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Objective: To study the adverse maternal and perinatal outcomes in women with severe pre‐eclampsia (SPE) among different ranges of proteinuria. Methods: This prospective cohort study was conducted in Jawaharlal Institute of Postgraduate Medical Education and Research, India. After obtaining informed written consent, the 202 singleton women fulfilling the criteria of severe features of pre‐eclampsia were stratified based on the value of urine protein‐creatinine ratio (UPCR) as mild, moderate, severe, and massive proteinuria during pregnancy. Clinical outcomes were assessed and patients were followed up until 12 weeks postpartum to identify persistent proteinuria and hypertension. Results: Of the 202 women with SPE, adverse maternal outcomes were seen in 34.65% (n = 70) and adverse perinatal outcomes in 75.74% (n = 153). The demographic and clinical factors were similar among women with increasing severity of proteinuria, except for mean systolic blood pressure, serum creatinine and total serum protein. UPCR was found to have a significant correlation with composite adverse perinatal outcome (P < 0.001) and individual outcomes of neonatal intensive care unit admission for >48 h (P = 0.01) and neonatal sepsis (P = 0.02) but not adverse maternal outcomes (P = 0.201). The optimum UPCR cutoff for adverse perinatal outcomes was 1.6 (sensitivity, 73.2%; specificity, 52.7%). In addition, 14.85% of the women had a persistently elevated UPCR and 3.96% had hypertension at 3 months postpartum. Conclusion: In women with SPE, severe and massive proteinuria were related to composite adverse perinatal outcome but not composite adverse maternal outcome. Moreover, antenatal 24‐h proteinuria was significantly associated with persistent proteinuria. Significant proteinuria in women with SPE poses a risk for chronic renal dysfunction, requiring follow‐up. Synopsis: In women with severe pre‐eclampsia, high antenatal proteinuria was associated with adverse perinatal outcomes and persistent proteinuria, requiring long‐term renal follow‐up. [ABSTRACT FROM AUTHOR]

India is a vast and diverse country with a complex healthcare scheme that faces significant challenges in providing quality care to its population. Obstetric care is a complex area of healthcare. The history of clinical care pathways in obstetric care reflects a continued effort to improve the quality and safety of healthcare for mothers and infants. This comprehensive review provides an overview of clinical care pathways in obstetric care. It sheds light on the current evidence supporting the use of clinical care pathways for the management of anaemia during pregnancy, Gestational Diabetes Mellitus (GDM), pre-eclampsia, and Preterm Labour (PTL). The primary aim of this review is to recognise the accessibility and strength of evidence for the use of clinical care pathways in the management of common complications of pregnancy. [ABSTRACT FROM AUTHOR]

Objective: To compare placental findings in women with and without pre‐eclampsia. Design: The PURPOSe study included women with stillbirths, women with preterm births and women at term as controls. The placenta of each case was evaluated using the Amsterdam criteria. Setting: Two sites and five tertiary care hospitals of south Asia (Three in India and two in Pakistan). Population: Pregnancies in India and Pakistan with placental histology including women with documented hypertension and documented proteinuria and women with neither hypertension nor proteinuria. Methods: We compared the placental findings of the two groups using the Amsterdam criteria and further evaluated the placental findings in women with and without pre‐eclampsia who had a stillbirth, preterm live birth, or term live birth (control). Main outcome measures: The main outcome measures were the frequency of maternal and fetal vascular malperfusion and the frequency of placental inflammation and its components, chorioamnionitis, funisitis, villitis and intervillitis in women with and without pre‐eclampsia. Results: A total of 733 women had pre‐eclampsia and 2334 women had neither hypertension nor proteinuria. In the placentas of women with pre‐eclampsia, 57.3% had maternal vascular malperfusion compared with 37.1% in women without pre‐eclampsia (p < 0.0001). There was not a significant difference in the prevalence of fetal vascular hypertension between mothers with (17.1%) and without (14.8%, p = 0.6118) pre‐eclampsia. When placentas were classified as 'histologically normal' or not, 61.3% of those from pre‐eclamptic pregnancies were classified as abnormal, whereas if there was no pre‐eclampsia, only 45.0% were classified as histologically abnormal (p < 0.0001). We also considered rates of placental maternal vascular malperfusion in women with and without pre‐eclampsia with stillbirth, preterm neonatal death, and term live birth. In women at term with no pre‐eclampsia, 16.7% of the placentas had features of maternal vascular malperfusion. This occurred in 79.9% of women with stillbirths with pre‐eclampsia compared with 51.8% of those without pre‐eclampsia. Maternal vascular malperfusion was present in 49.7% of preterm live births with pre‐eclampsia compared with 33.8% without pre‐eclampsia. We also evaluated the inflammatory lesions by whether the mother had or did not have pre‐eclampsia. When all inflammatory lesions were considered, women with pre‐eclampsia had significantly fewer inflammatory lesions than those women without pre‐eclampsia (17.1% versus 23.6% p = 0.001). Each of the specific inflammatory lesions was less common in placentas of women with pre‐eclampsia than those with chorioamnionitis (16.1% versus 21.9%, p = 0.004) and funisitis (1.5% versus. 5.1%, p = 0.0004). Conclusions: Of placental lesions in women with pre‐eclampsia, maternal vascular malperfusion was the most common. Inflammatory lesions were less common in women with pre‐eclampsia. [ABSTRACT FROM AUTHOR]

Background and objective: Incidence of twin pregnancy has grown from the past 20 years due to early detection by USG and increased use of ovulation inducing drugs and ART. There is significant risk of maternal and perinatal morbidity due to associated complications like re-eclampsia, anemia, premature delivery, malpresentations, PPROM in twin gestation. Active and timely intervention and strict vigilance helps in improving the maternal and perinatal outcome. Methods: A prospective study was carried out from March 2021-December 2022 in the Obstetrics and Gynaecology Department at Siddhartha Medical College, Vijayawada, Andhra Pradesh, India. The study was approved by Institute Ethics Committee. 90 antenatal women with twin pregnancy more than 28 weeks attending antenatalop, labour ward were included. Results: Maternal complications most common is pre-eclampsia in 35.5% cases, anemia is seen in 30% cases, antepartum eclampsia seen in 3% cases, premature delivery in 70% cases, malpresentations in 53.6%, pph in 30%, postpartum eclampsia in 8.8%cases. Low birth weight is 62.2%, perinatal mortality rate is 6.32% and neonatal mortality rate is 4.87.Most common cause of neonatal death is prematurity with RDS. Conclusion: Early identification of twin gestation Chorionicity, is important to identify the twins at risk for complications. Good antenatal care, early detection of complications, timely intervention, and prevention of pre term labour, strict intrapartum care and good neonatal intensive care services reduces the maternal and prenatal morbidity and mortality to a significant extent. [ABSTRACT FROM AUTHOR]

Objective: This cross-sectional study aimed to assess the predictive accuracy of uterine artery Doppler sonography in the first and second trimesters for pre-eclampsia and intrauterine growth restriction (IUGR) in pregnant women. Methods: The study included 280 pregnant women from two hospitals in Davanagere, Karnataka, India. Data collection spanned from January 2021 to June 2022. Uterine artery Doppler sonography was performed, and demographic and clinical information was collected. Statistical analysis was conducted to evaluate the associations and predictive values of uterine artery Doppler parameters. Results: The study revealed that age and primiparity were not significantly associated with IUGR. In the first trimester, an increased uterine artery pulsatility index (PI) showed a statistically significant association with pre-eclampsia. However, the sensitivity of uterine artery PI in predicting pre-eclampsia during the first trimester was low, while the specificity was high. In the second trimester, the presence of an early diastolic (ED) notch in the uterine artery Doppler waveform was significantly associated with pre-eclampsia, with moderate sensitivity and specificity. Moreover, an increased uterine artery PI in the second trimester was associated with both pre-eclampsia and IUGR, although the specificity was lower than the sensitivity. Conclusion: Uterine artery Doppler sonography shows potential as a non-invasive tool for predicting pre-eclampsia and IUGR in pregnancy. However, its utility as a standalone predictive test is limited, and further research is needed to explore its integration with other clinical parameters and biomarkers. These findings contribute to the existing knowledge on uterine artery Doppler sonography and highlight the importance of early detection and monitoring of high-risk pregnancies. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of using a combination of transcervical Foley catheter and sublingual misoprostol with sublingual misoprostol alone for induction of labor (IOL) in women with pre‐eclampsia between 28 and 34 weeks of pregnancy. Methods: This randomized controlled trial was conducted on women with pre‐eclampsia at 28–34 weeks of pregnancy, with unfavorable cervix, admitted to a tertiary hospital in south India. They were randomized to receive either a combination of transcervical Foley catheter and sublingual misoprostol, or sublingual misoprostol alone. Vaginal birth within 24 h of induction, induction to delivery interval, and neonatal morbidity/mortality were the main outcome measures. Results: Vaginal birth within 24 h was higher with the combination of Foley catheter and sublingual misoprostol compared with sublingual misoprostol alone (60% versus 41.4%, P = 0.028). Overall vaginal delivery rates were comparable between the groups (90% versus 80%, P = 0.051). There was no difference in number of doses of misoprostol, and induction to delivery interval between groups. After excluding those with lower likelihood of neonatal survival, live birth rates, mean birth weight, and neonatal intensive care unit admission rates were similar in both groups. Conclusions: Combination of transcervical Foley catheter and sublingual misoprostol was found to be more effective in achieving vaginal birth within 24 h compared with sublingual misoprostol for IOL in pre‐eclampsia between 28 and 34 weeks of pregnancy. Trial Registration Number: CTRI/2018/09/015766; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=27984. Synopsis: Combination of Foley catheter and sublingual misoprostol appears to be more effective than sublingual misoprostol alone for induction of labor in pre‐eclampsia.T [ABSTRACT FROM AUTHOR]

