PROMPT: Prospective Meta-analysis for Pessary Trials Study Protocol.

OBJECTIVE: Preterm birth, defined as birth before 37 weeks of gestation, is a leading cause of perinatal and infant mortality throughout the world. Preterm birth is also associated with long-term neurological disabilities and other significant health issues in children. A short cervix in the second trimester has been noted to be one of the strongest predictors of subsequent spontaneous preterm birth in both singleton and multiple pregnancies. Some studies have shown that cervical support in the form of an Arabin pessary lowers the risk of preterm birth in women with a singleton gestation and short cervical length; however, other studies have conflicting results. Our objective was to form an international collaborative of planned or ongoing randomized trials of pessary in singleton and twin gestations with a short cervix. STUDY DESIGN: In November 2014, an international group of investigators, who had initiated or were planning randomized trials of pessary for pregnant people with a short cervix and singleton or twin gestation to prevent preterm birth, formed a collaboration to plan a prospective individual patient data (IPD) meta-analysis of randomized trials (PROspective Meta-analysis of Pessary Trials [PROMPT]). The PROMPT investigators agreed on meta-analysis IPD hypotheses for singletons and twins, eligibility criteria, and a set of core baseline and outcome measures. The primary outcome is a composite of fetal death or preterm delivery before 32 weeks' gestation. Secondary outcomes include maternal and neonatal morbidities. The PROMPT protocol may be viewed as a written agreement among the study investigators who make up the PROMPT consortium (PROSPERO ID# CRD42018067740). RESULTS: Results will be published in phases as the individual participating studies are concluded and published. Results of the first phase of singleton and twin pessary trials are expected to be available in late 2022. Updates are planned as participating trials are completed and published. KEY POINTS: · Short cervical length predicts preterm birth.. · Results of prior cervical pessary trials are mixed.. · Meta-analysis of pessary trials protocol..

Comparison of contraceptive sales before and during the COVID-19 pandemic in Brazil.

OBJECTIVE: The aim of the study was to assess the impact of the COVID-19 pandemic on sales of modern contraceptive methods in Brazil. METHODS: Monthly sales data were analysed of short-acting reversible contraceptive methods and long-acting reversible contraceptive (LARC) methods (implants and intrauterine contraception) and COVID-19 related deaths. Contraceptive methods were grouped as follows: emergency contraception (EC); oral contraception, vaginal rings and transdermal patches; injectable contraception; LARC methods including the copper intrauterine device (Cu-IUD); and LARC methods excluding the Cu-IUD. RESULTS: Contraceptive sales showed a non-significant increase in 2020 compared with the previous year; average sales ranged from 12.8 to 13.0 million units per month. Sales of injectable contraceptives increased between March and June 2020 and EC pills between June and July 2020; the variation in sales of pills, patches and rings was not significant. Sales of the levonorgestrel-releasing intrauterine system (LNG-IUS) and the etonogestrel (ENG) implant showed three patterns: a decrease in sales between February and May 2020 (coinciding with the closure of family planning services), an increase in sales after May 2020 (coinciding with the first COVID-19-related deaths), and a further increase in sales after July 2020 (corresponding to the increasing number of deaths from COVID-19). CONCLUSION: The COVID-19 pandemic has disrupted the Brazilian health care system. Since many family planning clinics were closed, sales of most modern contraceptives fell during 2020; however, the increase in sales of the LNG-IUS and ENG implant in the private sector indicates inequitable access to modern contraceptive methods.

"Preterm birth risk, me?" Women risk perception about premature delivery - a qualitative analysis.

