Risk factors for labour induction and augmentation: a multicentre prospective cohort study in India.

Background: Guidelines for labour induction/augmentation involve evaluating maternal and fetal complications, and allowing informed decisions from pregnant women. This study aimed to comprehensively explore clinical and non-clinical factors influencing labour induction and augmentation in an Indian population. Methods: A prospective cohort study included 9305 pregnant women from 13 hospitals across India. Self-reported maternal socio-demographic and lifestyle factors, and maternal medical and obstetric histories from medical records were obtained at recruitment (≥28 weeks of gestation), and women were followed up within 48 h after childbirth. Maternal and fetal clinical information were classified based on guidelines into four groups of clinical factors: (i) ≥2 indications, (ii) one indication, (iii) no indication and (iv) contraindication. Associations of clinical and non-clinical factors (socio-demographic, healthcare utilisation and lifestyle related) with labour induction and augmentation were investigated using multivariable logistic regression analyses. Findings: Over two-fifths (n = 3936, 42.3%, 95% confidence interval [CI] 41.3-43.3%) of the study population experienced labour induction and more than a quarter (n = 2537, 27.3%, 95% CI 26.4-28.2%) experienced augmentation. Compared with women with ≥2 indications, those with one (adjusted odds ratio [aOR] 0.50, 95% CI 0.42-0.58) or no indication (aOR 0.24, 95% CI 0.20-0.28) or with contraindications (aOR 0.12, 95% CI 0.07-0.20) were less likely to be induced, adjusting for non-clinical characteristics. These associations were similar for labour augmentation. Notably, 34% of women who were induced or augmented did not have any clinical indication. Several maternal demographic (age at labour, parity and body mass index in early pregnancy), healthcare utilization (number of antenatal check-ups, duration of iron-folic acid supplementation and individuals managing childbirth) and socio-economic factors (religion, living below poverty line, maternal education and partner's occupation) were independently associated with labour induction and augmentation. Interpretation: Although decisions about induction and augmentation of labour in our study population in India were largely guided by clinical recommendations, we cannot ignore that more than a third of the women did not have an indication. Decisions could also be influenced by non-clinical factors which need further research. Funding: The MaatHRI platform is funded by a Medical Research Council Career Development Award (Grant Ref: MR/P022030/1) and a Transition Support Award (Grant Ref: MR/W029294/1).

Maternal and fetal factors associated with stillbirth in singleton pregnancies in 13 hospitals across six states in India: A prospective cohort study.

OBJECTIVE: This study aimed to investigate the incidence of and risk factors for stillbirth in an Indian population. METHODS: We conducted a secondary data analysis of a hospital-based cohort from the Maternal and Perinatal Health Research collaboration, India (MaatHRI), including pregnant women who gave birth between October 2018-September 2023. Data from 9823 singleton pregnancies recruited from 13 hospitals across six Indian states were included. Univariable and multivariable Poisson regression analysis were performed to examine the relationship between stillbirth and potential risk factors. Model prediction was assessed using the area under the receiver-operating characteristic (AUROC) curve. RESULTS: There were 216 stillbirths (48 antepartum and 168 intrapartum) in the study population, representing an overall stillbirth rate of 22.0 per 1000 total births (95% confidence interval [CI]: 19.2-25.1). Modifiable risk factors for stillbirth were: receiving less than four antenatal check-ups (adjusted relative risk [aRR]: 1.75, 95% CI: 1.25-2.47), not taking any iron and folic acid supplementation during pregnancy (aRR: 7.23, 95% CI: 2.12-45.33) and having severe anemia in the third trimester (aRR: 3.37, 95% CI: 1.97-6.11). Having pregnancy/fetal complications such as hypertensive disorders of pregnancy (aRR: 1.59, 95% CI: 1.03-2.36), preterm birth (aRR: 4.41, 95% CI: 3.21-6.08) and birth weight below the 10th percentile for gestational age (aRR: 1.35, 95% CI: 1.02-1.79) were also associated with an increased risk of stillbirth. Identified risk factors explained 78.2% (95% CI: 75.0%-81.4%) of the risk of stillbirth in the population. CONCLUSION: Addressing potentially modifiable antenatal factors could reduce the risk of stillbirths in India.

The complex relationship between iron status and anemia in pregnant and postpartum women in India: Analysis of two Indian study cohorts of uncomplicated pregnancies.

