Standardization of Anti-Xa Assay and its Comparison with Activated Partial Thromboplastin Time for Monitoring Unfractionated Heparin Therapy.

Monitoring of anticoagulant activity of unfractionated heparin (UFH) is primarily done with activated partial thromboplastin time (aPTT), which is affected by many factors. Anti-Xa assays are considered to overcome these factors and may provide a better method for monitoring patients on UFH with a narrow therapeutic range. This study aimed to compare the effectiveness of aPTT and anti-Xa assays in UFH monitoring. A prospective non-randomized study was carried out in two stages: first, the anti-Xa assay was standardized using kit instructions; each sample was then analyzed by both tests. The outcomes of the two assays were compared and assessed for agreement of maintaining therapeutic anticoagulant levels. These levels for anti-Xa assay were between 0.3 and 0.7 IU/ml, while it was 1.5-2.5 times the control for aPTT assay. Below this range was regarded as subtherapeutic, and above this as supratherapeutic. A total of 90 samples were tested and analyzed using both assays. Most of them (> 70%) were noted to be in subtherapeutic levels with both tests. The overall concordance was 73.3%, and the estimated kappa value was 0.483 (0.396-0.57). The correlation between aPTT and anti-Xa assay was 0.74 (p < 0.001). With anti-Xa levels in the therapeutic range, aPTT levels were in subtherapeutic in 60% and supratherapeutic in 13.3% cases. Although both the testing strategies had a good agreement and correlation, discordance was observed in interpretative values with anti-Xa levels in therapeutic range and aPTT levels in non-therapeutic range. Its clinical implications need to be evaluated further in future studies.

Impact of social determinants of health on progression from potentially life-threatening complications to near miss events and death during pregnancy and post partum in a middle-income setting: an observational study.

OBJECTIVE: To assess the potential associations between social determinants of health (SDH) and severe maternal outcomes (SMO), to better understand the social structural framework and the contributory, non-clinical mechanisms associated with SMO. STUDY DESIGN: Prospective observational study. STUDY SETTING: Tertiary referral centre in south-eastern region of India. PARTICIPANTS: One thousand and thirty-three women with potentially life-threatening complications (PLTC) were identified using WHO criteria. RISK FACTORS ASSESSED: Social Determinants of Health (SDH). PRIMARY OUTCOMES: Severe maternal outcomes, which include maternal near-miss and maternal death. STATISTICAL ANALYSIS: Logistic regression to assess the association between SDH and clinical factors on SMO, expressed as adjusted ORs (aOR) with a 95% CI. RESULTS: Of the 37 590 live births, 1833 (4.9%) sustained PLTC, and 380 (20.7%) developed SMO. Risk of SMO was higher with increasing maternal age (adjusted OR (aOR) 1.04 (95% CI 1.01 to 1.07)), multiparity (aOR 1.44 (1.10 to 1.90)), medical comorbidities (aOR 1.50 (1.11 to 2.02)), obstetric haemorrhage (aOR 4.63 (3.10 to 6.91)), infection (aOR 2.93 (1.83 to 4.70)), delays in seeking care (aOR 3.30 (2.08 to 5.23)), and admissions following a referral (aOR 2.95 (2.21 to 3.93)). SMO was lower in patients from socially backward community (aOR 0.45 (0.33 to 0.61)), those staying more than 10 km from hospital (aOR 0.56 (0.36 to 0.78)), those attending at least four antenatal visits (aOR=0.53 (0.36 to 0.78)) and those referred from resource-limited facilities (aOR=0.62 (0.46 to 0.84)). CONCLUSION: This study demonstrates the independent contribution of SDH to SMO among those sustaining PLTC in a middle-income setting, highlighting the need to formulate preventive strategies beyond clinical considerations.

Comparing the outcomes of rheumatic heart disease in pregnancy complicated with and without atrial fibrillation: A propensity score matched analysis.