Background: Hypertension is one of the most common medical disorders complicating pregnancy. In India, high blood pressure contributes to 7.1% of maternal deaths. This study was carried out to describe the characteristics and pregnancy outcomes of patients presenting with eclampsia or pre-eclampsia to a secondary care hospital in rural India. Methods: Patients diagnosed with pre-eclampsia or eclampsia between January 2018 and April 2021 were identified and included in the study. Medical records were searched and general patient characteristics, obstetrical history, information about the antenatal period, mode of delivery and outcomes were documented and analysed. Results: Among the 3651 women who delivered in this hospital during this time period, 2.3% (n = 83) presented with eclampsia and 1.9% (n = 71) with pre-eclampsia. More than 50% of the women delivered by lower segment caesarean section among both the eclamptics and pre-eclamptics. The stillbirth rate among those with either pre-eclampsia or eclampsia was 1 per 1000. The number of low birth weight babies born to those presenting with eclampsia (66.7%) was significantly more than those presenting with pre-eclampsia (48.6%). Eclampsia/pre-eclampsia accounted for 21% of all maternal deaths with a case fatality rate of 2.6%. Conclusions: This study identified that in this setting the patients presenting with eclampsia were much higher than those presenting with pre-eclampsia which is in stark contrast to the status even in developing countries. This could be an important finding indicating poorer health-seeking behaviour among the population and will need more studies on various interventions to change this status. [ABSTRACT FROM AUTHOR]

As an example of a low- and middle-income country (LMIC), India ranks pre-eclampsia among the top three causes of maternal mortality, following haemorrhage and infections. It is one of the primary concerns for maternal and perinatal health in LMICs. Many LMICs lack clear consensus and guidelines for the prevention, diagnosis, and management of hypertensive disorders in pregnancy, including pre-eclampsia. The International Society for the Study of Hypertension in Pregnancy 2021 guidelines address LMIC applications, offering customisable solutions. Atypical presentations of pre-eclampsia contribute to diagnostic delays, resulting in additional adverse maternal and perinatal outcomes. Implementing management strategies faces challenges in both urban and rural settings. Adapting global research involving local populations is imperative, with the potential for cost-effective adoption of international guidelines. Prevention, early diagnosis, and education dissemination are essential, involving healthcare providers and advocacy initiatives. Encouraging government investment in pre-eclampsia management as a public health initiative is important. This article explores socio-economic, cultural, and legislative factors influencing the management of pre-eclampsia in LMICs, addressing emerging challenges and potential partnerships for healthcare provision., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Aim: To evaluate the association of GDM and pre-eclampsia in women with obstetric cholestasis., Materials and Methods: Pregnant women with > 28 weeks gestation attending ANC, OPD and labor room of J.N.M.C.H, AMU, Aligarh UP (India) from 2020 to 2022 were included in the study after taking informed consent and ethical approval from the Institute. Women were divided into 2 groups, i.e. group 1 having 200 women with IHCP and group 2 having 200 healthy pregnant women; both the groups were followed up for the development of GDM and pre-eclampsia., Results: A statistically significant association was observed between IHCP and development of GDM [26.5% and odds ratio (OR) 1.64] and pre-eclampsia (17% and OR: 1.95) (p < 0.05), an also GDM and pre-eclampsia were found to be significantly associated with the severity of cholestasis (p < 0.05). Thus, on calculating OR, we found higher odds of developing GDM and pre-eclampsia in IHCP group with raised serum bile acid levels, maximum at 60 μmol/L level as compared to 10-40 μmol/L (GDM: OR: 8.647 and pre-eclampsia: OR: 6.303). Induction and cesarean rates were significantly higher in IHCP group (p < 0.05)., Conclusion: Our study concludes significant association of IHCP with GDM and pre-eclampsia as all three shares common pathogenetic pathways and greater risk of development at higher serum bile acid levels., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Eclampsia is a major cause of perinatal mortality. There is a need for studies that will correlate maternal factors and perinatal outcome, which will provide potential strategies to improve fetal outcomes in pregnancies complicated by eclampsia. Aims and Objectives: This study aims to study perinatal outcome of babies born to mothers with antepartum eclampsia and to correlate outcomes with convulsion delivery interval. Materials and Methods: A study included 200 patients diagnosed and managed as antepartum eclampsia in the Department of Obstetrics and Gynaecology in MGM Medical College, Indore. A detailed pro forma was prepared and was filled with patient’s information, investigations, treatment, and birth details. The final outcome of both, the mother and her newborn, including stillbirths and early neonatal deaths was included in the study and the perinatal outcome was correlated with convulsion delivery interval. Results: Incidence of antepartum eclampsia in our study was 2.1%. About 86.4% of women lack regular antenatal care at health care center. Only 7% of women delivered within 6 h of onset of convulsion. Case fatality rate was found to be 13%. There were 59.5% premature deliveries. Perinatal mortality (stillbirth and early neonatal deaths) was 42.5%. Significant association was found between convulsion delivery interval and perinatal outcome (P<0.05). Furthermore, association between use of multiple antiepileptic agents and perinatal outcomes was statistically significant. Conclusion: Eclampsia being a major cause of perinatal mortality need early diagnosis, prompt referral from peripheral health centers, and timely intervention for improvising both perinatal and maternal outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Pre-eclampsia is a multisystem multifactorial disease unique to pregnancy with unknown aetiology which is characterized by blood pressure ≥140/90 mmHg after 20 weeks of gestation associated with proteinuria ≥300 mg/24-hour urine specimen. It complicates about 2-10% of pregnancies worldwide. Objectives: To determine the prevalence and evaluate feto-maternal outcomes of pre-eclampsia. Methods: This was a retrospective study conducted at Amrita Institute of Medical Sciences, (AIMS) Kochi from 1 August 2017 to 31 July 2018. This study was done by retrospective analysis of the delivery register (Labour room) and hospital medical records. Results: The prevalence of pre-eclampsia is 2.5% and the major feto-maternal complications are impending eclampsia, maternal distress, placental abnormalities. Conclusion: The outcomes can be improved with prompt recognition and management, so pregnant women need to have routine health screenings. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate the incidence, clinical characteristics, and outcomes of acute kidney injury (AKI) during pregnancy in Indian population. Materials and methods: A prospective observational study was conducted in pregnant patients admitted to Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India. Acute kidney injury was assessed using Risk, Injury, Failure, Loss of function, and End-stage renal disease (RIFLE) criteria. Patients were analyzed on the basis of demographic data, detailed history, clinical examination, and laboratory investigations. The primary outcome was maternal renal outcome, including return to normal renal function and progression to chronic kidney disease (CKD). The secondary outcomes included the mode of delivery, complications of pregnancy, intensive care unit (ICU) admission, and maternal death. Results: A total of 51 patients with an average age of 29.5 years were included in the present study. About 49.9% of subjects had severe anemia and 41.2% were primigravida. The main cause of AKI was pre-eclampsia and postpartum hemorrhage. There was a marked improvement in renal outcome with 33 patients having complete renal recovery and six patients developed CKD was observed during three months follow-up period. The peaked median value of blood urea was 62.0 mg% in patients with normal renal function, 178.5 mg% in those with CKD and 120.0 mg% in expired patients (P=0.001). A statistically significant change in serum potassium (P=0.010) and creatinine levels (P<0.001) was observed during the follow-up period. Liver enzymes, including serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase, were high in all patients at the time of admission, but decreased to normal on follow-up. Conclusion: Our study indicates that pregnancy-related AKI patients present with multiorgan complications and many of them require mechanical ventilation and renal replacement therapy. Most of these patients have poor outcome. Hence, the management of pregnancy-related AKI presents a challenge that requires proper evaluation of causative factors to facilitate appropriate treatment. [ABSTRACT FROM AUTHOR]

Background: Pre-eclampsia and migraine share some similar aspects of pathophysiology such as vascular function, platelet activation, and enhanced clotting. A few observational studies from different demographics showed that pregnant women with a history of migraine were at higher risk of developing pre-eclampsia. However, there is no such evidence available from the Indian context. Hence, a hospital-based case-control study was conducted among Indian women to determine the association between migraine and pre-eclampsia., Method: It was a single-centre case-control study in a tertiary care hospital in India. Cases were pregnant women with clinically diagnosed pre-eclampsia, and controls were normotensive pregnant women. Migraine was diagnosed with a questionnaire adapted from the "International Classification of Headache Disorders (ICHD), 3rd Edition" by the International Headache Society, (IHS). We performed logistic regression to explore the association between migraine and pre-eclampsia., Result: One hundred sixty-four women (82 women per group) were enrolled. The mean age among the cases (24.5 years, standard deviation of 2.4 years) was slightly higher than the mean age of the controls (23.5 years, standard deviation of 2.5 years) with a p-value of 0.006. We found that women with a history of migraine were more likely to develop pre-eclampsia (Adjusted Odds Ratio 6.17; p-value < 0.001, 95% Confidence Interval of 2.85 to 13.62)., Conclusion: The current findings suggest a significant association between migraine and pre-eclampsia aligning with previous study findings; nevertheless, larger follow-up studies including women from different states in India are needed., (© 2024. The Author(s).)

