34 weeks using progesterone prophylaxis. CONCLUSIONS: CL measured by transvaginal ultrasound should be used to predict sPTB < 34 weeks. Women with CL ≤ 30 mm are at increased risk for late sPTB.

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OBJECTIVE: Since there are populational differences and risk factors that influence the cervical length, the aim of the study was to construct a populational curve with measurements of the uterine cervix of pregnant women in the second trimester of pregnancy and to evaluate which variables were related to cervical length (CL) ≤25 mm. MATERIALS AND METHODS: This was a multicenter cross-sectional study performed at 17 hospitals in several regions of Brazil. From 2015 to 2019, transvaginal ultrasound scan was performed in women with singleton pregnancies at 18 0/7 to 22 6/7 weeks of gestation to measure the CL. We analyzed CL regarding its distribution and the risk factors for CL ≤25 mm using logistic regression. RESULTS: The percentage of CL ≤ 25mm was 6.67%. Shorter cervices, when measured using both straight and curve techniques, showed similar results: range 21.0-25.0 mm in straight versus 22.6-26.0 mm in curve measurement for the 5th percentile. However, the difference between the two techniques became more pronounced after the 75th percentile (range 41.0-42.0 mm straight x 43.6-45.0 mm in curve measurement). The risk factors identified for short cervix were low body mass index (BMI) (OR: 1.81 CI: 1.16-2.82), higher education (OR: 1.39 CI: 1.10-1.75) and personal history ([one prior miscarriage OR: 1.41 CI: 1.11-1.78 and ≥2 prior miscarriages OR: 1.67 CI: 1.24-2.25], preterm birth [OR: 1.70 CI: 1.12-2.59], previous low birth weight <2500 g [OR: 1.70 CI: 1.15-2.50], cervical surgery [OR: 4.33 CI: 2.58-7.27]). By contrast, obesity (OR: 0.64 CI: 0.51-0.82), living with a partner (OR: 0.76 CI: 0.61-0.95) and previous pregnancy (OR: 0.46 CI: 0.37-0.57) decreased the risk of short cervix. CONCLUSIONS: The CL distribution showed a relatively low percentage of cervix ≤25 mm. There may be populational differences in the CL distribution and this as well as the risk factors for short CL need to be considered when adopting a screening strategy for short cervix.

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OBJECTIVE: To test the effectiveness of cervical pessary in addition to vaginal progesterone for the prevention of preterm birth in women with midpregnancy short cervixes. METHODS: We performed a multicenter, open-label, randomized controlled trial in 17 perinatal centers. Asymptomatic women with singleton or twin pregnancies and cervical lengths of 30 mm or less, measured at 18 0/7-22 6/7 weeks of gestation, were randomized to cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesterone-only group) (200 mg/day). Treatments were used from randomization to 36 weeks of gestation or delivery. The primary outcome was a composite of neonatal mortality and morbidity. Secondary outcomes were delivery before 37 weeks and before 34 weeks of gestation. Analysis was performed according to intention to treat. RESULTS: Between July 9, 2015, and March 29, 2019, 8,168 women were screened, of whom 475 were randomized to pessary and 461 to progesterone only. The composite perinatal outcome occurred in 19.2% (89/463) of the women in the pessary group compared with 20.9% (91/436) of the women in the progesterone-only group (adjusted risk ratio [aRR] 0.88, 95% CI 0.69-1.12). Delivery rates before 37 weeks of gestation were 29.1% compared with 31.4% (aRR 0.86, 95% CI 0.72-1.04); delivery rates before 34 weeks were 9.9% compared with 13.9% (aRR 0.66, 95% CI 0.47-0.93). Women in the pessary group had more vaginal discharge (51.6% [245/476] vs 25.4% [117/479] [P<.001]), pain (33.1% [157/476] vs 24.1% [111/479] [P=.002]), and vaginal bleeding (9.7% [46/476] vs 4.8% [22/479] [P=.004]). CONCLUSION: In asymptomatic women with short cervixes, the combination of pessary and progesterone did not decrease rates of neonatal morbidity or mortality when compared with progesterone only. CLINICAL TRIAL REGISTRATION: Brazilian Clinical Trial Registry (ReBec), UTN:U1111-1164-2636.