BACKGROUND: Atrial fibrillation (AF) may increase the risk of adverse maternal and fetal outcomes among pregnant with rheumatic valvular lesions (RHD). We aimed to assess the rate of occurrence of AF in pregnant with RHD and its impact on cardiac and maternal-fetal outcomes compared to those without it. METHODS: The study group consisted of pregnant women with RHD and AF (cases) and a matched comparison group of pregnant women with RHD but without AF (controls) was derived from the database of pregnant women with RHD receiving care at our center between 2011 and 2021. Incidence of composite adverse outcomes(maternal death, heart failure, or thrombo-embolic events) and pregnancy outcomes were compared between them. RESULTS: Seventy-one (5.1%; 95%CI 4.1%-6.4%) pregnant women with RHD had AF during pregnancy and childbirth, most occurring in the late second or early third trimester. New-onset AF was diagnosed in 34 (47.9%) of them. After matching, the incidence of composite outcome was higher in women with AF (77.5% (95%CI 66.3%-85.7%) compared to women without AF (17.3%(95%CI 13.3%-22.1%), P < .001), with seven (9.9%) maternal deaths among cases and two (0.7%) in controls. Heart failure was the most common adverse cardiac event (26.7% vs. 4.2%, P < .001, cases vs controls). Those with AF had higher odds (adjusted OR 56.6 (14.1-226.8)) of adverse cardiac outcomes after adjusting for other risk factors. The frequency of most non-cardiac pregnancy complications was similar in both groups. However, there was a trend towards a higher rate of miscarriage (16.9% vs. 9.9%), small-for-gestational-age babies(16.3 vs. 9.0%), and cesarean rates(31.9% vs. 18.3%) women with AF compared to those who did not experience AF. CONCLUSIONS: Atrial fibrillation in pregnancy among women with RHD was associated with an increased risk of maternal morbidity and mortality, with a trend towards an increase in some non-cardiac pregnancy complications compared to those pregnant women without AF. Our study results provide background data for developing and implementing a pregnancy-specific management strategy tailored to middle-income settings.

Impact of near-miss event during pregnancy and childbirth on maternal health at 12 months.

OBJECTIVE: To assess the impact of maternal near-miss on late maternal death and the prevalence of hypertension or chronic kidney disease (CKD) and mental health problems at 12 months of follow up. METHODS: This prospective cohort study was conducted in a tertiary hospital in the southeastern region of India from May 2018 to August 2019, enrolling those with maternal near-miss and with follow up for 12 months. The primary outcomes were incidence of late maternal deaths and prevalence of hypertension and CKD during follow up. RESULTS: Incidence of maternal near miss was 6.7 per 1000 live births. Among those who had a near miss, late maternal deaths occurred in 7.2% (95% confidence interval [CI] 3.1%-11.3%); prevalence of CKD was 23.0% (95% CI 16.2%-29.8%), and of hypertension was 56.2% (95% CI 50.5%-66.5%) and only two women had depression on follow up. After adjusting for age, parity, socioeconomic status, gestational age at delivery, hemoglobin levels, and perinatal loss, only serum creatinine was independently associated with late maternal death and CKD on follow up. CONCLUSIONS: Women who survive a life-threatening complication during pregnancy and childbirth are at increased risk of mortality and one or more long-term sequelae contributing to the non-communicable disease burden. A policy shift to increase postpartum follow-up duration, following a high-risk targeted approach after a near-miss event, is needed.

External validation of prediction models for vaginal delivery after the trial of labour among women with previous one caesarean section - A cohort study.

OBJECTIVE: To externally validate three predictive models (the Grobman model (2007), the Zhang model (2020), and the Grobman model (2021)) for identifying women with increased chances of a successful trial of labour after caesarean section (TOLAC). METHODS: This retrospective observational cohort study was conducted in a tertiary teaching hospital from 2018 to 2021. Individual probabilities were calculated for women with previous one caesarean section who underwent TOLAC at term, using the predicted probabilities from the logistic regression models. The primary outcome of this study was vaginal delivery following attempted TOLAC. The predictive ability of the models was assessed using the area under the receiver operative characteristics curves (AUC) and a calibration graph. RESULTS: Of 1515 eligible women who underwent TOLAC, we found an overall rate of successful TOLAC of 60.3 %. No significant difference was noticed in adverse scar outcome and neonatal morbidity while comparing successful and failed TOLAC. The discriminative ability of Grobman-2007 and Grobman-2021 and the Zhang model were fair to poor with the AUC of 0.54(95 % CI 0.51-0.57), 0.62(95 % CI 0.59-0.65) and 0.66(95 % CI 0.63-0.69) respectively. The agreement between the observed rates of TOLAC success and the predicted probabilities for all three models was poor. CONCLUSION: The performance of all three models predicting success after TOLAC was poor in the study population. A population-specific model may be needed, with the addition of factors influencing the labour, such as the methods of induction, which may aid in predicting the outcome.