Objectives: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013–15. Data description: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare. [ABSTRACT FROM AUTHOR]

Background: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity globally. Planned delivery between 34+0 and 36+6 weeks may reduce adverse pregnancy outcomes but is yet to be evaluated in a low and middle-income setting. Prior to designing a randomised controlled trial to evaluate this in India and Zambia, we carried out a 6-month feasibility study in order to better understand the proposed trial environment and guide development of our intervention. Methods: We used mixed methods to understand the disease burden and current management of pre-eclampsia at our proposed trial sites and explore the acceptability of the intervention. We undertook a case notes review of women with pre-eclampsia who delivered at the proposed trial sites over a 3-month period, alongside facilitating focus group discussions with women and partners and conducting semi-structured interviews with healthcare providers. Descriptive statistics were used to analyse audit data. A thematic framework analysis was used for qualitative data. Results: Case notes data (n = 326) showed that in our settings, 19.5% (n = 44) of women with pre-eclampsia delivering beyond 34 weeks experienced an adverse outcome. In women delivering between 34+0 and 36+6 weeks, there were similar numbers of antenatal stillbirths [n = 3 (3.3%)] and neonatal deaths [n = 3 (3.4%)]; median infant birthweight was 2.2 kg and 1.9 kg in Zambia and India respectively. Lived experience of women and healthcare providers was an important facilitator to the proposed intervention, highlighting the serious consequences of pre-eclampsia. A preference for spontaneous labour and limited neonatal resources were identified as potential barriers. Conclusions: This study demonstrated a clear need to evaluate the intervention and highlighted several challenges relating to trial context that enabled us to adapt our protocol and design an acceptable intervention. Our study demonstrates the importance of assessing feasibility when developing complex interventions, particularly in a low-resource setting. Additionally, it provides a unique insight into the management of pre-eclampsia at our trial settings and an understanding of the knowledge, attitudes and beliefs underpinning the acceptability of planned early delivery. Plain language summary: Pre-eclampsia is a complication of pregnancy and is one of the major causes of pregnancy-related death and serious illness for women and babies around the world. Most of these deaths occur in lower income countries in Africa and Asia. Signs of pre-eclampsia include high blood pressure and protein in the urine. It is unpredictable and may affect different organs within the woman, leading to seizures, stroke and even death if not well managed. It can also affect the baby's growth and in severe cases lead to stillbirth. We know that birth of the baby (and placenta) is the only cure for pre-eclampsia. Currently, it is recommended by the World Health Organisation that all women with pre-eclampsia are offered planned early birth once they reach 37 weeks of pregnancy, unless they develop severe complications needing intervention sooner than this. However, research from higher income countries has shown that planned early birth from 34 weeks of pregnancy may reduce serious complications in the woman, without causing harm to the baby. We are designing a clinical trial to find out whether, in women with pre-eclampsia between 34 and 37 weeks of pregnancy, it is better to offer planned early birth or to offer close monitoring until either they reach 37 weeks, or a complication develops requiring emergency intervention. Before designing this trial, we carried out a study in order to establish whether the main trial would be possible, and acceptable to the local community, at our potential trial sites in India and Zambia. [ABSTRACT FROM AUTHOR]

Objective: To determine the performance of a glycosylated fibronectin (GlyFn) point-of-care (POC) test for pre-eclampsia (PE) in a large Southeast Asian cohort (India) in comparison to previously described biomarkers.Design: A total of 798 pregnant women at ≥20 weeks of gestation were enrolled in a prospective case-control study. Study participants included 469 normotensive women with urinary mg protein/mmol creatinine ratio <0.3, 135 with PE (hypertension with urinary mg protein/mmol creatinine ratio ≥0.3) and 194 with gestational hypertension (hypertension with urinary mg protein/mmol creatinine ratio <0.3).Methods: GlyFn levels were determined using a POC device and PIGF, sFlt-1 and PAPPA2 levels were determined by immunoassay. Performance was assessed using logistic regression modelling and receiver-operating characteristic (ROC) curves. Classification performance and positive and negative predictive values are reported at specific thresholds.Results: Increased levels of GlyFn, soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy-associated placental protein A2 (PAPPA2), and decreased levels of placental growth factor (PlGF) were significantly associated (P < 0.01) with clinically defined PE. Area under the ROC (AUROC) values with 95% confidence intervals were: GlyFn, 0.99 (0.98-0.99); PlGF, 0.96 (0.94-0.98); sFlt-1, 0.86 (0.83-0.89); and PAPPA2, 0.96 (0.94-0.97). Of subjects with GH, 48% were positive for more than two PE biomarkers, and 70% of these delivered preterm.Conclusions: The Lumella™ GlyFn POC test has been validated in a low/middle-income country setting for PE diagnosis and may be a useful adjunctive tool for early identification, appropriate triage, and improved outcomes.Tweetable Abstract: The Lumella™ point-of-care test had excellent performance in diagnosing PE in a large Southeast Asian cohort. [ABSTRACT FROM AUTHOR]

Objective: To assess the prevalence of new-onset postpartum chronic hypertension (PPCH) after pre-eclampsia and to determine the factors are associated with it.Methods: This study was conducted in a tertiary center in south India, between June 2018 and February 2019, consisting of pre-eclamptic women who were recruited as part of an ongoing cohort and had completed at least 3 months of postpartum follow-up. Demographic, medical, and laboratory details were collected. Primary outcome was a diagnosis of new-onset PPCH at 3 months.Results: PPCH at 3 months was noted in 32 (18.1%) women. During postnatal follow-up, 2 (1.1%) women experienced hemiplegia from stroke and 19 (10.7%) had elevated serum creatinine levels (>1.1 mg/dL). On multivariate analysis, advancing maternal age (adjusted odds ratio [aOR] 1.10, 95% confidence interval [CI] 1.01-1.21), multiparity (aOR 2.79, 95% CI 1.07-7.24), and eclampsia (aOR 3.07, 95% CI 1.03-9.13) increased the risk of PPCH at 3 months postpartum.Conclusion: One in five women present with a diagnosis of new-onset PPCH within 3 months postpartum in a cohort of predominantly preterm and/or severe pre-eclampsia. A significant but weak association of PPCH with peripartum clinical characteristics was noted. The role of biochemical, hemodynamic, and echocardiographic biomarkers should be evaluated for prediction of PPCH after pre-eclampsia in future studies. [ABSTRACT FROM AUTHOR]

Early onset pre-eclampsia (pre-eclampsia at less than 34 gestational weeks) is a severe form of preeclampsia; in addition, some women may also develop nephrotic range proteinuria. De novo diagnosis of lupus nephritis (LN) in pregnancy is challenging as it may present with features similar to commonly occurring preeclampsia. We report three cases of early onset pre-eclampsia with nephrotic range proteinuria and subsequent diagnosis of LN at the Women and Children hospital attached to Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, between 2014 and 2017. These cases highlights the need for further evaluation of the association between nephrotic-range proteinuria and early onset pre-eclampsia. The index of suspicion for underlying LN of these type of cases should be high. Earlier detection of LN will prompt better management that can avert or delay short- and long-term morbidity. [ABSTRACT FROM AUTHOR]

Background: Studies of vitamin D (VD) physiology suggest that effects of vitamin D deficiency (VDD) could be much broader than rickets including cardiovascular disease, cancers, diabetes, infection, and allergy and pregnancy complications. Data regarding the prevalence of hypovitaminosis in pregnancy are scanty especially in north eastern part of India. Therefore, this study has undertaken with the intention to find out prevalence and outcome of hypovitaminosis of VD in pregnancy. Materials and Method: In total, 177 pregnant women with singleton pregnancy, <16 weeks of gestational age, visited to antenatal clinic of our institute were consecutively enrolled for the study. The serum VD was estimated by Beckman coulter unicel DXI immunoassay system using the principle of Chemiluminescence. Incidence of vitamin deficiency and insufficiency calculated. VDD was defined as 25(OH)D levels in blood <20 ng/mL, and insufficiency of VD was defined as 25(OH)D levels <32 ng/mL. Antenatal complications, such as intrauterine growth restriction (IUGR), oligohydramnios, pre-eclampsia, preterm labor, gestational diabetes, if any, were noted. Labor and delivery information including induction of labor, mode of delivery, and newborn birth weight were noted. Result: In total, 177 women recruited for the study. Mean age and parity of the subjects were 26.71 ± 9.96 and 2.10 ± 1.8, respectively. For detailed statistical analysis, women were divided into three groups depending upon their VD levels: deficiency group [25(OH)D level <20 ng/mL], insufficiency group [25(OH)D level <32 ng/mL], and sufficient group [25(OH)D level >32 ng/mL]. VDD was present in 84.18% subjects. VD insufficiency was present in 12.44% of cases. There is association of preeclampsia, cesarean section, and low birth weight babies with lower level of VD. Conclusion: This study showed that the prevalence of VDD in pregnancy is astonishingly high till now there is no guideline to screen antenatal women for VDD. As the test is costly even, offering it to all at-risk women may not be cost effective compared with offering universal supplementation, particularly as treatment is regarded as being very safe. [ABSTRACT FROM AUTHOR]