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OBJECTIVE: To investigate the characteristics of women who had preterm birth (PTB) and related outcomes according to ethnicity. METHODS: A secondary analysis of a multicenter cross-sectional study conducted in Brazil. Women who had PTB were classified by self-report as white and non-white. Clinical, pregnancy, and maternal data were collected through postpartum interviews and reviews of medical charts. The sociodemographic, obstetric and clinical characteristics of the women, as well as the mode of delivery and the neonatal outcomes among different ethnic groups were compared through a bivariate analysis. RESULTS: Of the 4,150 women who had PTB, 2,317 (55.8%) were non-white, who were more likely: to be younger than 19 years of age (prevalence ratio [PR]: 1.05; 95% confidence interval [95%CI]: 1.01-1.09); to be without a partner; to live on low income; to have lower levels of schooling; to have ≥ 2 children; to perform strenuous work; to be from the Northeastern region of Brazil rather than the from Southern region; to have a history of ≥ 3 deliveries; to have an interpregnancy interval < 12 months; to have pregnancy complications such as abortion, PTB, preterm premature rupture of membranes (pPROM), and low birth weight; to initiate antenatal care (ANC) visits in the second or third trimesters; to have have an inadequate number of ANC visits; to be under continuous overexertion; to smoke in the first and second or third trimesters; and to have anemia and gestational hypertension. The maternal and neonatal outcomes did not differ between the groups, except for the higher rate of low birth weight (73.7% versus 69.0%) in infants born to non-white women, and the higher rate of seizures (4.05% versus 6.29%) in infants born to white women. CONCLUSION: Unfavorable conditions were more common in non-whites than in whites. Proper policies are required to decrease inequalities, especially in the context of prematurity, when women and their neonates have specific needs.

OBJETIVO: Investigar as características das mulheres com parto pré-termo e os respectivos resultados de acordo com a etnia. MéTODOS: Uma análise secundária de um estudo de corte transversal multicêntrico no Brasil. Mulheres com parto pré-termo foram classificadas por autodefinição como brancas ou não brancas. Dados maternos, clínicos, e da gestação foram coletados por entrevista pós-parto e revisão de prontuários. As características sociodemográficas, obstétricas e clínicas das mulheres, o tipo de parto, e os resultados neonatais dos grupos étnicos foram comparados por análise bivariada. RESULTADOS: Das 4.150 mulheres que tiveram parto pré-termo, 2.317 (55,8%) eram não brancas, que com mais frequência: eram menores de 19 anos de idade (razão de prevalência [RP]: 1,05; intervalo de confiança de 95% [IC95%]: 1,01­1,09); não tinham parceiro; eram de baixa renda; tinham baixa escolaridade; tinham ≥ 2 filhos; realizavam trabalho extenuante; provinham mais do Nordeste do que do Sul; tinham histórico de ≥ 3 partos; tinham intervalo interpartal < 12 meses; e tiveram complicações gestacionais como aborto, parto pré-termo, rotura prematura de membranas pré-termo (RPM-PT) e baixo peso ao nascimento; iniciaram as consultas de pré-natal no segundo ou terceiro trimestres; compareceram a um número inadequado de consultas; viviam sob contínua exaustão; fumaram no primeiro e segundo ou terceiro trimestres; e tiveram anemia e hipertensão gestacional. Os resultados maternos e neonatais não diferiram entre os grupos, exceto pela maior taxa de baixo peso ao nascimento (73,7% versus 69,0%) entre as crianças das mulheres não brancas, e e a maior taxa de convulsões (4,05% versus 6,29%) entre as das brancas. CONCLUSãO: Condições desfavoráveis foram mais comuns entre não brancas do que entre brancas. Políticas apropriadas são necessárias para diminuir as diferenças, especialmente no contexto da prematuridade, quando mulheres e seus neonatos têm necessidades específicas.

