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Background To investigate the associations of maternal variables – sociodemographic, obstetrical and maternal near miss (MNM) variables – with neonatal near miss (NNM) using the new concept of NNM formulated by the Centro Latino-Americano de Perinatologia (CLAP) and the corresponding health indicators for NNM. Methods An analytical prospective cohort study was performed at maternity hospital for high-risk pregnancy in Northeastern Brazil. Puerperal women whose newborn infants met the selection criteria were subjected to interviews involving pretested questionnaires. Statistical analysis was performed with the Epi Info 3.5.1 program using the Chi square test and Fisher’s exact test when appropriate, with a level of significance of 5%. A bivariate analysis was performed to evaluate differences between the groups. All the variables evaluated in the bivariate analysis were subsequently included in the multivariate analysis. For stepwise logistic regression analysis, a hierarchical model was plotted to assess variable responses and adverse outcomes associated with MNM and NNM variables. Result s There were 1002 live births (LB) from June 2015 through May 2016, corresponding to 723 newborn infants (72.2%) without any neonatal adverse outcomes, 221 (22%) NNM cases, 44 (4.4%) early neonatal deaths and 14 (1.4%) late neonatal deaths. The incidence of NNM was 220/1000 LB. Following multivariate analysis, the factors that remained significantly associated with increased risk of NNM were fewer than 6 prenatal care visits (odds ratio (OR): 3.57; 95% confidence interval (CI): 2.57–4.94) and fetal malformations (OR: 8.78; 95% CI: 3.69–20.90). Maternal age older than 35 years (OR: 0.43; 95% CI: 0.23–0.83) and previous cesarean section (OR: 0.45; 95% CI: 0.29–0.68) protected against NNM. Conclusion Based on the large differences between the NNM and neonatal mortality rates found in the present study and the fact that NNM seems to be a preventable precursor of neonatal death, we suggest that all cases of NNM should be audited. Inadequate prenatal care and fetal malformations increased the risk of NNM, while older maternal age and a history of a previous cesarean section were protective factors.

Background Preeclampsia is implicated in 14% of maternal deaths worldwide, mostly due to complications such as intracranial hemorrhage and cerebral edema. Cerebral edema increases intracranial pressure, which can be predicted by ultrasonographic measurement of the optic nerve sheath diameter (ONSD). Greater diameters have been reported in women with preeclampsia and eclampsia; however, data are lacking on the possible association with maternal and neonatal adverse outcomes. This study aimed to determine whether there is an association between hypertensive disorders of pregnancy and the ONSD, and between this measurement and maternal and neonatal adverse outcomes. Methods This was a cohort study involving 183 women in the third trimester of pregnancy or within 24 h following childbirth, distributed as follows: control group ( n  = 30), gestational hypertension ( n  = 14), chronic hypertension ( n  = 12), preeclampsia without severe features ( n  = 12), preeclampsia with severe features ( n  = 62), superimposed preeclampsia ( n  = 23) and eclampsia ( n  = 30). The participants underwent ocular ultrasonography, and data on maternal and neonatal outcomes were collected from the medical records. To compare the groups, analysis of variance was used for the normally distributed numerical variables and the Kruskal–Wallis test was used for variables with non-normal distribution. Two-tailed p-values ≤ 0.05 were considered statistically significant. Results Overall comparison between the seven groups showed no statistically significant difference in the mean ONSD ( p  = 0.056). Nevertheless, diameters were significantly greater in the eclampsia group compared to the control group ( p  = 0.003). Greater diameters were associated with maternal admission to the intensive care unit (ICU) ( p  < 0.01) and maternal near miss ( p  = 0.01). There was no association between ONSD and admission to the neonatal ICU ( p  = 0.1), neonatal near miss ( p  = 0.34) or neonatal death ( p  = 0.26). Conclusions No association was found between ONSD and the hypertensive disorders of pregnancy in the overall analysis; however, ONSD was greater in women with eclampsia compared to controls. Greater diameters were associated with maternal admission to the ICU and maternal near miss. These findings suggest a potential use for bedside ultrasound as an additional tool for stratifying risk in patients with hypertensive disorders of pregnancy.