BACKGROUND: Risk perception is based on collective indicators, but it is influenced by the individual's self-perception of his health-disease process. This study aims to investigate the risk perception of pregnant women who were identified as high-risk for premature birth and to seek strategies for better management of such cases. METHODS: This is a cross-sectional study where women who had completed their participation in P5 trial were contacted and invited to answer a structured questionnaire with open questions. Data were collected by telephone and analyzed using thematic analysis. The analysis categories were defined, and all the answers were reviewed, categorized, grouped, and a descriptive summary was prepared. RESULTS: Two hundred eight Brazilian women have participated. Three categories were identified: (1) Risk perception mediated by health professionals; (2) Self-perception of risk through personal experiences and relationships; (3) Perception of treatment success. After receiving an explanation from a health professional about short cervix and premature birth, women understood the risk of premature delivery, recognizing the importance of early diagnosis to prevent premature birth. Unsuccessful previous experiences in prior pregnancies influenced women's risk perception. Patients believed in the success of the treatment performed, placing their hopes on the treatment even without research guarantees about benefits. CONCLUSIONS: Pregnant women's risk perception regarding prematurity is based partly on personal and family experiences but mainly on information given by health professionals. The risk perception about preterm birth may contribute to healthy pregnancy, guiding necessary interventions and preventing adverse outcomes. Prevention studies on prematurity should thus focus on neonatal outcomes.

Long-Term Consequences of Severe Maternal Morbidity on Infant Growth and Development.

OBJECTIVE: Severe maternal morbidity (SMM) is already known to be associated with adverse neonatal outcomes, however, its association with long-term deficits of weight and height, and impairment in neurodevelopment among children was not yet fully assessed. We aim to evaluate whether SMM has repercussions on the weight and height-for-age and neurodevelopmental status of the child. METHODS: A retrospective cohort analysis with women who had SMM events in a tertiary referral center in Brazil. They were compared to a control group of women who had not experienced any SMM. Childbirth and perinatal characteristics, weight and height-for-age deficits and neurodevelopmental impairment suspicion by Denver II Test were comparatively assessed in both groups using RR and 95% CI. Multiple regression analysis was used addressing deficit of weight-for-age, height-for-age and an altered Denver Test, estimating their independent adjusted RR and 95% CI. RESULTS: 634 women with perinatal outcomes available (311 with SMM and 323 without) and 571 children were assessed. Among women with SMM, increased rates in perinatal deaths, Apgar lower than 7 at five minutes, shorter breastfeeding period, preterm birth (49.0% × 11.1%), low birthweight (45.8% × 11.5%), deficits of weight-for-age [RR 3.11 (1.60-6.04)] and height-for-age [RR 1.52 (1.06-2.19)] and altered Denver Test [RR 1.5 (1.02-2.36)] were more frequently found than in the control group. SMM was not identified as independently associated with any of the main outcomes. CONCLUSION: SMM showed to be associated with a negative impact on growth and neurodevelopment aspects of perinatal and infant health. These findings suggest that effective health policies directed towards appropriate care of pregnancy may have an impact on the reduction of maternal, neonatal and infant morbidity and mortality.

Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

BACKGROUND: In clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial. METHODS: The women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using thematic analysis. After the analysis categories were defined, all the answers were reviewed, categorized and grouped. A descriptive summary of the content of each category was then made. RESULTS: Overall, 208 women from different geographical regions of the country agreed to participate. Four categories were identified: 1) The risk of losing the baby; 2) A previous experience of premature delivery; 3) The role of the doctor and other health professionals, and 4) The availability of quality medical care and free medication. The main reason given for agreeing to participate was to reduce the risks associated with the baby being born prematurely, particularly when the woman herself or someone close to her had already experienced premature delivery. Other reasons were having received clear guidance and explanations from the doctor regarding prematurity and about the study and being given the opportunity to receive free treatment with greater access to the public healthcare system. CONCLUSIONS: The decision to participate in a clinical trial is not easy, particularly when the individual is vulnerable and in a critical situation as in the case of a pregnant woman at a high risk of delivering prematurely. Fears and uncertainties regarding the pregnancy outcome, as well as the woman's previous experiences and her awareness of the actual risks she faces will affect her decision regarding whether or not to participate. Recruitment challenges could be overcome by ensuring that the research team provides adequate information and support, thus creating a bond with participants that would foster a sense of safety and trust in the study proposals.

A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial).

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.

"Babies born early?" - silences about prematurity and their consequences.