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Spontaneous preterm birth (sPTB) is a major pregnancy complication involving biological, social, behavioural and environmental mechanisms. Workload, shift and intensity may play a role in the occurrence of sPTB. This analysis is aimed addressing the effect of occupational activities on the risk for sPTB and the related outcomes. We conducted a secondary analysis of the EMIP study, a Brazilian multicentre cross-sectional study. For this analysis, we included 1,280 singleton sPTB and 1,136 singleton term birth cases. Independent variables included sociodemographic characteristics, clinical complications, work characteristics, and physical effort devoted to household chores. A backward multiple logistic regression analysis was applied for a model using work characteristics, controlled by cluster sampling design. On bivariate analysis, discontinuing work during pregnancy and working until the 7th month of pregnancy were risks for premature birth while working during the 8th - 9th month of pregnancy, prolonged standing during work and doing household chores appeared to be protective against sPTB during pregnancy. Previous preterm birth, polyhydramnios, vaginal bleeding, stopping work during pregnancy, or working until the 7th month of pregnancy were risk factors in the multivariate analysis. The protective effect of variables compatible with exertion during paid work may represent a reverse causality. Nevertheless, a reduced risk associated with household duties, and working until the 8th-9th month of pregnancy support the hypothesis that some sort of physical exertion may provide actual protection against sPTB.

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Preterm birth is the major contributor for neonatal and under-five years mortality rates and also accounts for a short- and long-term adverse consequences up to adulthood. Perinatal outcomes may vary according to lots of factors as preterm subtype, late prematurity, which account for the vast majority of cases, country and population characteristics. An under-recognition of the perinatal outcomes and its associated factors might have underpowered strategies to provide adequate care and prevent its occurrence. We aim to estimate the frequency of maternal and perinatal outcomes in women with different categories of preterm and term births, factors associated with poorer perinatal outcomes and related management interventions. A multicentre prospective cohort in five maternities in Brazil between 2015 and 2018. Nulliparous low-risk women with singletons were included. Comprehensive data were collected during three antenatal visits (at 19-21weeks, 27-29 weeks and 37-39 weeks). Maternal and perinatal outcomes were also collected according to maternal and neonatal medical records. Women who had spontaneous (sPTB) and provider-initiated (pi-PTB) preterm birth were compared to those who had term birth. Also, late preterm birth (after 34 weeks), and early term (37-38 weeks) were compared to full term birth (39-40 weeks). Bivariate analysis estimated risk ratios for maternal and adverse outcomes. Finally, a multivariate analysis was conducted to address factors independently associated with any adverse perinatal outcome (APO). In total, 1,165 women had outcome data available, from which 6.7% had sPTB, 4.0% had pi-PTB and 89.3% had a term birth. sPTB and pi-PTb were associated with poorer perinatal outcomes, as well as late sPTB, late pi-PTB and early term neonates. pi-PTB (RRadj 8.12, 95% CI [2.54-25.93], p-value 0.007), maternal weight gain between 20 and 27 weeks

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The detection of Zika virus (ZIKV) in immunoprivileged anatomical sites, potential sites for viral persistence, may guide the confirmation of undefined cases of ZIKV infection and also bring to light unknown pathways of viral transmission. Thus, this study aimed to characterize ZIKV infection in stratified, standardized placental samples in women with exanthematic febrile manifestations during pregnancy and compare findings to the standard investigation protocol of official health agencies. To this end, a case series of placental findings within a prospective cohort study was conducted over a period of 24 months. Serum/urine were obtained at the time of clinical case identification. Placental sampling was performed following standard investigation protocol (samples of 1.0 cm sent to a reference laboratory) and in a systematic way at various regions, such as chorionic plate, chorionic villi, basal plate, amniotic membrane, and umbilical cord, for subsequent ZIKV identification and quantification. Clinical information was obtained and histological preparation with hematoxylin-eosin staining for morphological evaluation was performed. This case series included 17 placentas systematically collected. Of these, 14 were positive by qRT-PCR for ZIKV, 5 in the umbilical cord, 7 in the amniotic membrane, 7 in the chorionic plate, 13 in the chorionic villi, and 7 in the basal plate, whereas none were reported by the reference laboratory. The most common morphological and anatomopathological findings were increased stromal cellularity, villitis, calcification, maternal vascular malperfusion, placental hypoplasia, and maternal-fetal hemorrhage (intervillous thrombi). Seven women presented positive testing for ZIKV in serological and/or molecular tests during gestation in urine. While viral quantification in urine ranged from 101 to 103 FFU eq/ml, that in different placental regions ranged from 103 to 108 FFU eq/g. Thus, ZIKV can infect different regions of the placenta and umbilical cord of pregnant women, showing that the systematic collection and adequate storage of the placenta is fundamental for the detection of ZIKV in this organ. The detection of ZIKV in the placenta after several months of initial symptoms suggests that this tissue may be a site for viral persistence during pregnancy.