Background To investigate the association between sociodemographic and obstetric variables and delays in care with maternal near misses (MNMs) and their health indicators. Methods A prospective cohort study was conducted at a high-risk maternity hospital in northeastern Brazil from June 2015 to May 2016 that included all pregnant women seen at the maternity hospital during the data collection period and excluded those who had not been discharged at the end of the study or whom we were unable to contact after the 42nd postpartum day for MNM control. We used the MNM criteria recommended by the WHO. Risk ratios (RRs) and their 95% confidence intervals (CIs) were calculated. Hierarchical multiple logistic regression analysis was performed. The p values of all tests were two-tailed, and the significance level was set to 5%. Results A total of 1094 pregnant women were studied. We identified 682 (62.4%) women without adverse maternal outcomes (WOAMOs) and 412 (37.6%) with adverse maternal outcomes (WAMOs), of whom 352 had potentially life-threatening conditions (PLTCs) (85.4%), including 55 MNM cases (13.3%) and five maternal deaths (1.2%). During the study period, 1002 live births (LBs) were recorded at the maternity hospital, resulting in an MNM ratio of 54.8/1000 LB. The MNM distribution by clinical condition identified hypertension in pregnancy (67.2%), hemorrhage (42.2%) and sepsis (12.7%). In the multivariate analysis, the factors significantly associated with an increased risk of MNM were fewer than six prenatal visits (OR: 3.13; 95% CI: 1.74–5.64) and cesarean section in the current pregnancy (OR: 2.91; 95% CI: 1.45–5.82). Conclusions The factors significantly associated with the occurrence of MNM were fewer than six prenatal visits and cesarean section in the current pregnancy. These findings highlight the need for improved quality, an increased number of prenatal visits and the identification of innovative and viable models of labor and delivery care that value normal delivery and decrease the percentage of unnecessary cesarean sections.

Background Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, particularly in low- and middle-income countries; however, the majority of these deaths could be avoided with adequate obstetric care. Analyzing severe maternal outcomes (SMO) has been a major approach for evaluating the quality of the obstetric care provided, since the morbid events that lead to maternal death generally occur in sequence. The objective of this study was to analyze the clinical profile, management, maternal outcomes and factors associated with SMO in women who developed PPH and were admitted to an obstetric intensive care unit (ICU) in northeastern Brazil. Methods This retrospective cohort study included a non-probabilistic, consecutive sample of postpartum women with a diagnosis of PPH who were admitted to the obstetric ICU of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) between January 2012 and March 2020. Sociodemographic, biological and obstetric characteristics and data regarding childbirth, the management of PPH and outcomes were collected and analyzed. The frequency of maternal near miss (MNM) and death was calculated. Multiple logistic regression analysis was performed to determine the adjusted odd ratios (AOR) and their 95% confidence intervals (95% CI) for a SMO. Results Overall, 136 cases of SMO were identified (37.9%), with 125 cases of MNM (34.9%) and 11 cases of maternal death (3.0%). The factors that remained associated with an SMO following multivariate analysis were gestational age ≤ 34 weeks (AOR = 2.01; 95% CI: 1.12–3.64; p  < 0.02), multiparity (AOR = 2.20; 95% CI: 1.10–4.68; p  = 0.02) and not having delivered in the institute (AOR = 2.22; 955 CI: 1.02–4.81; p  = 0.04). Conclusion Women admitted to the obstetric ICU with a diagnosis of PPH who had had two or more previous deliveries, gestational age ≤ 34 weeks and who had delivered elsewhere were more likely to have a SMO.

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.

Objective: The objective of this study is to describe the characteristics of women who experienced severe maternal outcomes (SMO: maternal near-miss or maternal death) in an obstetric intensive care unit (ICU).Methods: A cross-sectional study was carried out including pregnant or postpartum women up to 42 days of childbirth admitted to the obstetric ICU at one reference centre in the northeast of Brazil, for any clinical, surgical, or obstetric complication, with data collected between October 29, 2018, and September 30, 2019. Maternal characteristics, details on admission to the ICU, pregnancy outcomes, and causes for ICU admission were compared between groups with SMO or with the remaining group, potential life-threatening conditions (PLTCs). A significance level of 5% was adopted.Results: During the study period, 309 women were admitted to the obstetric ICU and considered eligible for the study. SMO was observed in 150 (48.5%) of these women. Of these, 8 (2.6%) were maternal deaths, and 142 (45.9%) presented one or more near-miss criteria. Most women with a SMO were admitted for direct obstetric causes such as hypertensive syndromes, postpartum haemorrhage, or puerperal infection. SMO was associated more frequently with puerperal infection.Conclusion: SMO is a commonly occurring outcome in an obstetric ICU with great possibility of treatment. Direct obstetric causes such as hypertension syndromes, postpartum haemorrhage, and puerperal infection were the most prevalent causes in the development of this outcome. Puerperal infection was the condition most associated with SMO.