Association of plasma Decorin levels and markers of glycocalyx disruption with adverse events in women with severe preeclampsia.

Identifying preeclamptic women with an increased risk of severe maternal complications can aid in timely interventions to optimize pregnancy outcomes. Newer biomarkers such as Decorin and markers of endo glycocalyx disruption were assessed in earlier studies for its role in predicting preeclampsia, but their role in identifying those with adverse maternal outcomes is limited. This study aimed to evaluate the association of these biomarkers with adverse maternal outcomes in women with severe pre-eclampsia. Markers of glycocalyx disruption may be further explored for their role along with clinical features and other biomarkers in identifying women at higher risk of maternal complications.

Validation of Risk Stratification for Cardiac Events in Pregnant Women With Valvular Heart Disease.

BACKGROUND: Most risk stratification tools for pregnant patients with heart disease were developed in high-income countries and in populations with predominantly congenital heart disease, and therefore, may not be generalizable to those with valvular heart disease (VHD). OBJECTIVES: The purpose of this study was to validate and establish the clinical utility of 2 risk stratification tools-DEVI (VHD-specific tool) and CARPREG-II-for predicting adverse cardiac events in pregnant patients with VHD. METHODS: We conducted a cohort study involving consecutive pregnancies complicated with VHD admitted to a tertiary center in a middle-income setting from January 2019 to April 2022. Individual risk for adverse composite cardiac events was calculated using DEVI and CARPREG-II models. Performance was assessed through discrimination and calibration characteristics. Clinical utility was evaluated with Decision Curve Analysis. RESULTS: Of 577 eligible pregnancies, 69 (12.1%) experienced a component of the composite outcome. A majority (94.7%) had rheumatic etiology, with mitral regurgitation as the predominant lesion (48.2%). The area under the receiver-operating characteristic curve was 0.884 (95% CI: 0.844-0.923) for the DEVI and 0.808 (95% CI: 0.753-0.863) for the CARPREG-II models. Calibration plots suggested that DEVI score overestimates risk at higher probabilities, whereas CARPREG-II score overestimates risk at both extremes and underestimates risk at middle probabilities. Decision curve analysis demonstrated that both models were useful across predicted probability thresholds between 10% and 50%. CONCLUSIONS: In pregnant patients with VHD, DEVI and CARPREG-II scores showed good discriminative ability and clinical utility across a range of probabilities. The DEVI score showed better agreement between predicted probabilities and observed events.

Diagnostic challenges in cerebral tuberculoma presenting with seizures in pregnancy.

Tuberculoma is an uncommon presentation of tuberculosis and is found in regions with a high prevalence of tuberculosis. This is rarely diagnosed during pregnancy. The presentation can mimic other etiologies such as eclampsia or cerebral venous sinus thrombosis so the diagnosis can be challenging, particularly when presenting with seizures in pregnancy. Described here is a woman in her first pregnancy who presented with seizures mimicking eclampsia and was suspected to have a brain tumour on neuroimaging. She was diagnosed to have a intracerebral tuberculoma on histopathological examination following surgical decompression after delivery.

Concurrent valve replacement and caesarean section for rheumatic mitral valve disease with refractory heart failure in late pregnancy.

Objective: To assess clinical characteristics and outcomes of women who underwent concurrent valve replacement with caesarean section for severe rheumatic mitral valve disease with refractory heart failure. Methods: All women admitted to a single centre from 2011 to 2020 with severe rheumatic mitral valve disease, having recurrent episodes of pulmonary edema on optimal medical therapy and contraindication to percutaneous balloon mitral valvotomy, who underwent concurrent valve replacement (for native valve disease) along with caesarean section, were included. Results: Among 1300 pregnancies with rheumatic heart disease, six underwent the concurrent procedure. All had replacement of mitral valve except one who had both aortic and mitral valve replacements, between 33 and 39 weeks of gestation. There were no maternal deaths, and there was one neonatal loss from late-onset sepsis. Conclusion: Pregnant women with severe rheumatic mitral valve disease with refractory heart failure, unsuitable for minimal access interventions, can be considered for a concurrent valve replacement with caesarean section.