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OBJECTIVE: To compare maternal and perinatal outcomes between twin and single preterm births (PTB) and associated factors. METHODS: A cross-sectional multicenter study was conducted in Brazil with 4046 PTBs from April 2011 to July 2012. Causes of PTB, use of tocolytics, corticosteroids, and antibiotics in twin and single pregnancies, and factors possibly associated with twinning were evaluated using χ2 tests. Maternal and perinatal outcomes were assessed with prevalence ratios (PR). RESULTS: The main cause of PTB in twin pregnancy was spontaneous onset of preterm labor. Tocolytics were more frequently used in twins (26.9% vs 20.2%). Factors associated with PTB in twins were: maternal age >25 years (62.3% vs 53.4%); interpregnancy interval >3 years (39.0% vs 33.4%); no history of PTB (87.4% vs 79.6%); no previous maternal conditions (78.0% vs 73.3%); no alcohol abuse (88.5% vs 84.3%); no drug addiction (97.5% vs 94.5%); and >6 prenatal visits (46.5% vs 37.6%). Twin pregnancies run a 46% higher risk of cesarean delivery, while first and second twins face a 20% higher risk of low birth weight. Twin pregnancies run increased risks for admission to the NICU, cerebral hemorrhage, necrotizing enterocolitis, and any adverse perinatal outcome. CONCLUSION: Preterm twin birth is associated with low birth weight and worse neonatal outcomes.

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The objective of this study was to determine incidence and risk factors associated with spontaneous preterm birth (sPTB). It was a prospective multicentre cohort study performed in five Brazilian referral maternity hospitals and enrolling nulliparous women at 19-21 weeks. Comprehensive maternal data collected during three study visits were addressed as potentially associated factors for sPTB. Bivariate and multivariate analysis estimated risk ratios. The main outcomes measures were birth before 37 weeks due to spontaneous preterm labour or premature rupture of membranes (sPTB). The comparison group was comprised of women with term births (≥37weeks). Outcome data was available for 1,165 women, 6.7% of whom had sPTB, 16% had consumed alcohol and 5% had used other illicit drugs during the first half of pregnancy. Current drinking at 19-21 weeks (RR 3.96 95% CI [1.04-15.05]) and a short cervix from 18-24 weeks (RR 4.52 95% CI [1.08-19.01]) correlated with sPTB on bivariate analysis. Increased incidence of sPTB occurred in underweight women gaining weight below quartile 1 (14.8%), obese women gaining weight above quartile 3 (14.3%), women with a short cervix (<25 mm) at 18-24 weeks (31.2%) and those with a short cervix and vaginal bleeding in the first half of pregnancy (40%). Cervical length (RRadj 4.52 95% CI [1.08-19.01]) was independently associated with sPTB. In conclusion, the incidence of sPTB increased in some maternal phenotypes, representing potential groups of interest, the focus of preventive strategies. Similarly, nulliparous women with a short cervix in the second trimester require further exploration.

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BACKGROUND: Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. METHODS: This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. DISCUSSION: In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. TRIAL REGISTRATION: Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111-1164-2636, 2014/11/18.

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