An open randomized clinical trial was developed at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) in Recife and at Petronila Campos Municipal Hospital in São Lourenço da Mata, both in Pernambuco, northeastern Brazil, including 226 low-risk pregnant women bearing a single, full-term, live fetus after delayed cord clamping, 113 randomized to placental cord drainage and 113 to a control group not submitted to this procedure. Women incapable of understanding the study objectives and those who went on to have an instrumental or cesarean delivery were excluded. Duration of the third stage of labor did not differ between the two groups (14.2±12.9 versus 13.7±12.1 minutes (mean ± SD), p = 0.66). Likewise, there was no significant difference in mean blood loss (248±254 versus 208±187ml, p = 0.39) or in postpartum hematocrit levels (32.3±4.06 versus 32.8±4.25mg/dl, p = 0.21). Furthermore, no differences were found between the groups for any of the secondary outcomes (postpartum hemorrhage >500 or >1000ml, therapeutic use of oxytocin, third stage >30 or 60 minutes, digital evacuation of the uterus or curettage, symptoms of postpartum anemia and maternal satisfaction). Placental cord drainage had no effect in reducing duration or blood loss during the third stage of labor. ClinicalTrials.gov: www.clinicaltrial.gov, NCT01655576.

Changes during the puerperium are still unclear, particularly in women with hypertension. The choice of antihypertensives, both to control very high blood pressure episodes and to keep blood pressure stable, also requires further elucidation. Currently, there are no clear data to guide the decision for the choice of postpartum antihypertensives. Captopril plays an important role in the treatment of very high blood pressure episodes and may be used postpartum. Clonidine has been used as an alternative in pregnant or postpartum women with contraindications to captopril, with satisfactory effect. The objective of the present study was to evaluate the effectiveness and safety of clonidine compared to captopril for treating severe postpartum hypertension. A randomized, drug-controlled, triple-blind clinical trial evaluating postpartum women receiving captopril or clonidine. Inclusion criteria consisted of: women with hypertensive disorders of pregnancy systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg], requiring magnesium sulfate. Exclusion criteria were: heart disease, smoking, illicit drug use, contraindications to captopril, clonidine or oral medication, and having used captopril/clonidine previously. The primary outcome was the frequency of very high blood pressure episodes while in the obstetric intensive care unit. A total of 90 postpartum women met the study inclusion criteria, with 45 randomized to each group. There were fewer very high blood pressure episodes during hospitalization (2.1 ± 2.1 vs. 3.5 ± 4.7, p = 0.08), greater percentage reduction in SBP (14.0% ± 8.6% vs. 10.8% ± 8.8%, p = 0.08) and fewer women requiring sodium nitroprusside (2.3% vs. 13.3%; RR: 0.17; 95%CI: 0.02-1.39; p = 0.06) in the clonidine group compared to the captopril group; however, these differences were not significant. The groups were similar regarding daily mean SBP or DBP; however, on the third postpartum day, mean SBP was lower in the clonidine compared to the captopril group (151.9 ± 11.8 mmHg vs. 158.1 ± 13.6 mmHg, p = 0.02). Although not statistically significant, adverse reactions were more common in the captopril group (28.8%) compared to the clonidine group (18.6%). Clonidine and captopril represent safe, effective treatments for severe postpartum hypertension. clinicaltrials.gov: www.clinicaltrial.gov, NCT01761916.

Background Despite all the evidence corroborating the selective use of episiotomy and although routine use of the procedure is contraindicated, there are no evidences corroborating if episiotomy is necessary in any circumstance. The present clinical randomized trial was performed to compare maternal and perinatal outcomes in women submitted to a non-episiotomy protocol versus one of selective episiotomy. Methods An open-labelled, randomized clinical trial was carried out in a tertiary teaching hospital in Recife, Northeastern Brazil. Women in labor with a full-term live foetus, dilatation of 6 to 8 cm and cephalic presentation (vertex position) were included. Exclusion criteria consisted of bleeding disorders and an indication for a caesarean section. After signing the consent form, 241 women were randomized to a non-episiotomy protocol (the experimental group) or to a selective episiotomy group (the control group). No episiotomies were to be performed in the experimental group except under exceptional circumstances. In the control group, selective episiotomies were to be performed in accordance with the healthcare professionals’ clinical judgement. Maternal and perinatal outcomes were evaluated. Ratio Risk (RR) and the 95% confidence interval (95% CI) were calculated for our outcomes. Results The analysis include 115 women assigned to a non-episiotomy protocol and 122 to selective episiotomy. There was no difference between the two groups with respect to maternal or perinatal outcomes. The episiotomy rate was similar (two cases in each group, about 1.7%), as was the duration of the second stage of labor, the frequency of perineal tears, severe perineal trauma, need for perineal suturing and blood loss at delivery. Conclusions A non-episiotomy protocol appears to be safe for mother and child, and highlights the need to investigate whether there is, in fact, any indication for this procedure. Trial registration This trial was registered at ClinicalTrials.gov under reference number ( NCT02178111 ).

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.