Growth Pattern of Preterm Neonates with Fetal Growth Restriction: A Prospective Cohort Study.

OBJECTIVES: To compare the growth of preterm neonates with fetal growth restriction (FGR) and preterm neonates born appropriate-for-gestational-age (AGA) from birth to 12-18 mo of corrected age (CA). METHODS: In this prospective cohort study, 85 preterm neonates with FGR and 85 gestation- and gender-matched AGA neonates were followed up from birth till 12-18 mo corrected age. Anthropometric indices were compared at specific time points and the risk factors for underweight status were analyzed. RESULTS: Mean gestational age of the cohort was 32.8 ± 2.1 wk. Mean birth weight was 1414 ± 248 g in the FGR and 1806 ± 416 g in AGA neonates. At 12-18 mo of corrected age, a significantly greater proportion of FGR infants were wasted (24.3% vs. 7.2%, P = 0.005). A greater proportion of FGR infants were underweight (27% vs. 17.4%, P = 0.11), stunted (41.9% vs. 36.2%, P = 0.30), and microcephalic (27% vs. 23.1%, P = 0.36), although the differences were not statistically significant. Significant catch-up growth from 40 wk postmenstrual age (PMA) to 12-18 mo corrected age in weight (52.8% vs. 13.1%, P <0.001) and length (37.9% vs. 8.7%, P <0.001) was observed in the FGR neonates. The z-score of weight for age at 3 mo (adjusted OR 0.65, 95% CI: 0.52-0.8; P <0.001), the median time to full feeds (aOR: 1.10, 95% CI: 1.04-1.15; P = 0.001), and hypothyroidism (aOR 2.44, 95% CI: 1.46-4.08; P = 0.001), were independent predictors of underweight status at 12-18 mo. CONCLUSIONS: At 12-18 mo of corrected age, a significantly greater proportion of preterm FGR neonates were wasted compared to AGA ones. The former also exhibited significantly greater catch-up growth than the latter.

Metabolic Bone Disease in Preterm Neonates With Fetal Growth Restriction (FGR): A Prospective Cohort Study.

OBJECTIVE: To study the association of fetal growth restriction (FGR) with metabolic bone disease in preterm neonates. METHODOLOGY: This prospective cohort study included 94 preterm neonates with FGR as cases and an equal number of gestation-matched appropriate for gestational age (AGA) neonates without FGR as controls. The incidence of metabolic bone disease, and serum biochemical markers at various time intervals till 6 months corrected age were compared. The risk factors for metabolic bone disease and its association with stunting at 6 months of corrected age were studied. RESULTS: The incidence of metabolic bone disease, though higher in the FGR neonates (15.5%), was not significantly different from AGA neonates (6.7%) [RR (95%CI) 0.92-5.82; P=0.06]. Birth weight [aOR (95%CI) 0.8 (0.64-0.98); P=0.03] and time to reach full feeds [aOR (95%CI) 1.17 (1.01-1.36); P=0.03] were significantly associated with an increased risk of metabolic bone disease after adjusting for FGR status. Mean (SD) levels of calcium, phosphorus, alkaline phosphatase, parathormone (PTH), and vitamin D were similar in both groups. No significant association existed between metabolic bone disease and stunting at 6 months of corrected age [RR (95%CI) 2 (0.75-5.4); P=0.16]. CONCLUSION: FGR was not found to be significantly associated with metabolic bone disease in preterm neonates.

Comparing the efficacy of oral labetalol with oral amlodipine in achieving blood pressure control in women with postpartum hypertension: randomized controlled trial (HIPPO study-Hypertension In Pregnancy & Postpartum Oral-antihypertensive therapy).