Objective: To compare the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and platelet indices between women with pre-eclampsia and normotensive pregnant women.Methods: A cross-sectional study conducted from January to July 2017 at a tertiary care hospital in Delhi, India. The study compared pregnant women aged 18-40 years with pre-eclampsia diagnosed at term with healthy pregnant women matched for gestational age. Venous blood samples were drawn and complete blood count was analyzed. The parameters recorded were hemoglobin, red cell distribution width (RDW), platelet count, mean platelet volume (MPV), plateletcrit, and platelet distribution width.Results: There were 67 women included in each group. NLR was higher in women with pre-eclampsia compared with the control group (6.8 ± 7.6 vs 3.0 ± 0.98; P=0.001). Both PLR (14.18 ± 14.4 vs 9.54 ± 3.6; P=0.012) and MPV (9.45 ± 1.19 vs 9.02 ± 1.1; P=0.029) were higher in the study group compared with the control group. Platelet count was lower in pre-eclamptic women compared with the control group (188 ± 89.7 vs 200.1 ± 62.36; P=0.014). RDW was also higher in the study group (P=0.025).Conclusions: The present study found that the inflammatory markers NLR, PLR, RDW, and MPV were higher in women with pre-eclampsia. Measuring NLR and PLR may be useful in predicting pre-eclampsia among women at high risk during prenatal follow-up. [ABSTRACT FROM AUTHOR]

Objective: A study was carried out to evaluate the effects of metabolic syndrome components and oxidative stress factors among preeclamptic women from South West India.Study Design: A case-control study was carried out by enrolling fifty pre-eclampsia cases and hundred low-risk pregnant women within the age group of 18-40 years, at 28-34 weeks of pregnancy. The fasting glucose level, fasting insulin level, insulin resistance, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), malondialdehyde, the ferric reducing ability of plasma (FRAP assay), cardiac output and aortic wall distensibility were measured.Main Outcome Measures: There was a significant rise in the fasting blood glucose, fasting insulin, insulin resistance levels, total cholesterol, triglycerides, LDL, and antioxidant levels in pre-eclamptic women (p < 0.001). The cardiac output and aortic wall distensibility were observed to be low in the cases.Conclusion: We conclude that abnormal lipid metabolism and high lipid peroxide concentrations observed in pre-eclampsia may result in oxidative stress and vascular dysfunction. [ABSTRACT FROM AUTHOR]

Objective: To determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings.Design: Cost-consequence analysis of a previously reported multicentre, parallel, open-label randomised trial.Setting& Population: A total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre-eclampsia or hypertension, in two public hospitals in Nagpur, India.Methods: We performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider-side microcosting approach.Main Outcome Measures: Rates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode.Results: Induction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (-) $123.59 (-) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (-2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4-186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1-17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost-saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31-fold from $0.24 to $7.50 per 25 mcg tablet and remain cost-saving.Conclusion: Compared to Foley catheterisation for the induction of high-risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low-resource settings is required to determine their relative cost-effectiveness.Tweetable Abstract: Oral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension. [ABSTRACT FROM AUTHOR]

Introduction: Hypertensive Disorders of Pregnancy (HDP) are the major cause of maternal morbidity and mortality worldwide. The maximum burden of maternal mortality and morbidity is due to HDP and its related complications which is further followed by obstetric haemorrhage, pre-existing medical diseases, infections and abortions. Aim: To study the association between the serum uric acid level in hypertensive pregnant women and their association with maternal and foetal morbidity and mortality. Materials and Methods: It was a prospective observational study conducted at BLDE (Deemed to be) University, Shri BM Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka, India from January to June 2019. A total of 165 pregnant women with HDP were included (44 (27%) had Gestational Hypertension (GH); 86 (52%), Pre-eclampsia (PE) and 35 (21%) eclampsia) in each group in the study and they were subjected for obstetric history, examination and laboratory evaluation. The laboratory evaluation included complete blood count, liver function test, renal function test, serum uric acid level and urine albumin, sugars and microscopy. The maternal and foetal outcomes were measured, which included mode of delivery, Neonatal Intensive Care Unit (NICU) admission, neonatal outcomes in terms of preterm or term delivery, intrauterine death, fresh still born, neonatal deaths. Results: A total of 165 cases with HDP were enrolled in the study. Mean serum uric acid level in GH, PE and eclampsia group was 5.13±1.32, 5.34±1.4, 6.05±1.67, respectively. A total of 118 participants presented at term and 47 were preterm (11 in GH, 20 in PE and 16 in eclampsia group). About 103 (62.42%) had vaginal delivery and 62 (31.51%) underwent caesarean section (14 in GH, 28 in PE and 20 in eclampsia group). All the perinatal deaths occurred were in women with PE (n=5) and eclampsia (n=2) and was not statistically analysed. Conclusion: Present study shows that increased levels of maternal serum uric acid levels were associated with PE and eclampsia compared to GH patients and were associated with adverse foetal outcomes and increase in the instrumental and operative interventions. [ABSTRACT FROM AUTHOR]

Objective: To observe whether induction of labor (IoL) among women with severe pre-eclampsia (PE) can be expedited by initiating oxytocin early (after 6 h) than after 12 h following cervical ripening with a combined method., Methods: Women with severe PE and Bishop's < 6 (n = 96) were randomized into two groups. All women received cervical ripening with a combined method (intracervical Foley's plus dinoprostone gel 0.5 mg) following which Group 1 women received oxytocin after 6 h (with Foley's in-situ) and Group 2 after 12 h (after removing Foley's) RESULTS: Majority were nulliparous (63% in group 1 and 77% in group 2) and the mean gestation was similar (35.3 ± 2.98 weeks in group 1 and 35.5 ± 3.09 in group 2). Nearly half the women had partial HELLP/ HELLP (47.9% and 54.1%; in groups 1 and 2, respectively). The induction-delivery interval (IDI) was significantly reduced in group 1 (16 h 6 min vs 22 h 6 min in group 2; p = 0.001). The cesarean section (CS) rate was 37.5% in group 1 and 31.3% in group 2 (p = 0.525), but the study was underpowered to assess this outcome. The neonatal outcome was similar, 92/96 neonates were discharged after a hospital stay of 3-52 days. There were 4 neonatal deaths (1 in group 1 and 3 in group 2) of extreme or very preterm neonates (27-30 + 6 wks) with birth weight of 735-965 gm., Conclusion: Among women with severe PE undergoing IoL, initiating oxytocin 6 h after cervical ripening with a combined method reduced the IDI significantly as compared to initiating it after 12 h, with a similar CS rate and neonatal outcome., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.)

Maternal death is defined by the World Health Organization (WHO) as "the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. The world maternal mortality rate has declined 44% since 1990, but still every day 830 women die from pregnancy or childbirth related causes. Most of these deaths and injuries are entirely preventable. The United Nations Population Fund (UNFPA) estimated that 289,000 women died of pregnancy or childbirth related causes in 2013. The global maternal mortality ratio has fallen from 380 maternal deaths per 100,000 live births in 1990 to 210 deaths per 1,00,000 live births in 2013, and many countries halved their maternal death rates in the last 10 years. In India, 45,000 women die every year during childbirth according to WHO. The number of deaths in India during childbirth accounts for 17 per cent of such deaths globally. The World Health Organisation (WHO) said the major cause of maternal deaths is Post-Partum Haemorrhage (PPH), which is often defined as the loss of more than 500-1,000 ml of blood within the first 24 hours following childbirth. Based on the World Health Statistics (WHS) 2016, the MMR (Maternal Maternity Rate) of India is 174/100,000 live births. Minister of State for Health in a written reply in Indian Parliament, had recently said MMR of India has shown a decline from 212 per 1,00,000 live births in 2007-09 to 167 per 1,00,000 live births in 2011-13, as per the latest report of the Registrar General of India, Sample Registration System (RGI-SRS). India had earlier said its MMR registered a 5.7 per cent decline and, if it continues to fall at this rate, the country will achieve its Millennium Development Goal (MDG) of MMR of 139 per 100,000 live births. Public health, technological and policy approaches are steps that can be taken to drastically reduce the global maternal death. The maternal deaths can be decreased by Improving access to antenatal care in pregnancy, skilled care during childbirth, improved asepsis, fluid management & blood transfusion, and better prenatal care. Most maternal deaths are avoidable, as the health care solutions to prevent or manage complications are well known. Other approaches include avoiding pregnancy at too young of an age or too old of an age and spacing births. Access to primary care for women even before they become pregnant is essential along with access to contraceptives. [ABSTRACT FROM AUTHOR]

