ENG-releasing subdermal implants in postpartum teenagers - an open-label trial study protocol.

BACKGROUND: Higher than expected adolescent pregnancy high rates continue globally, with repeated unplanned pregnancy (UP) in this age group is a public health problem. In Brazil, 16% of pregnancies occur in adolescents under 18 years old, with high maternal morbidity and mortality rates in this age group. Effective and safe contraception is required to reduce UP rates. The objective of our study is to evaluate acceptance of etonogestrel (ENG)-releasing subdermal contraceptive implant after childbirth, before discharge, as well as clinical performance up to one year after placement. Comparison between teenagers who opt for ENG-implant versus other contraceptive methods after childbirth will be also evaluated, specifically regarding UP, continuation and discontinuation rates and reasons, body composition, pelvic ultrasound characteristics and user satisfaction. METHODS: A non-randomized open-label trial will be conducted with teenagers after childbirth and followed up to one year at the Women's Hospital, University of Campinas (UNICAMP), Campinas, Brazil. The study group will consist of patients who accepted to use ENG-implant and placed before discharge. The comparison group will include adolescents who choose to use other contraceptive methods at the first postpartum visit (42 ± 3 days after childbirth). All women will follow-up at 40-60 days postpartum, as well as, at 6 and 12 months post-enrollment. Patient satisfaction, contraceptive effectiveness, reasons of discontinuation, continuation rate and body composition will be evaluated. Transvaginal ultrasound and electric bio impedance tests will be performed at all follow-up appointments. A 5% significance level was assumed, as well as, a sampling error (absolute) for 10% prevalence. The sample size was calculated at n = 100, obtaining an estimate of 50 to 70 adolescents who would accept the method offered, according to the prevalence and sample error assumed. DISCUSSION: Long-acting reversible contraceptive (LARC) methods include subdermal implants and intrauterine contraceptives, are considered first line contraception for teenagers. Immediate postpartum use is a safe option, which significantly reduces rates of repeated UP and all the undesirable consequences inherent to this process. TRIAL REGISTRATION: This study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 92869018.5.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC): http://www.ensaiosclinicos.gov.br/rg/RBR-4z7bc6, (number 2.901.752).

Systemic lupus erythematosus and pregnancy: the challenge of improving antenatal care and outcomes.

OBJECTIVES: The objective of this article is to describe maternal and perinatal outcomes in women with systemic lupus erythematosus (SLE) followed in a high-risk prenatal outpatient clinic at a referral center. METHODS: This observational study included pregnant women with SLE who underwent prenatal follow-up and childbirth at the Women's Hospital, University of Campinas, from January 2012 to January 2018. All women were followed according to the institution's protocol for pregnant women with SLE. They were subdivided into two groups according to the presence of disease activity during the preconception and gestation periods, and evaluated according to the Systemic Lupus Erythematosus Disease Activity Index and Systemic Lupus Erythematosus Pregnancy Disease Activity Index scales. Data were retrieved from patients' medical records. Chi-square, Fisher exact and Mann-Whitney tests and multivariable analyses were performed. Statistical significance level was 5% (p < .05). RESULTS: A total of 125 cases were initially included; those who were lost to follow-up or gave birth at another hospital were further excluded, with 102 pregnancies (of 95 women) remaining. The mean age of the women was 27.7 years (SD 5.44), and 48% were in their first gestation. The average duration of disease was 6.79 years (SD 5.38), with 92.1% receiving SLE-specific therapy. SLE flare occurred in 8.9% during the preconception period and 23.5% during gestation. Preterm premature rupture of membranes (16.6%), preeclampsia or eclampsia (15.6%) and preterm labor (12.7%) were the most frequent complications. The mean gestational age at birth was 34.4 weeks (SD 5.9); the preterm birth rate was 46.8%, the low birth weight rate was 35.1%, and intensive neonatal care admission was 40.4%. Four fetal deaths and one maternal death occurred, all of them in the group with SLE flares. Multivariable logistic regression analysis showed that preconception lupus activity had a six-fold increased rate of gestational loss (odds ratio (OR): 6.14 (95% confidence interval (CI) 1.26-29.99)), and lupus activity during pregnancy had a five-fold increased rate of prematurity at less than 34 weeks (OR: 5.02 (95% CI: 1.90-13.30)). CONCLUSIONS: Despite the low percentages of women with pregestational and pregnancy-active disease, we found high incidences of maternal and perinatal complications. Preconception SLE activity increased gestational loss, and SLE activity during pregnancy increased prematurity. Effective immunosuppressive therapy was able to decrease clinical and laboratory activity of SLE; however, unfavorable perinatal outcomes still occurred, even when lupus activity was under control. Pregnancy in women with SLE is always a challenge.