De novo - or as a continuum of antenatal hypertension -postpartum hypertension complicates ~2% of pregnancies. Many maternal complications, such as eclampsia and cerebrovascular accidents, occur in the postpartum period. Despite widespread use of antihypertensives during pregnancy and childbirth, there is a paucity of data on preferred medications in the postpartum period. This randomized controlled study enrolled 130 women who were started on antihypertensives. They were randomized to receive oral Labetalol(LAB, maximum 900 mg per day in three doses) or oral Amlodipine(AML, maximum 10 mg per day given in two doses). In the immediate postpartum, all women were closely monitored for neurological symptoms, blood pressure, heart rate, respiratory rate, urine output, and deep tendon reflex. The primary outcome was the time to achieve sustained blood pressure control for 12 h from the initiation of medication; secondary outcomes included side effects of both medications. Mean time to achieve sustained blood pressure control was lower in women who received AML than in those who received LAB-(mean difference 7.2 h; 38 95% CI 1.4, 12.9, p = 0.011). There were fewer severe hypertensive episodes among those with AML than in those who received LAB. However, the proportion of women who continued to require antihypertensives at discharge was higher in the AML group than in the LAB group (55.4% versus 32.3%, p = 0.008). None of the participants developed drug-related side effects. Among women with postpartum persistence or new-onset hypertension, oral AML achieved sustained blood pressure control in a shorter duration, with fewer hypertensive emergencies than oral LAB. (CTRI/2020/02/023236).Trial Registration details: The study protocol was registered with Clinical Trial Registry of India with CTRI Number CTRI/2020/02/023236 dated 11.02.2020. Protocol can be accessed at https://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=40435&EncHid=&modid=&compid=%27,%2740435det%27 .

Postpartum Mental Health Status & Role Transition to Mother in Primigravid Women: A Cross-Sectional Study.

OBJECTIVE: : To assess the incidence of postpartum depression, maternal confidence about parenting and maternal-infant bonding characteristics in first-time mothers. BACKGROUND: : First-time mothers are usually unprepared for the transition into motherhood and may find it difficult to cope-up with this challenge leading to parenting stress, maternal-infant bonding disorders, and mental health problems. METHODS: : This cross-sectional study was conducted in a tertiary centre in South India, on 151 primigravid mothers who delivered a live-born healthy infant after 37 weeks' gestation. Assessment was done using Patient Health Questionnaire scale, Tamil version of the Postpartum Bonding Questionnaire and Maternal Confidence Questionnaire on the 2nd or 3rd postpartum day. RESULTS: : Incidence of postpartum depression was found to be 18.5%, with 6% having features of severe depression. All mothers had good perceived maternal confidence. Nearly one-third had one or more of the maternal-infant bonding disorders. Those who had a vaginal delivery were associated with bonding disorders (OR = 10.3; 95% CI 2.13-47.21) whereas moderate to severe postpartum depression was not associated with it on multivariate analysis. CONCLUSION: : First-time mothers were found to have good confidence in the transition to motherhood. However, the high incidence of maternal-infant bonding difficulty, especially in those with moderate to severe depression, suggests the need for initiating systematic and routine screening for postpartum mental health problems.

Maternal and perinatal outcome in pregnancies complicated with portal hypertension: a systematic review and meta-analysis.

BACKGROUND: Portal hypertension is secondary to either cirrhotic or non-cirrhotic causes, and complicating pregnancy poses a challenge to the treating team. A systematic review was performed to determine maternal and perinatal outcomes in women with portal hypertension. Outcomes were compared among those with cirrhotic (CPH) with non-cirrhotic portal hypertension (NCPH) as well as non-cirrhotic portal fibrosis (NCPF) with extra-hepatic portal vein obstruction (EHPVO). METHODS: Medline and EMBASE databases were searched for studies reporting outcomes among pregnant women with portal hypertension. Reference lists from relevant papers and reviews were hand-searched for appropriate citations. Data were extracted to describe maternal complications, obstetric and neonatal outcomes. A random-effects model was used to derive pooled estimates of various outcomes, and final estimates were reported as percentages with a 95% confidence interval (CI). Cumulative, sequential and sensitivity analysis was studied to assess the temporal trends of outcomes over the period. RESULTS: Information on 895 pregnancies among 581 patients with portal hypertension was included from 26 studies. Portal hypertension was diagnosed during pregnancy in 10% (95% CI 4-24%). There were 22 maternal deaths (0%, 95% CI 0-1%), mostly following complications from variceal bleeding or hepatic decompensation. Variceal bleeding complicated in 14% (95% CI 9-20%), and endoscopic interventions were performed in 12% (95% CI 8-17%) during pregnancy. Decompensation of liver function occurred in 7% (95% CI 3-12%). Thrombocytopenia was the most common complication (41%, 95% CI 23-60%). Miscarriages occurred in 14% (95% CI 8-20%), preterm birth in 27% (95% CI 19-37%), and low birth weights in 22% (95% CI 15-30%). Risk of postpartum hemorrhage was higher (RR 5.09, 95% CI 1.84-14.12), and variceal bleeding was lower (RR 0.51, 95% CI 0.30-0.86) among those with CPH compared to NCPH. Risk of various outcomes was comparable between NCPF and EHPVO. CONCLUSION: One in ten pregnancies complicated with portal hypertension is diagnosed during pregnancy, and thrombocytopenia is the most common complication. Hepatic decompensation and variceal bleeding remain the most common cause of maternal deaths, with reduced rates of bleeding and its complications reported following the introduction of endoscopic procedures during pregnancy. CPH increases the risk of postpartum hemorrhage, whereas variceal bleeding is higher among NCPH.