Objective: To determine the value of placenta growth factor (PlGF) for predicting hypertensive disorders of pregnancy (HDP) in a low-risk population when used either alone or in combination with other markers.Methods: A prospective observational cohort study was conducted among women with singleton pregnancy in the first trimester in New Delhi, India, between October 1, 2013, and September 30, 2016. First-trimester measures included maternal history, body mass index (BMI), mean arterial pressure (MAP), Doppler uterine artery pulsatility index, and serum levels of biomarkers (including PlGF).Results: Among 1725 women, 208 (12.1%) developed HDP; 74 (35.6%) of these cases were early onset. Mean PlGF levels were significantly lower among cases than among controls (30.42 ± 10.22 vs 37.31 ± 13.28 pg/mL; P<0.001). As a biomarker for prediction of HDP, PlGF fared better than pregnancy-associated plasma protein A (PAPP-A): area under the curve 0.685 (95% confidence interval [CI] 0.620-0.750; P<0.001) versus 0.659 (95% CI 0.593-0.726; P<0.001). The highest odds ratio was found for MAP (8.369, 95% CI 5.752-12.215). The combination of PlGF, PAPP-A, BMI, MAP, and Doppler uterine artery pulsatility index provided an area under the receiver operating characteristic curve of 0.876 (95% CI 0.833-0.919; P<0.001).Conclusion: Combining PlGF concentration with biochemical and biophysical markers provided a good screening test for HDP during the first trimester. [ABSTRACT FROM AUTHOR]

Objective: To assess and compare the ability of serum β-human chorionic gonadotropin (β-hCG) and serum lipid profile in early second trimester as predictors of hypertensive disorders of pregnancy.Methods: The present hospital-based prospective study was conducted between November 24, 2012, and April 30, 2014, at a tertiary hospital in Mangalore, India. Women of any parity with a pregnancy of 14-20 weeks were included. Venous blood (3 mL) was collected, and serum β-hCG and lipid profile were estimated by enzyme-linked immunosorbent assay and an enzymatic colorimetric test with lipid clearing factor, respectively. A cutoff value of β-hCG for predicting hypertensive disorders was obtained by receiver operating curve analysis.Results: Serum β-hCG was significantly higher among women who subsequently developed hypertension (71 142 IU/L [n=27]) than among those who did not (20 541 IU/L [n=137]; P<0.001). The sensitivity and specificity of serum β-hCG to predict hypertension were 92.6% and 94.9% respectively. The positive and negative predictive values were 78.1% and 98.5%, respectively.Conclusion: Serum β-hCG might be used as a predictor of hypertensive disorders that complicate pregnancy. Dyslipidemia was not found to be a useful marker. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The pre-eclampsia is most common hypertensive and life threatening disorder during pregnancy. Abnormal placenta may be involved in the pathogenesis of pre-eclampsia. Co-Enzyme Q10 and trace elements has been proposed as novel factors concerned in development of pre-eclampsia. STUDY DESIGN: Cross sectional, comparative study. SETTING: Study was conducted in Biochemistry department Liaquat University of Medical & Health Sciences Jamshoro and patients were recruited from department of Obstetrics & Gynecology Liaquat University Hospital Jamshoro / Hyderabad. DURATION: 1st February 2015 to 30th October 2015. METHODS: Total 210 volunteers were recruited, from which 50 volunteers were normotensive healthy pregnant women as a control and 160 were pre-eclamptic patients as cases. The subjects were recruited based on sign and symptoms, taking obstetric history, anthropometric, clinical data and collecting blood sample from volunteers. The CoQ10 was evaluated on HPLC while zinc, copper and magnesium on Atomic Absorption Spectrophotometer. RESULTS: The plasma Co-Enzyme Q10 levelwere found decreased in pre-eclamptic patients (mean ±S.D) (0.22±0.09)μg/dl as compared with control group(1.08±0.37) μg/dl with significant difference of p<0.05. Serum zinc, copper and magnesiumlevels in pre-eclampsia were decreased significanlty, it was noted as (2.94±0.44), Cu++ (0.19±0.09) and Mg++(1.16 ± 0.08)mg/dl as compared with normotensive women (5.09±0.29), (0.36± 0.03) and (2.15± 0.09) mg/dl with significant difference of p<0.05 respectively. CONCLUSION: The observation showed that the CoQ10 and trace elements are essential for the healthy pregnancy, declined concentration of CoQ10 and essential trace elements may put forward the possible involvement in the pathology of pre-eclampsia. [ABSTRACT FROM AUTHOR]

Introduction: Pre-eclampsia is a multi-system disorder of pregnancy that is significantly contributes to maternal and fetal morbidity and mortality rates. The aetiology of pre-eclampsia remains unknown. Besides other risk factors, attention has been drawn towards vitamin D deficiency as a causative factor for pre-eclampsia. Aim: To compare vitamin D levels in pre-eclampsia and normotensive pregnant women. Materials and Methods: A prospective comparative study was conducted in the Department of Obstetrics and Gynaecology, Adesh Institute of Medical Sciences and Research (AIMSR), Bathinda, Punjab, India from January 2017 to October 2018. Thirty pregnant women with pre-eclampsia were compared with equal number of normotensive pregnant women for serum vitamin D levels. MS Excel 2010 software was used to analyse the data. Quantitative data were expressed as a mean±standard deviation. Results: It was observed that vitamin D deficiency was invariably present in all pregnant women but the mean vitamin D level was significantly lower in Pre-eclampsia group as compared to Control group (8.7±5.32 and 14.2±7.88 ng/mL respectively) with p<0.05 which was statistically significant. Conclusion: The present study revealed significant association between maternal serum vitamin D deficiency and occurrence of pre-eclampsia. Vitamin D supplements should be added to all the antenatal patients as routine screening to prevent the risk of pre-eclampsia. [ABSTRACT FROM AUTHOR]

Background: In India, the hypertensive disorders of pregnancy and postpartum haemorrhage are responsible for nearly 40 % of all maternal deaths. Most of these deaths occur in primary health settings which frequently lack essential equipment and medication, are understaffed, and have limited or no access to specialist care. Community health care workers are regarded as essential providers of basic maternity care; and the quality of care they provide is dependent on the level of knowledge and skills they possess. However, there is limited research regarding their ability to manage pregnancy complications. This study aims to describe the current state of knowledge regarding pre-eclampsia and eclampsia among community health care workers (auxiliary nurse midwives, accredited social health activists, staff nurses) in northern Karnataka, India. Furthermore, this study describes the treatment approaches used by various cadres of community health workers for these conditions. The findings of this study can help plan focussed training sessions to build upon their strengths and to address the identified gaps. Methods: Data were collected as part of a larger study aimed at assessing the feasibility of community-based treatment for pre-eclampsia. Eight focus group discussions were conducted in 2012-2013 in northern Karnataka State: four with staff nurses and auxiliary nurse midwives and four with accredited social health activists. In addition, twelve auxiliary nurse midwives and staff nurses completed questionnaires to explore their competence and self-efficacy in managing pre-eclampsia. Qualitative data were audio-recorded, transcribed verbatim and translated for thematic analysis using NVivo 10. Results: Community health workers described their understanding of the origins of hypertension and seizures in pregnancy. Psychological explanations of hypertension were most commonly reported: stress, tension, and fear. The most common explanation for eclampsia was not receiving a tetanus vaccination. Despite some common misperceptions regarding aetiology, these community health workers demonstrated a good grasp of the potential consequences of hypertension in pregnancy. According to auxiliary nurse midwives and staff nurses, if hypertension was detected they encouraged rest, decreased salt intake, iron supplementation and tetanus vaccination. In addition, some staff nurses administered antihypertensives, MgSO4, or other anticonvulsants. All auxiliary nurse midwives had some awareness of MgSO4, but none had administered it themselves. Conclusions: This study showed that knowledge regarding the aetiology of pre-eclampsia was limited. Nevertheless, their basic knowledge and skills could be strengthened to more effectively manage the hypertensive disorders of pregnancy in their communities. [ABSTRACT FROM AUTHOR]

Background: Maternal deaths have been attributed in large part to delays in recognition of illness, timely transport to facility, and timely treatment once there. As community perceptions of pregnancy and their complications are critical to averting maternal morbidity and mortality, this study sought to contribute to the literature and explore community-based understandings of pre-eclampsia and eclampsia. Methods: The study was conducted in rural Karnataka State, India, in 2012-2013. Fourteen focus groups were held with the following community stakeholders: three with community leaders (n = 27), two with male decision-makers (n = 19), three with female decision-makers (n = 41), and six with reproductive age women (n = 132). Focus groups were facilitated by local researchers with clinical and research expertise. Discussions were audio-recorded, transcribed verbatim and translated to English for thematic analysis using NVivo 10. Results: Terminology exists in the local language (Kannada) to describe convulsions and hypertension, but there were no terms that are specific to pregnancy. Community participants perceived stress, tension and poor diet to be precipitants of hypertension in pregnancy. Seizures in pregnancy were thought to be brought on by anaemia, poor medical adherence, lack of tetanus toxoid immunization, and exposure in pregnancy to fire or water. Sweating, fatigue, dizziness-unsteadiness, swelling, and irritability were perceived to be signs of hypertension, which was recognized to have the potential to lead to eclampsia or death. Home remedies, such as providing the smell of onion, placing an iron object in the hands, or squeezing the fingers and toes, were all used regularly to treat seizures prior to accessing facility-based care although transport is not delayed. Conclusions: It is evident that 'pre-eclampsia' and 'eclampsia' are not well-known; instead hypertension and seizures are perceived as conditions that may occur during or outside pregnancy. Improving community knowledge about, and modifying attitudes towards, hypertension in pregnancy and its complications (including eclampsia) has the potential to address community-based delays in disease recognition and delays in treatment that contribute to maternal and perinatal morbidity and mortality. Advocacy and educational initiatives should be designed to target knowledge gaps and potentially harmful practices, and respond to cultural understandings of disease. [ABSTRACT FROM AUTHOR]