Fetal Hemodynamic Parameters in Low Risk Pregnancies: Doppler Velocimetry of Uterine, Umbilical, and Middle Cerebral Artery.

Objective. To elaborate curves of longitudinal reference intervals of pulsatility index (PI) and systolic velocity (SV) for uterine (UtA), umbilical (UA), and middle cerebral arteries (MCA), in low risk pregnancies. Methods. Doppler velocimetric measurements of PI and SV from 63 low risk pregnant women between 16 and 41 weeks of gestational age. Means (±SD) for intervals of gestational age and percentiles 5, 50, and 95 were calculated for each parameter. The Intraclass Correlation Coefficients (ICC) were also estimated for assessing intra- and intervariability of measurements. Results. Mean PI of UtA showed decreasing values during pregnancy, but no regular pattern was identified for mean SV. For UA, PI decreased and SV increased along gestation. MCA presented PI increasing values until 32-35 weeks. SV showed higher levels with increasing gestation. High ICC values indicated good reproducibility. Conclusions. Reference intervals for the assessment of SV and PI of UtA, UA, and MCA were established. These reference intervals showed how a normal pregnancy is expected to progress regarding these Doppler velocimetric parameters and are useful to follow high risk pregnancies. The comparison between results using different curves may provide insights about the best patterns to be used.

Severe maternal morbidity due to respiratory disease and impact of 2009 H1N1 influenza A pandemic in Brazil: results from a national multicenter cross-sectional study.

BACKGROUND: The aim of this study was to assess the burden of respiratory disease, considering the influenza A pandemic season (H1N1pdm09), within the Brazilian Network for Surveillance of Severe Maternal Morbidity, and factors associated with worse maternal outcome. METHODS: A multicenter cross-sectional study, involving 27 referral maternity hospitals in five Brazilian regions. Cases were identified in a prospective surveillance by using the WHO standardized criteria for potentially life-threatening conditions (PLTC) and maternal near miss (MNM). Women with severe complications from respiratory disease identified as suspected or confirmed cases of H1N1 influenza or respiratory failure were compared to those with other causes of severe morbidity. A review of suspected H1N1 influenza cases classified women as non-tested, tested positive and tested negative, comparing their outcomes. Factors associated with severe maternal outcome (SMO = MNM + MD) were assessed in both groups, in comparison to PLTC, using PR and 95 % CI adjusted for design effect of cluster sampling. RESULTS: Among 9555 cases of severe maternal morbidity, 485 (5 %) had respiratory disease. Respiratory disease occurred in one-quarter of MNM cases and two-thirds of MD. H1N1 virus was suspected in 206 cases with respiratory illness. Around 60 % of these women were tested, yielding 49 confirmed cases. Confirmed H1N1 influenza cases had worse adverse outcomes (MNM:MD ratio < 1 (0.9:1), compared to 12:1 in cases due to other causes), and a mortality index > 50 %, in comparison to 7.4 % in other causes of severe maternal morbidity. Delay in medical care was associated with SMO in all cases considered, with a two-fold increased risk among respiratory disease patients. Perinatal outcome was worse in cases complicated by respiratory disease, with increased prematurity, stillbirth, low birth weight and Apgar score < 7. CONCLUSIONS: Respiratory disease, especially considering the influenza season, is a very severe cause of maternal near miss and death. Increased awareness about this condition, preventive vaccination during pregnancy, early diagnosis and treatment are required to improve maternal health.

The role of infection and sepsis in the Brazilian Network for Surveillance of Severe Maternal Morbidity.