BACKGROUND: The principal aim of this study was to understand how communication between parents and health professionals concerning prematurity occurs, from delivery to admission to the neonatal Intensive Care Unit. METHODS: This is an exploratory, descriptive study with a qualitative methodology. Data were collected using tape-recorded and Focal Groups technique interview with mothers of premature newborns and health professionals involved in caring for preterm infants, at southeast Brazil. RESULTS: The word "premature" was not said or heard during prenatal care. From the narratives, it was observed that there was a lack of information available to pregnant women about preterm birth, failure in medical care regarding signs and symptoms reported by pregnant women, and lack of communication between the medical teams, mothers and family during delivery and Neonatal Intensive Care Unit (NICU) admission. CONCLUSION: There is a fine line between born too soon and die too soon, that increases stress, fear and distance impacting negatively over communication between mothers and health professionals during antenatal care, childbirth and NICU admission.

Use of metabolomics for the identification and validation of clinical biomarkers for preterm birth: Preterm SAMBA.

BACKGROUND: Spontaneous preterm birth is a complex syndrome with multiple pathways interactions determining its occurrence, including genetic, immunological, physiologic, biochemical and environmental factors. Despite great worldwide efforts in preterm birth prevention, there are no recent effective therapeutic strategies able to decrease spontaneous preterm birth rates or their consequent neonatal morbidity/mortality. The Preterm SAMBA study will associate metabolomics technologies to identify clinical and metabolite predictors for preterm birth. These innovative and unbiased techniques might be a strategic key to advance spontaneous preterm birth prediction. METHODS/DESIGN: Preterm SAMBA study consists of a discovery phase to identify biophysical and untargeted metabolomics from blood and hair samples associated with preterm birth, plus a validation phase to evaluate the performance of the predictive modelling. The first phase, a case-control study, will randomly select 100 women who had a spontaneous preterm birth (before 37 weeks) and 100 women who had term birth in the Cork Ireland and Auckland New Zealand cohorts within the SCOPE study, an international consortium aimed to identify potential metabolomic predictors using biophysical data and blood samples collected at 20 weeks of gestation. The validation phase will recruit 1150 Brazilian pregnant women from five participant centres and will collect blood and hair samples at 20 weeks of gestation to evaluate the performance of the algorithm model (sensitivity, specificity, predictive values and likelihood ratios) in predicting spontaneous preterm birth (before 34 weeks, with a secondary analysis of delivery before 37 weeks). DISCUSSION: The Preterm SAMBA study intends to step forward on preterm birth prediction using metabolomics techniques, and accurate protocols for sample collection among multi-ethnic populations. The use of metabolomics in medical science research is innovative and promises to provide solutions for disorders with multiple complex underlying determinants such as spontaneous preterm birth.

Sexual life and dysfunction after maternal morbidity: a systematic review.

BACKGROUND: Because there is a lack of knowledge on the long-term consequences of maternal morbidity/near miss episodes on women's sexual life and function we conducted a systematic review with the purpose of identifying the available evidence on any sexual impairment associated with complications from pregnancy and childbirth. METHODS: Systematic review on aspects of women sexual life after any maternal morbidity and/or maternal near miss, during different time periods after delivery. The search was carried out until May 22(nd), 2015 including studies published from 1995 to 2015. No language or study design restrictions were applied. Maternal morbidity as exposure was split into general or severe/near miss. Female sexual outcomes evaluated were dyspareunia, Female Sexual Function Index (FSFI) scores and time to resume sexual activity after childbirth. Qualitative syntheses for outcomes were provided whenever possible. RESULTS: A total of 2,573 studies were initially identified, and 14 were included for analysis after standard selection procedures for systematic review. General morbidity was mainly related to major perineal injury (3(rd) or 4(th) degree laceration, 12 studies). A clear pattern for severity evaluation of maternal morbidity could not be distinguished, unless when a maternal near miss concept was used. Women experiencing maternal morbidity had more frequently dyspareunia and resumed sexual activity later, when compared to women without morbidity. There were no differences in FSFI scores between groups. Meta-analysis could not be performed, since included studies were too heterogeneous regarding study design, evaluation of exposure and/or outcome and time span. CONCLUSION: Investigation of long-term repercussions on women's sexual life aspects after maternal morbidity has been scarcely performed, however indicating worse outcomes for those experiencing morbidity. Further standardized evaluation of these conditions among maternal morbidity survivors may provide relevant information for clinical follow-up and reproductive planning for women.