Background: Globally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude. Methods: A mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance. Results: Refer to CLIP Trial feasibility publications in the current and/or forthcoming supplement. Conclusions: Feasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts. [ABSTRACT FROM AUTHOR]

Objective: To assess the accuracy of angiogenic biomarkers to predict pre-eclampsia.Design: Prospective multicentre study. From 2006 to 2009, 5121 pregnant women with risk factors for pre-eclampsia (nulliparity, diabetes, previous pre-eclampsia, chronic hypertension) from Argentina, Colombia, Peru, India, Italy, Kenya, Switzerland and Thailand had their serum tested for sFlt-1, PlGF and sEng levels and their urine for PlGF levels at ⩽20, 23-27 and 32-35weeks' gestation (index tests, results blinded from carers). Women were monitored for signs of pre-eclampsia, diagnosed by systolic blood pressure ⩾140mmHg and/or diastolic blood pressure ⩾90mmHg, and proteinuria (protein/creatinine ratio ⩾0.3, protein ⩾1g/l, or one dipstick measurement ⩾2+) appearing after 20weeks' gestation. Early pre-eclampsia was defined when these signs appeared ⩽34weeks' gestation.Main Outcome Measure: Pre-eclampsia.Results: Pre-eclampsia was diagnosed in 198 of 5121 women tested (3.9%) of whom 47 (0.9%) developed it early. The median maternal serum concentrations of index tests were significantly altered in women who subsequently developed pre-eclampsia than in those who did not. However, the area under receiver operating characteristics curve at ⩽20weeks' gestation were closer to 0.5 than to 1.0 for all biomarkers both for predicting any pre-eclampsia or at ⩽34weeks' gestation. The corresponding sensitivity, specificity and likelihood ratios were poor. Multivariable models combining sEng with clinical features slightly improved the prediction capability.Conclusions: Angiogenic biomarkers in first half of pregnancy do not perform well enough in predicting the later development of pre-eclampsia. [ABSTRACT FROM AUTHOR]

Aim The aim of our study was to examine the association of low pregnancy-associated plasma protein- A ( PAPP-A) with adverse pregnancy outcome. Material and Methods A total of 1640 consecutive pregnant women between 9+5 and 13+6 weeks of pregnancy were recruited. One hundred and thirty women with PAPP-A levels < 0.4 multiple of median were followed till delivery and the outcome information was obtained for fetal loss, birthweight, growth restriction, preterm birth, reduced liquor and development of pre-eclampsia. Results During the study period, 130 (7.92%) women had low PAPP-A and were considered as cases and 200 women with normal PAPP-A were controls. Intrauterine growth restriction was observed in 28 (21.54%) cases as compared to 10 (5%) controls. Pre-eclampsia presented in 24 (18.46%) cases and in 18 (9%) controls. Twenty (15.38%) cases had preterm delivery compared to 12 (6%) controls. Fifty-six (43.08%) cases delivered low-birthweight babies compared to 22 (11%) controls. Thus, the incidence of intrauterine growth restriction, preterm birth and low birthweight was significantly more in the cases as compared to the control group. Conclusions PAPP-A is a valuable analyte for predicting risk of adverse pregnancy outcome and women with low serum PAPP-A levels would benefit from closer surveillance. [ABSTRACT FROM AUTHOR]

A study to assess the effectiveness of planned teaching programme on pre-eclampsia for primigravida women in a selected commmunity at Mangalore was undertaken with 30 samples. The research approach was pre-experimental approach with one group pre-test post-test design. Purposive sampling technique was used to select the samples. The study findings revealed that in the pre-test knowledge assessment the mean percentage of response was (32.23%) and in the post-test the mean percentage was (84.9%). Furthur effectivess of planned teaching programme was tested by inferential statistics using paired "t" test. A very significant (P< 0.001) difference was found between pre-test and post-test knowledge scores of the respondents indicating an increase in knowledge after planned teaching programme. Thus, planned teaching programme was found to be effective in improving the knowledge of primigravida women regarding pre-eclampsia. [ABSTRACT FROM AUTHOR]

Background: In India, more than 60% of hospital beds are in private facilities, yet several studies have observed suboptimal quality of care in private facilities. We aimed to understand the role of Manyata, a quality improvement initiative in private facilities focused on mentorship and clinical standards, to improve the knowledge and skills of health care providers, their adherence to key childbirth-related clinical practices, and health outcomes for women and newborns., Methods: We conducted a secondary analysis of Manyata program data collected from 466 private facilities across 3 states (Jharkhand, Maharashtra, and Uttar Pradesh) in India from October 2016 to February 2019. We calculated means and 95% confidence intervals for knowledge and skills assessment, adherence to facility standards was analyzed by calculating the proportion of facilities passing a given quality standard at baseline and endline, and changes in pregnancy outcomes were assessed with autoregression modeling., Results: From assessments conducted before and after training among providers in Manyata, we observed a significant increase in average knowledge score (6.3 vs. 13.2 of 20) and skill score (8.0 vs. 34.3 of 40). Overall, a significant increase occurred in adherence to clinical standards between baseline and endline assessments (29% vs. 93%). The standards with the greatest improvements were identification and management of eclampsia/preeclampsia, postpartum hemorrhage, and neonatal resuscitation. There were no significant changes over time in absolute rate of reported complications; however, referral rates from private facilities for preeclampsia and newborn sepsis identification and management declined., Conclusion: Our analysis indicates private facilities' adherence to quality standards and nurses' childbirth knowledge and practical skills increased during Manyata. Additional efforts are needed to ensure high-quality care during cesarean deliveries at private facilities. Future studies with rigorous design are required to evaluate the impact of this quality improvement initiative in improving pregnancy outcomes., (© Marx Delaney et al.)

Background: Pre-eclampsia is one of the major causes of maternal and fetal morbidity and mortality. Though the aetiology is obscure, recent studies indicate that serum levels of calcium and magnesium may have a role in pre-eclampsia. Aim: The aim of this study was to find out the relationship of serum levels of calcium and magnesium in pre-eclamptic pregnancies compared to normal pregnancies in women from southern coastal India. Settings and Design: This study was done in a medical college hospital in southern coastal India. Materials and Methods: The blood samples from 60 pre-eclamptic women and an equal number of controls were analysed for calcium and magnesium levels. Data on Body Mass Index, maternal and gestational ages, serum calcium and magnesium were compared between the two groups. Outcome of pregnancy was analysed in both the groups and compared. Statistical Analysis: Data was expressed as Mean ± Standard Deviation. Data analysis was done by SPSS version 20. Comparison of serum levels of the elements between the two groups was performed by Independent t-test and Chi-square test and P-value of < 0.05 was considered as statistically significant. Results: The serum calcium concentration was significantly lower in the pre-eclamptic group compared to normotensives (7.84 ± 0.87 mg/dl Vs 8.97± 0.69 mg/dl, p<0.001) whereas the levels of serum magnesium showed a marginal difference in both the groups. (1.43± 0.55 mg/dl Vs, 1.57 ± 0.72 mg/dl P 0.257) The study also showed that pre-eclamptic women were older, their BMI was higher and birth weight of babies lower compared to normotensives. Conclusion: According to the results of our research, intake of supplements, mainly calcium may help in the reduction of incidence of pre-eclampsia especially in a population of a developing country like ours where the nutrition is poor. Not many studies have been done in developing countries to assess the role of these elements in pre-eclampsia. The actual role of magnesium and calcium supplements needs further investigation. [ABSTRACT FROM AUTHOR]

Aim The present study was designed to find any association of cytokines in women with periodontal disease and development of pre-eclampsia in North Indian population. Materials and Methods A total of 504 consecutively registered primigravida with a single live pregnancy were recruited at 14-18 weeks of gestation from antenatal clinic of Maulana Azad Medical College & associated Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences, New Delhi. One periodontist performed oral health examination of all patients at inclusion into study. Blood samples were collected to measure the level of cytokines IL-4, IL-10, TNF-α and IFN-γ. Results The profile of blood levels of cytokines from women with periodontal disease was observed. The log serum levels of TNF-α & IL-4 at 16-18 weeks of gestation were significantly higher in women with periodontal disease (4.13 ± 2.06; 0.47 ± 1.56 pg/ml respectively) than in women with healthy gums (2.16 ± 1.51; 0.02 ± 1.84 pg/ml respectively, p < 0.001). Periodontal disease is associated with log serum TNF-α levels at cut-off ≥14.43 pg/ml at sensitivity 71.2% and specificity 62% ( OR = 4.04; 95% CI = 2.77-5.87). Woman with periodontal disease who later developed pre-eclampsia had lower levels of TNF-α (3.72 ± 1.33 pg/ml) than those with periodontal disease who did not develop pre-eclampsia (4.20 ± 2.15 pg/ml, p ≥ 0.05). Conclusion Reduced TNF-α level secretion in the early second trimester in women with periodontal disease appears to be associated with the development of pre-eclampsia. [ABSTRACT FROM AUTHOR]