OBJECTIVE: To identify the burden of severe infection within the Brazilian Network for Surveillance of Severe Maternal Morbidity and factors associated with worse maternal outcomes. METHODS: This was a multicentre cross-sectional study involving 27 referral maternity hospitals in Brazil. WHO's standardised criteria for potentially life-threatening conditions and maternal near miss were used to identify cases through prospective surveillance and the main cause of morbidity was identified as infection or other causes (hypertension, haemorrhage or clinical/surgical). Complications due to infection were compared to complications due to the remaining causes of morbidity. Factors associated with a severe maternal outcome were assessed for the cases of infection. RESULTS: A total of 502 (5.3%) cases of maternal morbidity were associated with severe infection vs. 9053 cases (94.7%) with other causes. Considering increased severity of cases, infection was responsible for one-fourth of all maternal near miss (23.6%) and nearly half (46.4%) of maternal deaths, with a maternal near miss to maternal death ratio three times (2.8:1) that of cases without infection (7.8:1) and a high mortality index (26.3%). Within cases of infection, substandard care was present in over one half of the severe maternal outcome cases. Factors independently associated with worse maternal outcomes were HIV/AIDS, hysterectomy, prolonged hospitalisation, intensive care admission and delays in medical care. CONCLUSIONS: Infection is an alarming cause of maternal morbidity and mortality and timely diagnosis and adequate management are key to improving outcomes during pregnancy. Delays should be addressed, risk factors identified, and specific protocols of surveillance and care developed for use during pregnancy.

Network for Surveillance of Severe Maternal Morbidity: a powerful national collaboration generating data on maternal health outcomes and care.

OBJECTIVE: To identify cases of severe maternal morbidity (SMM) during pregnancy and childbirth, their characteristics, and to test the feasibility of scaling up World Health Organization criteria for identifying women at risk of a worse outcome. DESIGN: Multicentre cross-sectional study. SETTING: Twenty-seven referral maternity hospitals from all regions of Brazil. POPULATION: Cases of SMM identified among 82 388 delivering women over a 1-year period. METHODS: Prospective surveillance using the World Health Organization's criteria for potentially life-threatening conditions (PLTC) and maternal near-miss (MNM) identified and assessed cases with severe morbidity or death. MAIN OUTCOME MEASURES: Indicators of maternal morbidity and mortality; sociodemographic, clinical and obstetric characteristics; gestational and perinatal outcomes; main causes of morbidity and delays in care. RESULTS: Among 9555 cases of SMM, there were 140 deaths and 770 cases of MNM. The main determining cause of maternal complication was hypertensive disease. Criteria for MNM conditions were more frequent as the severity of the outcome increased, all combined in over 75% of maternal deaths. CONCLUSIONS: This study identified around 9.5% of MNM or death among all cases developing any severe maternal complication. Multicentre studies on surveillance of SMM, with organised collaboration and adequate study protocols can be successfully implemented, even in low-income and middle-income settings, generating important information on maternal health and care to be used to implement appropriate health policies and interventions. TWEETABLE ABSTRACT: Surveillance of severe maternal morbidity was proved to be possible in a hospital network in Brazil.

The effect of physical exercise strategies on weight loss in postpartum women: a systematic review and meta-analysis.

For women of reproductive age, excessive gestational weight gain and/or postpartum weight retention can increase the risk of obesity. This systematic review evaluates the effectiveness of lifestyle modification control trials that utilize exercise interventions, with or without dietary intervention, on weight loss among postpartum women. A search of randomized clinical trials (RCT) was performed using the follow databases and the bibliography of candidate studies: MEDLINE, Web of Science, EMBASE, CENTRAL/Cochrane and Physiotherapy Evidence Database. English language RCT papers published up to 31 October 2012, which present changes on maternal body weight from baseline to the end of exercise intervention were included. The primary meta-analysis examined the effects of exercise interventions, with or without complementary dietary intervention, on weight loss during the postpartum period compared with usual standard of care. Five subgroup analyses were performed to examine differences in study interventions and exercise modalities: duration of intervention, quality of study methodology, supervision of exercise intervention, exercise intervention goals used and the type of dietary intervention. In total 11 studies met eligibility criteria with 769 participants, 409 under intervention and 360 in the control group. The primary meta-analysis included all 11 studies and found a mean difference (MD) on weight loss of -2.57 kg (95% CI -3.66 to -1.47). The subgroup analysis demonstrated that the most effective interventions in reducing weight in postpartum women were exercise programs with objectively defined goals, such as the use of heart rate monitors or pedometer (MD of -4.09 kg-95% CI -4.94 to -3.25, I(2)=0%) and exercise combined with intensive dietary intervention (MD of -4.34 kg-95% CI -5.15 to -3.52, I(2)=0%). Thus, there is benefit from overall lifestyle interventions on weight loss in postpartum women and exercise plus intensive diet and objective targets are the most effective intervention strategies.