Maternal near miss among women using the public health system in the Amazon and Northeast regions of Brazil.

OBJECTIVE: To assess the prevalence of pregnancy complications identified as maternal near miss (MNM) and associated factors among women using the public health care system in the Amazon and Northeast regions of Brazil. METHODS: A secondary analysis of a population-based survey conducted in 2010 was performed focusing on women self-reporting maternal complications. The main outcome was MNM, pragmatically defined as intensive care unit admission, eclampsia, hysterectomy, or blood transfusion. In addition, the risk of MNM was estimated for certain sociodemographics and characteristics of care received. Poisson regression was performed, generating adjusted prevalence ratios (PRadj) with 95% confidence intervals (95%CI). RESULTS: A total of 13 044 women (77%) who had given birth during the prior year using the public health system were interviewed. At least one complication was reported by 37.5%, with hemorrhage (28.4%) and infection (8.3%) being the most frequent. The overall MNM ratio was 31.5 per 1 000 live births, higher for the Amazon region than for the Northeast. Factors with a higher risk for developing MNM were: indigenous ethnicity (PRadj 2.77; 95% CI: 1.50-5.14), more than one hour to reach the hospital (PRadj 1.55; 95%CI: 1.06-2.25), being refused by a full hospital and having to find another one (PRadj 1.49; 95%CI: 1.03-2.16), cesarean section (PRadj 2.56; 95%CI: 1.90-3.44), and public prenatal care (PRadj 1.95; 95%CI: 1.06-3.61). CONCLUSIONS: Users of public health system in the Amazon and Northeast regions of Brazil have high MNM rates. Some characteristics of the women and of the care they received represent inequalities associated with higher risk for MNM. Specific actions are required to improve maternal health programs in these expansive areas of the country.

Delays in receiving obstetric care and poor maternal outcomes: results from a national multicentre cross-sectional study.

BACKGROUND: The vast majority of maternal deaths in low-and middle-income countries are preventable. Delay in obtaining access to appropriate health care is a fairly common problem which can be improved. The objective of this study was to explore the association between delay in providing obstetric health care and severe maternal morbidity/death. METHODS: This was a multicentre cross-sectional study, involving 27 referral obstetric facilities in all Brazilian regions between 2009 and 2010. All women admitted to the hospital with a pregnancy-related cause were screened, searching for potentially life-threatening conditions (PLTC), maternal death (MD) and maternal near-miss (MNM) cases, according to the WHO criteria. Data on delays were collected by medical chart review and interview with the medical staff. The prevalence of the three different types of delays was estimated according to the level of care and outcome of the complication. For factors associated with any delay, the PR and 95%CI controlled for cluster design were estimated. RESULTS: A total of 82,144 live births were screened, with 9,555 PLTC, MNM or MD cases prospectively identified. Overall, any type of delay was observed in 53.8% of cases; delay related to user factors was observed in 10.2%, 34.6% of delays were related to health service accessibility and 25.7% were related to quality of medical care. The occurrence of any delay was associated with increasing severity of maternal outcome: 52% in PLTC, 68.4% in MNM and 84.1% in MD. CONCLUSIONS: Although this was not a population-based study and the results could not be generalized, there was a very clear and significant association between frequency of delay and severity of outcome, suggesting that timely and proper management are related to survival.

Surviving maternal sepsis: Clinical, laboratory, and treatment features.