Background: Stress has been said to be the underlying cause in the etiopathogenesis of the diseases like Bronchial asthma, Peptic ulcer, Essential hypertension and Toxemia of pregnancy. The identification of pre eclampsia and its effective management plays a significant role in the outcome of pregnancy both for the mother and the baby. Yogic exercises have been reported to be beneficial in stress related disorders by producing calming effect on nervous system. Aims & Objective: The aim of present study was to explore the possibility of the use of Bhramari Pranayama as a preventive measure of pre eclampsia. Materials and Methods: Fifty pregnant women in the age group of 20 to 28 years were included in the present study. The cardio vascular reactivity of these subjects was studied by application of the cold pressor test. Initially there were 28 hyper reactors to this test. These hyper reactors underwent Bhramari Pranayama for the duration of 2 months. It was observed that the hyper- reactivity of 22 subjects was converted to hypo- reactivity whereas the remaining 6 subjects did not alter their response. Results: Regular practice of Bhramari Pranayama reduced the cardio vascular hyper- reactivity to cold stress after just 8 weeks. Conclusion: The hyper- reactivity to cold stress may be an early indication of the developing pre eclampsia. Conversion of this response to hypo -reactivity may be used as a tool for prevention of pregnancy induced hyper tension. [ABSTRACT FROM AUTHOR]

Objective To compare magnesium sulphate concentrations achieved by intramuscular and intravenous regimens used for the prevention of eclampsia. Setting Low-resource obstetric hospitals in Nagpur and Vellore, India. Population Pregnant women at risk for eclampsia due to hypertensive disease. Methods A pharmacokinetic study was performed as part of a randomised trial that enrolled 300 women comparing intramuscular and intravenous maintenance regimens of magnesium dosing. Data from 258 enrolled women were analysed in the pharmacokinetic study. A single sample was drawn per woman with the expectation of using samples in a pooled data analysis. Main outcome measures Pharmacokinetic parameters of magnesium distribution and clearance. Results Magnesium clearance was estimated to be 48.1 dl/hour, volume of distribution to be 156 dl and intramuscular bioavailability to be 86.2%. The intramuscular regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, magnesium concentrations in the intramuscular and intravenous groups were comparable. With either regimen, a substantial number of women would be expected to have serum concentrations lower than those generally held to be therapeutic. Conclusions Clinical implications were that a larger loading dose for the intravenous regimen should be considered; where feasible, individualised dosing of magnesium sulphate would reduce the variability in serum concentrations and might result in more women with clinically effective magnesium concentrations; and lower dose magnesium suphate regimens should be considered with caution. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate microalbuminuria at mid-pregnancy, using the albumin-to-creatinine ratio (ACR), as a predictor of pre-eclampsia. Material and Methods: This prospective observational study was carried out on 144 normotensive women, aged < 35 years, body mass index < 25 kg/m2, and live singleton pregnancy between 24 and 28 weeks. In all, the ACR was measured in spot random urine samples. Normoalbuminuria was an ACR of <30 mg/g, whereas microalbuminuria was an ACR of 30-299 mg/g creatinine. All were followed till delivery. Primary outcome was the development of pre-eclampsia. The secondary outcome measures were preterm births and neonatal birthweight. Statistical analysis was done with Fisher's exact and t-tests. Results: Of all, 77.1% (111/144) had normoalbuminuria and 22.9% (33/144) had microalbuminuria. Of 33 microalbuminuric women, the mean blood pressure was significantly higher in those who subsequently developed pre-eclampsia ( P < 0.001). The mean ACR (mg/g) in this cohort was 60.6 ± 29.4. The mean ACR (mg/g) in women who subsequently developed pre-eclampsia was significantly higher than in women who remained normotensive ( P = 0.003). Of 33 microalbuminuric women, 12 (36.4%) developed pre-eclampsia, and eight (24.2%) had preterm births. The mean birthweight (kg ± standard deviation) was significantly lower in the microalbuminuria group (2.45 ± 0.6) as compared to the normoalbuminuria group (2.8 ± 0.37), P < 0.001. Conclusion: Microalbuminuria in mid-pregnancy may be a significant predictor of development of subsequent pre-eclampsia, preterm birth and low-birthweight babies. [ABSTRACT FROM AUTHOR]

Aim: The present study aims to determine the association of periodontal disease (identified early in pregnancy) and adverse pregnancy outcomes in a North Indian population. Material and Methods: A total of 340 primigravida women, aged 20-35 years with single live pregnancy were recruited at 14-20 weeks period of gestation from the antenatal clinic. These women had undergone periodontal examination at time of recruitment. The pregnancy outcomes were recorded. Results: Out of 340 primigravida women, 147 (43.23%) women had gingivitis and 61 (17.94%) women had periodontitis. Periodontitis was found to be significantly associated with pre-eclampsia, intrauterine growth restriction, preterm delivery, and low birthweight with odds ratios (95% confidence interval) of 7.48 (2.72-22.42), 3.35 (1.20-9.55), 2.72 (1.30-5.68) and 3.03 (1.53-5.97), respectively. Conclusions: The study shows a significant association between periodontitis (but not with gingivitis) and adverse pregnancy outcomes. Maternal periodontitis is associated with an increased risk of pre-eclampsia, intrauterine growth restriction, preterm delivery and low birthweight infants. [ABSTRACT FROM AUTHOR]

Background: South Asia contributes more than a third of all global stillbirths, yet the causes remain largely unstudied in this region. New investigations, including novel assessments of placental and fetal tissues, facilitate more precise determination of the underlying causes of stillbirth. We sought to assess underlying and contributing causes of stillbirth from settings in India and Pakistan., Methods: In this prospective cohort study (PURPOSe), we report the cause of death in stillbirths in hospitals in central India and south Pakistan (Davangere, India [three public and private hospitals] and Karachi, Pakistan [one public maternity and one children's hospital]). Women aged 15 years or older and with a known stillbirth (defined as a pregnancy at 20 or more weeks of gestation with the in-utero death of a fetus) weighing 1000 g or more were included in the study. Maternal clinical factors, placental evaluation, fetal tissue evaluation (from minimally invasive tissue sampling), and PCR for microbial pathogens were used to identify the causes of death. An expert panel reviewed available data for all stillbirths to identify the primary and contributing maternal, placental, and fetal causes of stillbirth., Findings: Between Sept 1, 2018, and Feb 12, 2020, 981 stillborns were included and, of those, 611 were reviewed by the expert panel. The primary maternal causes of stillbirth were hypertensive disease in 221 (36%) of 611 stillbirths, followed by severe anaemia in 66 (11%) stillbirths. The primary placental causes were maternal and fetal vascular malperfusion, in 289 (47%) stillbirths. The primary fetal cause of stillbirth was intrauterine hypoxia, in 437 (72%) stillbirths. We assessed the overlap of main causes and 116 (19%) stillbirths had intrauterine hypoxia, placental malperfusion, and eclampsia or pre-eclampsia indicated as primary causes of death. Infection (including of the placenta, its membranes, and in the fetus) and congenital anomalies also were causative of stillbirth., Interpretation: In south Asia, fetal asphyxia is the major cause of stillbirth. Several placental lesions, especially those associated with maternal and fetal vascular malperfusion and placental abruption, have an important role in asphyxia and fetal death. Maternal hypertension, and especially pre-eclampsia, is often the primary maternal condition associated with this pathway., Funding: Bill & Melinda Gates Foundation., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objective: To identify factors at the health facility and health professional levels that might hinder or facilitate the appropriate use of magnesium sulfate for the treatment of pre-eclampsia and eclampsia.Methods: Seven focus group discussions were conducted with a purposively sampled group of obstetricians/gynecologists, medical residents, and nurses at 3 hospitals in Nagpur, India. Data were collected on facility and drug availability, criteria for diagnosis and management of pre-eclampsia and eclampsia, attitudes about magnesium sulfate use, and perceived barriers to the treatment of pre-eclampsia and eclampsia.Results: Senior gynecologists seemed to encourage the use of magnesium sulfate, especially management prior to transfer to a higher facility. However, clinicians noted a lack of specific institutional guidelines on dose, timing, and indications, particularly in cases in which delivery was not imminent. In all facilities, service providers noted that their clinical care decisions were sometimes influenced by political and social factors, making management of eclampsia and pre-eclampsia cases difficult. Care was further challenged by limited drug availability, particularly at the tertiary-care center.Conclusion: Limited drug supply and lack of specific institutional guidelines, equipment, and trained staff hinder the translation of evidence-based policy on magnesium sulfate into practice. [ABSTRACT FROM AUTHOR]