Sonographic measurement of the umbilical cord area and the diameters of its vessels during pregnancy.

The objective was to determine the cross-sectional area of the umbilical cord, its diameter and the diameter of its vessels to establish a reference curve for these parameters during pregnancy, through a prospective cross-sectional study, including 2,310 low-risk pregnancies between 12 and 40 weeks' gestation. Means and standard deviations (SDs), plus the 10th, 50th and 90th percentiles for each measurement were calculated using polynomial regression analysis. Mann-Whitney, Kruskal-Wallis and Wilcoxon tests were used for statistical analysis. These parameters increased significantly with gestational age. The area of the cord also varied significantly with parity. Their new reference curves for low risk pregnancies were calculated using polynomial regression, and an almost linear increase in values was found up to 32 weeks of pregnancy, tending to stabilise from then onwards. The regression equation of the umbilical cord area according to gestational age (GA) was: -1.417 + 0.3026*GA-0.008*GA(2) + 0.000007*GA(3) and the degree of adjustment (R(2)) was 0.89.

The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial.

OBJECTIVE: To evaluate the effectiveness and safety of physical exercise in terms of maternal/perinatal outcomes and the perception of quality of life (QoL) in pregnant obese and overweight women. DESIGN: A randomised controlled clinical trial. SETTING: The Prenatal Outpatient Clinic of the Women's Integral Healthcare Centre (CAISM-UNICAMP) at the University of Campinas, Campinas, Brazil. POPULATION: Eighty-two pregnant women (age ≥ 18 years; pre-gestational body mass index ≥ 26 kg/m(2) ; gestational age 14-24 weeks). METHODS: Women were randomised into two groups: women in one group exercised under supervision and received home exercise counselling (the 'study group'; n = 40) and women in the other group followed the routine prenatal care programme (the 'control group'; n = 42). MAIN OUTCOME MEASURES: Primary outcomes were gestational weight gain during the programme and excessive maternal weight gain. Secondary outcomes were increased arterial blood pressure, perinatal outcomes and QoL (WHOQOL-BREF). RESULTS: In the study group, 47% of pregnant women had weight gains above the recommended limit, compared with 57% of women in the control group (P = 0.43). There was no difference in gestational weight gain between the groups. Overweight pregnant women who exercised gained less weight during the entire pregnancy (10.0 ± 1.7 kg versus 16.4 ± 3.9 kg, respectively; P = 0.001) and after entry into the study (5.9 ± 4.3 kg versus 11.9 ± 1.5 kg, respectively; P = 0.021) compared with women in the control group. Arterial blood pressure was similar between the groups over time. There was no difference in perinatal outcome or QoL. CONCLUSIONS: The exercise programme was not associated with control of gestational weight gain in our sample as a whole, but was beneficial for lower gestational weight gain in overweight women. Exercise was not associated with adverse perinatal outcomes and did not affect variation in arterial blood pressure or the perception of QoL.

Pregnancy outcome in female liver transplant recipients.

UNLABELLED: Transplantation has become an available and successful treatment option for numerous congenital and acquired hepatic disorders. Studies have shown that when the prepregnancy recipient graft function is stable and adequate, pregnancy is normally well tolerated with favorable neonatal outcomes. However, there are reports of increased incidences of hypertension and preeclampsia as well as lower birth weights and prematurity. Patients administered tacrolimus-based therapies seem to have lower incidences of these complications. CASE REPORTS: The 5 reported patients, aged 23­37 years at the time of conception, were 2­11 years posttransplantation. A preterm delivery for fetal distress was the most clinically important complication among these patients. One episode of acute genital herpes infection, 1 liver hematoma in a patient who was anticoagulated owing to a history of deep vein thrombosis, and 1 case of wound infection postpartum were also observed. Despite these complications, all 5 pregnancies were successful. The mean gestational age at delivery was 35.2 weeks. No structural malformations or early complications were observed in the neonates. All cases showed stable liver parameters.