OBJECTIVE: To describe clinical, laboratory, and antibiotic treatment characteristics in pregnant or recently pregnant women diagnosed with maternal sepsis. METHODS: A retrospective cohort study was conducted in a Brazilian tertiary hospital from March 2014 until February 2018. The hospital implemented a Sepsis Protocol, based on the Brazilian Ministry of Health recommendation. All women who were pregnant or recently pregnant (up to 42 days postpartum), and who presented with suspected sepsis were included. Unconfirmed infections were excluded. Three hundred sixty-five women were included and divided into three groups according to sepsis severity (SEPSIS-2): sepsis, severe sepsis, and septic shock. Clinical, laboratory, and management characteristics were described and compared. RESULTS: Pregnancy-related and respiratory tract infections were the greater causes of maternal sepsis, and the urinary tract was the major cause of septic shock. We found almost total compliance with blood culture sample collection, and samples were positive in 10.8% of the cases, and in 41% of septic shock patients. Escherichia coli was the most common pathogen found and it was resistant to third-generation cephalosporins in none of the blood cultures and 3.3% of the urine cultures. Using the AWaRe (Access, Watch and Reserve) classification groups of antibiotics, Access and Watch antibiotics were used in virtually all women. We did not find any fatal maternal outcomes. CONCLUSION: Maternal sepsis is seldom the result of resistant microorganisms in this setting and the use of Access group antibiotics is widely possible. Health professionals' awareness of and institutional policies for maternal sepsis are crucial to its adequate treatment and better outcomes.

Risk factors related to the SARS-CoV-2 vaccine additional doses hesitancy among pregnant and non-pregnant people of reproductive age and partners: A Brazilian cross-sectional study.

OBJECTIVE: The aim of this study was to assess the predictors of acceptance and hesitancy of additional doses of any SARS-CoV-2 (COVID-19) vaccine among pregnant or recently pregnant and non-pregnant people of reproductive age and partners in Brazil. METHODS: We conducted an online cross-sectional study from June 2022 to April 2023 and invited women and partners between 18 and 49 years old to participate. We employed a snowball strategy to reach all potential eligible participants. Our primary outcome was the acceptance rate of the COVID-19 booster vaccine. We estimated the frequency and percentage for the three groups and compared categorical variables using the Chi-square test. Moreover, bivariate, backward stepwise regression, and subgroup analyses were performed to evaluate risk factors and predictors of COVID-19 vaccine booster hesitancy. We reported the effect size as OR with a 95% CI. RESULTS: We included 1487 participants, and among them, 334 (22.5%) were pregnant or recently pregnant people, 905 (60.8%) were non-pregnant people, and 247 (16.6%) were male partners. Pregnant and recently pregnant people showed greater hesitancy for the COVID-19 vaccine booster than non-pregnant people (28% vs 15%, P < 0.001) and male partners (28% vs 16%, P < 0.001). Non-pregnant women accepted the COVID-19 vaccine more often than pregnant or recently pregnant people (OR 1.75; 95% CI: 1.13-2.70). The associated factors to the reduced COVID-19 vaccine booster acceptance were family income between US$ 566-945.00 (54%), evangelic religion (65%), concern about vaccine safety (80%) and perceived common vaccine importance (93%). CONCLUSION: Pregnant people were more hesitant than non-pregnant people to accept the COVID-19 booster vaccine. Family income, religious beliefs, vaccine safety concerns, and perceived common vaccine importance were significant barriers to accepting COVID-19 booster vaccines. The impact of these factors was more evident among pregnant or recently pregnant people, emphasizing the harmful effect of misinformation among this vulnerable population.

The effect of body mass index on maternal and perinatal outcomes in COVID-19 infection during pregnancy and postpartum: Secondary analysis from the REBRACO cohort study.