Efficacy of combination of transcervical Foley catheter and sublingual misoprostol versus sublingual misoprostol for labor induction in pre-eclampsia at 28-34 weeks.

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.

External validation of the Maternal Severity Index for predicting maternal death following potentially life-threatening complications during pregnancy and childbirth: a single-centre, prospective observational study.

OBJECTIVES: To perform an external validation to assess the usefulness of the Maternal Severity Index (MSI) in predicting maternal death among women with potentially life-threatening complications during pregnancy or childbirth. DESIGN: Prospective observational study. SETTING: A tertiary referral centre in southeastern India. PARTICIPANTS: 1833 women with potentially life-threatening complications identified using the WHO criteria. PREDICTOR ASSESSED: MSI calculated based on the severity markers of the WHO criteria for maternal near-miss. PRIMARY OUTCOME: Maternal death. STATISTICAL ANALYSIS: Receiver operating characteristics (ROC) curve analysis was performed to assess discriminative performance, and agreement between expected and observed deaths was plotted to determine calibration. RESULTS: The incidence of severe maternal outcomes was 10 per 1000 live births. There were 57 (151 per 100 000 live births) maternal deaths during the study period. Maternal Severity Score was significantly higher among those who died (2.8±1.3 vs 2.0±1.2, p<0.001). The mean MSI value was 1.03% (95% CI 0.7% to 1.2%). ROC curve analysis showed good discrimination (AUC(Area Under the Curve): 0.962, 95% CI 0.952 to 0.970); however, overfitting was seen with higher probabilities. The standardised mortality ratio (SMR) was 0.02 (95% CI 0.01 to 0.02), indicating good quality of care. CONCLUSIONS: The MSI has good discriminative performance in distinguishing who succumbs to life-threatening complications, but needs recalibration to avoid overfitting. SMR of less than 0.5 indicates fewer than expected deaths, suggesting good quality of care in reducing maternal mortality in the study population.

Indicators for maternal near miss: an observational study, India.

Objective: To compare the incidence of maternal near miss using the World Health Organization (WHO) near-miss tool and six other criteria sets, including criteria designed for low-resource settings or specifically for India. Methods: In a cohort study we used WHO severity indicators to identify women with potentially life-threatening conditions during pregnancy or childbirth admitted to a referral hospital in Puducherry, India, from May 2018 to April 2021. We analysed sociodemographic, clinical and laboratory data for each woman and calculated the incidence of maternal near miss and other process indicators for each set of criteria. Findings: We analysed data on 37 590 live births; 1833 (4.9%) women were identified with potentially life-threatening conditions, 380 women had severe maternal outcomes and 57 died. Applying the different sets of criteria to the same data, we found the incidence of maternal near miss ranged from 7.6 to 15.6 per 1000 live births. Only the Global Network criteria (which exclude laboratory data that may not be available in low-resource settings) and the WHO criteria could identify all women who died. Applying the criterion of any number of units of blood transfusion increased the overall number of women identified with near miss. Conclusion: The WHO and Global Network criteria may be used to detect maternal near miss in low-resource settings. Future studies could assess the usefulness of blood transfusion as an indicator for maternal near miss, especially in low- to middle-income countries where the indicator may not reflect severe maternal morbidity if the number of units received is not specified.