Objective: The objective was to study the determinants of pre-eclampsia among pregnant women admitted for delivery in a district hospital. Materials and Methods: A case--control study was conducted at District Lady Goschen Hospital, Dakshina Kannada district, Karnataka, South India. The group of pregnant women with pre-eclampsia comprised those with hypertension after the 20th week of gestation with associated proteinuria, and controls were pregnant women not diagnosed with pre-eclampsia. A total of 100 cases and 100 controls were selected for the year 2006. Study variables included mother's age, parity, body mass index, history of chronic hypertension, history of diabetes, history of renal disease, family history of hypertension, and history of pre-eclampsia in earlier pregnancy. Statistical Analysis: Chi-square test, and crude and adjusted odds ratio with 95% confidence intervals were used for statistical analysis. Results: Significant risk factors identified in univariate analysis included prepregnancy body mass index (BMI = 25) (OR = 11.27), history of chronic hypertension (OR = 8.65), history of diabetes (OR = 11.0), history of renal disease (OR = 7.98), family history of hypertension (OR = 5.4), history of pre-eclampsia in earlier pregnancy (OR = 9.63), and multiple pregnancy (OR = 4.85). Multiple logistic regression analysis revealed that the prepregnancy BMI of >25 (OR = 7.56), history of chronic hypertension (OR = 6.69), history of diabetes (OR = 8.66), history of renal disease (OR = 5.6), family history of hypertension (OR = 5.48), and multiple pregnancy (OR = 5.73) are the significant risk factors of pre-eclampsia. Conclusion: Pregnant women at risk of pre-eclampsia should be identified and high-quality antenatal care should be given in order to minimize the complications of pre-eclampsia both for the mother and the fetus. [ABSTRACT FROM AUTHOR]

Studies from high-income countries report associations of preeclampsia (PE) with reduced cognitive function and adverse behavioural outcomes in children. We examined these associations in Indian children aged 5-7 years. Children of mothers with PE (n=74) and without PE (non-PE; n=234) were recruited at delivery at Bharati Hospital, Pune, India. The cognitive performance was assessed using 3 core tests from the Kaufman Assessment Battery and additional tests including Verbal fluency, Kohs block design, and Coding A (from Wechsler Intelligence Scale for Children). The parent-reported Strengths and Difficulties Questionnaire (SDQ) was used to assess children's behavioral characteristics. Scores were compared between children from PE and non-PE groups, and associations analyzed further using regression models, adjusted for potential confounders. After adjusting for age, sex, socio-economic status and maternal education, children of PE mothers had lower Kohs block design scores (adjusted odds ratio per score category 0.57, [95% CI 0.34-0.96] p=0.034; 0.62 [95%CI (0.36, 1.07), p=0.09 on further adjustment for birth weight and gestation) compared to children of mothers without PE. In the SDQ, there was a lower prevalence of abnormal 'conduct problem' scores in PE group than non-PE group (OR=0.33, 95% CI 0.13-0.83, p=0.018, in the fully adjusted model); there were no differences for other behavioral domains. This preliminary study in Indian children suggests that fetal exposure to maternal PE may have an adverse impact on visuo-spatial performance but does not adversely affect behavior. Further studies with larger sample sizes are essential to understand effects of maternal PE on cognitive/behavioral outcomes in children.

Background: Pregnancy is a metabolic state which demands increased iron bioavailability. While in preeclampsia, due to the placental vascular events there is an iron surplus environment along with inflammation and placental hypoxia. Routinely in India iron is supplemented to all pregnant women irrespective of their general physical condition. Hepcidin a regulator of iron metabolism protects the cells from iron mediated cytotoxicity., Objective: To find out whether hepcidin gets induced as a protective mechanism in preeclampsia patients in order to combat the environment of iron overload, oxidative stress, and endothelial dysfunction., Methods: A cross-sectional study with follow up was carried out in a South Indian Tamil population. Forty healthy pregnant women and forty preeclampsia patients in the gestational age 32 ± 4 weeks were recruited ( n  = 80). Biochemical analysis to assess the serum levels of the following were carried out (1) indices of iron homeostasis - serum iron, ferritin, transferrin, hepcidin, (2) endothelial dysfunction -serum assymetric dimethyl arginine (ADMA) (3) oxidative stress - Malon di aldehyde (MDA) and ferric reducing ability of plasma (FRAP). Kolmogorov-Smirnov test, Mann-Whitney U test, Spearman's correlation, linear regression and ROC AUC analysis were performed to understand their relationship with each other., Results: Levels of serum iron, ferritin, transferrin saturation, hepcidin, and MDA/FRAP ratio were elevated significantly in preeclampsia patients compared to controls, while serum transferrin levels were significantly decreased in them. Hepcidin levels showed a significant positive correlation with serum ADMA, and MDA/FRAP. Serum hepcidin, transferrin saturationand MDA/FRAP ratio is useful in differentiating pre-eclampsia patients from healthy pregnant women., Conclusion: Iron supplementation in preeclampsia patients might have led to a state of iron overload, which might have caused oxidative stress and endothelial dysfunction in preeclampsia patients. The rise in hepcidin levels in this scenario may be viewed as a protective mechanism to combat the iron overload mediated cytotoxicity.

Background: To evaluate the performance of the Fetal Medicine Foundation (FMF) preterm preeclampsia (PE) screening algorithm in an indigenous South Asian population., Methods: This was a prospective observational cohort study conducted in a tertiary maternal fetal unit in Delhi, India over 2 years. The study population comprised of 1863 women carrying a singleton pregnancy and of South Asian ethnicity who were screened for preterm pre-eclampsia (PE) between 11 and 14 weeks of gestation using Mean Arterial Pressure (MAP), transvaginal Mean Uterine Artery Pulsatility Index (UtAPI) and biochemical markers - Pregnancy Associated Plasma Protein-A (PAPP-A) and Placental Growth Factor.. Absolutemeasurements of noted biomarkers were converted to multiples of the expected gestational median (MoMS) which were then used to estimate risk for preterm PE < 37 weeks using Astraia software. Women with preterm PE risk of ≥1:100 was classified as as high risk. Detection rates (DR) at 10% false positive rate were calculated after adjusting for prophylactic aspirin use (either 75 or 150 mg)., Results: The incidence of PE and preterm PE were 3.17% (59/1863) and 1.34% (25/1863) respectively. PAPP-A and PlGF MoM distribution medians were 0.86 and 0.87 MoM and significantly deviated from 1 MoM. 431 (23.1%) women had a risk of ≥1:100, 75 (17.8%) of who received aspirin. Unadjusted DR using ≥1:100 threshold was 76%.Estimated DRs for a fixed 10% FPR ranged from 52.5 to 80% depending on biomarker combination after recentering MoMs and adjusting for aspirin use., Conclusion: The FMF algorithm whilst performing satisfactorily could still be further improved to ensure that biophysical and biochemical markers are correctly adjusted for indigenous South Asian women., (© 2021. The Author(s).)

Background: Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organization currently recommends that pregnant women receive high-dose calcium supplementation (1500-2000 mg elemental calcium) for prevention of preeclampsia in populations with low dietary calcium intake. Trials of low-dose calcium supplementation (< 1000 mg elemental calcium/day) during pregnancy have also shown similar reductions in the risk of preeclampsia; however, no trials to date have directly compared low-dose to the standard high-dose calcium supplementation. Our objective is to assess the non-inferiority of low-dose as compared to standard high-dose calcium supplementation in pregnancy., Methods/design: We will conduct two independent trials in Bangalore, India (n = 11,000 pregnancies), and Dar es Salaam, Tanzania (n = 11,000 pregnancies). The trial designs are individually randomized, parallel group, quadruple-blind, non-inferiority trials of low-dose calcium supplementation (500 mg elemental calcium/day) as compared to standard high-dose calcium supplementation (1500 mg elemental calcium/day) among nulliparous pregnant women. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized calcium regimen from randomization until the time of delivery. The co-primary outcomes are (i) preeclampsia and (ii) preterm birth; we will test non-inferiority of the primary outcomes for low-dose as compared to the standard high-dose supplementation regimen in each trial. The trials' secondary outcomes include gestational hypertension, severe features of preeclampsia, pregnancy-related death, third trimester severe anemia, fetal death, stillbirth, low birthweight, small-for-gestational age birth, and infant death., Discussion: The trials will provide causal evidence on the non-inferiority of low-dose as compared to the standard high-dose supplementation in India and Tanzania. A single tablet, low-dose calcium supplementation regimen may improve individual-level adherence, reduce programmatic costs, and ultimately expand implementation of routine calcium supplementation in pregnancy in populations with low dietary calcium intake., Trial Registration: ClinicalTrials.gov identifier: NCT03350516 ; registered on 22 November 2018. Clinical Trials Registry-India identifier: CTRI/2018/02/012119 ; registered on 23 February 2018. Tanzania Medicines and Medical Devices Authority Trials Registry identifier: TFDA0018/CTR/0010/5 ; registered on 20 December 2018., (© 2021. The Author(s).)

Background: Every year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared., Methods: This pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women's experience are also planned., Discussion: Avoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman's care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin., Trial Registration: Clinical Trials.gov, NCT03749902 , registered on 21 st Nov 2018., (© 2021. The Author(s).)