OBJECTIVES: To compare maternal and perinatal outcomes among women with obesity, overweight, and normal body mass index, associated with COVID-19 infection during pregnancy and postpartum. METHOD: Prospective Cohort Study, within the REBRACO (Brazilian Network of COVID-19 in Pregnancy) multicenter initiative. Confirmed positive cases of SARS-CoV-2 were included, and women categorized into three groups according to their pre-pregnancy BMI: obesity (BMI ≥ 30), overweight (BMI <30 but >25), and normal BMI. Sociodemographic, clinical, and obstetric characteristics and different maternal and perinatal outcomes were compared, and a multiple regression analysis was performed to investigate factors independently associated with adverse maternal and perinatal outcomes. RESULTS: Two hundred eighty-nine women positive for SARS-CoV-2 infection were considered, and 202 had available data on maternal BMI for the current analysis. Overall, 72 (35.6%)obese, 68 (33.6%) overweight, and 60 (29.7%) normal BMI. Obesity was associated with increased adverse clinical outcomes including sepsis (P = 0.02), acute respiratory distress syndrome (P = 0.002), and the need for mechanical ventilation (P = 0.044). Considering perinatal outcomes, a multiple regression model confirmed obesity as an independent factor associated with adverse results (adjusted odds ratio 3.73, 95% CI 1.54-9.08). CONCLUSION: Obesity and overweight were associated with worse clinical outcomes, severe/critical COVID-19, and adverse perinatal outcomes.

The experience of pregnant women and their families who were infected with covid-19 before vaccination: A qualitative approach within a multicenter study in Brazil.

BACKGROUND: Pregnant and postpartum women infected by COVID-19 are at increased risk of adverse outcomes, including negative effects on their mental health. Brazilian maternal mortality rate due to COVID-19 is 2.5 times higher than overall mortality rates. This study aimed to understand how pregnant/postpartum women experienced the COVID-19 suspicion/investigation or confirmed infection in different Brazilian cities, the pandemic's consequences to women and their families, and their needs to improve maternal health services during public health emergencies. METHODS: We conducted a qualitative study with 27 women with COVID-19 and 6 of their family members, as part of a multicenter study among 15 maternity hospitals in Brazil. We applied in-depth interviews through telephone calls when women received the diagnostic or had a suspect infection and after 60 days. Another semi-structured interview was applied to their close family members. The interviews were considered through thematic analysis. RESULTS: From the thematic content analysis three major themes emerged from the first and second interviews: (Cucinotta and Vanelli, 2020) assistance received by the woman and newborn in the medical services; (World Health Organization (WHO) 2021) stigma/fear of contamination from health workers and from family and friends reported by the women; (Allotey et al., 2020) the COVID-19 pandemic impact. CONCLUSION: Before the availability of the COVID-19 vaccine, pregnant women experienced fear of death, hospitalization, quarantine, loss of family members, and financial repercussions, resulting in physical, psychological, and socioeconomic impacts on these women's lives.

Estimation of preterm birth rate, associated factors and maternal morbidity from a demographic and health survey in Brazil.

To determine the prevalence of preterm birth from self-reports by Brazilian women, to assess complications, interventions and outcomes, to identify factors associated with preterm birth, and to improve the preterm birth rates estimates. This is a secondary analysis of data from a Demographic Health Survey. It interviewed a sample of 4,743 Brazilian women who had 6,113 live births from 2001 to 2007. Estimates of preterm birth rates were obtained per region and per year according to self-reported gestational age. The prevalence rate and 95 % confidence interval (CI) for preterm was determined according to the characteristics of mothers and offspring. Odds ratios and 95 % CI were estimated for complications such as severe maternal morbidity. The preterm birth rate was 9.9 %, with regional variations. Preterm birth was more likely to be associated with neonatal death, low birth weight, and longer hospital stay. Maternal factors associated with preterm birth were: white ethnicity, living in an urban area, history of hypertension or heart disease, twin gestation, non-elective Cesarean section, medical insurance for delivery, low number of antenatal visits, and severe morbidity. A self-report survey has indicated that the preterm birth rate in Brazil is higher than official data suggest, with an increasing trend in more developed areas, and is associated with poor neonatal and maternal outcomes.

Estimates of avoided costs attributed to a short cervix screening program to prevent preterm birth from the perspective of the Unified Health System (SUS).