Predictors of preterm birth.

OBJECTIVE: This is a systematic review to assess published scientific evidence on preterm birth predictors. METHODS: An Internet search for predictors of preterm birth was performed and the evidence level of each method was evaluated. RESULTS: There is strong evidence that preterm birth can be predicted using vaginal sonography to evaluate cervical characteristics, fetal fibronectin in cervicovaginal secretions and interleukin-6 in amniotic fluid. There is consistent evidence that digital cervical examination is a weak predictor, and controversy regarding home uterine activity monitoring. There is scanty evidence about the predictive ability of maternal history and perceptions of symptoms since the study design fails to provide high evidence level. CONCLUSION: Cervical evaluation by vaginal sonography, fetal fibronectin and interleukin-6 are the best methods for predicting preterm birth.

Hyaluronidase versus Foley catheter for cervical ripening in high-risk term and post term pregnancies.

OBJECTIVE: To evaluate the effectiveness and safety of Foley catheter and hyaluronidase for cervical ripening. METHOD: Randomized controlled trial where 140 pregnant women, with gestational age > or = 37 weeks, indication for labor induction and an unripe cervix, were enrolled, allocated in two groups according to the method of cervical ripening before labor induction. Statistical analysis used Student's t-test, Mann-Whitney, Chi-square test, survival analysis, risk ratios and number needed to treat. RESULTS: Time of induction, dose of oxytocin and mode of delivery had better results in the Foley catheter group. Comfort with the method was higher in the hyaluronidase group. CONCLUSIONS: Both methods were effective and safe for cervical ripening. The Foley catheter group experienced a shorter period of induction, required a lower dose of oxytocin and had higher vaginal delivery rates, while the women who used hyaluronidase declared greater comfort with the method.

Calcified abdominal pregnancy with eighteen years of evolution: case report.

CONTEXT: The lithopedion (calcified abdominal pregnancy) is a rare phenomenon and there are less than 300 cases reported in the medical literature. CASE REPORT: In this case, a 40 year-old patient had had her only pregnancy 18 years earlier, without medical assistance since then. She came to our hospital with pain and tumoral mass of approximately 20 centimeters in diameter. Complementary examinations (abdominal X-ray, ultrasonography and computerized tomography) demonstrated an extra-uterine abdominal 31-week pregnancy with calcification areas. Exploratory laparotomy was performed, with extirpation of a well-conserved fetus with partially calcified ovular membranes.

Maternal mortality in Campinas: evolution, under-registration and avoidance.

CONTEXT: Up until a few years ago, maternal mortality did not merit much attention as a worldwide public health issue. The health and social development indicator almost exclusively used was infant death. OBJECTIVE: To study the number, characteristics, basic causes and avoidance of maternal mortality (MM) among women living in the city of Campinas, which occurred between 1985 and 1991, identified from all death certificates of women aged 10 through 49 years. DESIGN: Retrospective and descriptive population-based study. SETTING: University Referal Center. SAMPLES: All eligible death certificates classified as declared and presumed maternal deaths according to the Laurenti criteria for the cause of death were selected and complementary studies of the clinical records were performed. MAIN MEASURES: Day of the week and place of occurrence of death; period of occurrence; transfer from another hospital; number of days from delivery/abortion to death; blood transfusion; opportunity for transfusion; complications; autopsy; basic cause of death. RESULTS: Initially 39 declared maternal deaths were identified and a total of 62 were confirmed by the end of the study. This corresponds to an under-registration rate of 37.1% and to an MM ratio of 45.5 per 100,000 live births. Around three-fourths of these maternal deaths were due to a direct obstetrical cause and were considered avoidable. CONCLUSION: Maternal mortality still is high in the municipality of Campinas, although lower than the mean estimated for Brazil. The predominance of direct obstetric causes and avoidable deaths reinforces the need for public health interventions directed towards avoiding them.