OBJECTIVE: To perform an economic cost analysis of the implementation of a short cervix screening program to reduce preterm birth in singleton pregnancies in a short-term time horizon. METHODS: We performed a cost-benefit economic analysis using the P5 trial database, a randomized multicenter clinical trial for prevention of preterm birth. Data collection was conducted from July 2015 to March 2019 in 17 different Brazilian hospitals. We conducted a cost analysis for universal cervical screening in singleton pregnancies between 18 weeks and 22 weeks plus 6 days. In subjects with a cervical length ≤ 25 mm, the analysis incorporated the costs of administering 200 mg/day of vaginal progesterone prophylactically until 36 weeks gestation. These findings were subsequently compared with the economic implications of forgoing cervical screening. The time horizon comprised from birth to 10 weeks postpartum. The outcome was measured monetarily in Brazilian real (R$) from the perspective of the Unified Health System. RESULTS: Among 7,844 women, 6.67% (523) had a cervix ≤ 25 mm. The cost of screening with transvaginal ultrasound and vaginal progesterone for prevention of births with < 34 weeks was estimated at R$ 383,711.36, while non-screening generated an estimated additional cost of R$ 446,501.69 (related to the 29 non-screened preterm deliveries). Thus, screening and prophylaxis would generate a final cost reduction of R$ 62,790.33, constituting a possible cost-benefit strategy. CONCLUSION: Universal short cervix screening for preterm birth has lower costs compared to non-screening within a short-term time horizon, which suggests an interesting benefit-cost ratio. Future studies should consider the cost-effectiveness of prophylactic treatment using sensitivity analyses in different scenarios within the Brazilian health system, as well as analyses that consider the long-term costs associated with preterm births, to robustly justify the implementation of a short cervix screening program.

Maternal diet and interactions with nutritional evaluation during pregnancy.

This narrative review aims to describe the knowledge regarding nutritional evaluation and monitoring in pregnant women. We discuss care provided by non-specialists in nutrition, regarding dietary information and risks during pregnancy, from a theoretical or conceptual viewpoint. A narrative review was conducted following a literature search when scientific databases were investigated, including SciELO, LILACS, Medline, PubMed, theses, government reports, books, and chapters in books. Finally, the material was fully read, categorized, and critically analyzed. National and international protocols of prenatal nutritional care were included and discussed. Different protocols describe the complexity of evaluating and monitoring nutrition among pregnant women during the prenatal period according to each country. The understanding of social conditions and eating habits has an important role in providing nutritional advice during pregnancy. The lack of dietitians in care overwhelms the healthcare workers and characterizes a missed opportunity. Therefore, it is important to consider rapid support tools that can track adverse nutritional status, and ways to recommend a diet that meets eating habit dynamics, according to the reality of each public health system.

A conceptual framework for nutritional evaluation, screening, and monitoring of pregnant women: Evidence from a Brazilian cohort of nulliparous women.

The present review comes from five previous studies of a multicenter cohort of nulliparous pregnant women from different regions of Brazil. The first study showed a wide difference in consumption of industrialized foods among women from the south and southeast regions compared with northeastern women who chose to eat a healthier diet with fresh natural food. The second investigation intended to understand maternal eating habits, where five dietary patterns were identified: two considered healthy and three with excess protein, ultra-processed foods, fats, and sweets. Considering some barriers to classifying nutrition status during prenatal care, when data on pre-pregnancy weight is unknown, the third study developed a tool to identify three levels of risk for each gestational age range, assessed by measuring arm circumference. Applying those new tools, the associations between maternal nutrition and pregnancy outcomes were investigated: prematurity, pre-eclampsia, gestational diabetes mellitus, and small-for-gestational-age infants. From these analyses, a predictive model was developed indicating that obesity, non-white color, and dietary pattern with excess protein consumption were associated with a greater probability of adverse pregnancy outcomes. Moreover, the potential of the intergenerational influence of head circumference as a proxy for maternal nutrition was analyzed. Using a Path Analysis method, the model was evidenced by different socioeconomic variables. Finally, understanding the complexity of the nutritional assessment, the present conceptual framework was proposed for nutritional assessment, and tracking and monitoring of pregnant women.

Pessary Plus Progesterone to Prevent Preterm Birth in Women With Short Cervixes: A Randomized Controlled Trial.

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.