Low hemoglobin is widely used as an indicator of iron deficiency anemia in India and other low-and-middle income counties, but anemia need not accurately reflect iron deficiency. We examined the relationship between hemoglobin and biomarkers of iron status in antenatal and postnatal period. Secondary analysis of uncomplicated singleton pregnancies in two Indian study cohorts: 1132 antenatal women in third trimester and 837 postnatal women 12-72 h after childbirth. Associations of hemoglobin with ferritin in both data sets, and with sTfR, TSAT, and hepcidin in the postnatal cohort were examined using multivariable linear regression. Multinomial logistic regression was used to examine the association between severity of anemia and iron status. Regression models were adjusted for potential confounders. Over 55% of the women were anemic; 34% of antenatal and 40% of postnatal women had low ferritin, but 4% antenatal and 6% postnatal women had high ferritin. No evidence of association between hemoglobin and ferritin was observed (antenatal: adjusted coefficient [aCoef] -0.0004, 95% confidence interval [CI] -0.001, 0.001; postnatal: aCoef -0.0001, 95% CI -0.001, 0.001). We found a significant linear association of hemoglobin with sTfR (aCoef -0.04, 95% CI -0.07, -0.01), TSAT (aCoef -0.005, 95% CI -0.008, -0.002), and hepcidin (aCoef 0.02, 95% CI 0.02, 0.03) in postnatal women. Likelihood of low ferritin was more common in anemic than non-anemic women, but high ferritin was also more common in women with severe anemia in both cohorts. Causes of anemia in pregnant and postpartum women in India are multifactorial; low hemoglobin alone is not be a useful marker of iron deficiency.

Added-Value of Diffusion-Weighted Imaging (DWI) and Dynamic Contrast-Enhanced (DCE-MRI) Magnetic Resonance Imaging in the Preoperative Assessment of Cervical Cancer.

Purpose: To evaluate the added-value of diffusion-weighted imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in the preoperative assessment of carcinoma cervix. Methods: This prospective study was carried out on histopathologically proven 45 patients of carcinoma cervix presented to a tertiary care hospital with bleeding per vagina between August 2017 and July 2018. Relevant local per vaginal examination and MRI examination of the pelvis were performed. Results: A total of 45 patients with carcinoma of the cervix, having 11 patients (24.4%) in Stage-I, 22 patients (48.9%) in Stage-II, 3 patients (6.7%) in Stage-III and 9 patients (20%) in stage-IV, were included in this study sample. The mean ADC value of the carcinoma of cervix was 0.802 ± 0.123 [SD] × 10-3 mm2/s. The stage-I carcinoma cervix had a mean ADC value of 0.915 ± 0.109 [SD] × 10-3 mm2/s, Stage-II 0.778 ± 0.099 [SD] × 10-3 mm2/s, Stage-III 0.762 ± 0.123 [SD] × 10-3 mm2/s and Stage-IV 0.737 ± 0.116 [SD] × 10-3 mm2/s. ROC curve analysis showed the percentage of signal intensity changes within cervical tumor on arterial phase of DCE-MRI had a threshold value of 42.25 in differentiating Stage-I carcinoma of cervix from other stages with a sensitivity of 81.8% and specificity of 44.1%. Conclusion: The DWI and DCE-MRI added valuable inputs over conventional MR sequences in the early diagnosis and preoperative staging of carcinoma cervix. DCE-MRI had a high accuracy for assessing the cervical stromal and parametrial invasions, which helps in selecting the optimal therapeutic protocol and prognostication in gynecological malignancies.

Relationship between anaemia, coagulation parameters during pregnancy and postpartum haemorrhage at childbirth: a prospective cohort study.

OBJECTIVES: To investigate the association between coagulation parameters and severity of anaemia (moderate anaemia: haemoglobin (Hb) 7-9.9 g/dL and severe anaemia: Hb <7 g/dL) during pregnancy and relate these to postpartum haemorrhage (PPH) at childbirth. DESIGN: A prospective cohort study of pregnant women recruited in the third trimester and followed-up after childbirth. SETTING: Ten hospitals across four states in India. PARTICIPANTS: 1342 pregnant women. INTERVENTION: Not applicable. METHODS: Hb and coagulation parameters: fibrinogen, D-dimer, D-dimer/fibrinogen ratio, platelets and international normalised ratio (INR) were measured at baseline. Participants were followed-up to measure blood loss within 2 hours after childbirth and PPH was defined based on blood loss and clinical assessment. Associations between coagulation parameters, Hb, anaemia and PPH were examined using multivariable logistic regression models. OUTCOMES MEASURES: Adjusted OR with 95% CI. RESULTS: In women with severe anaemia during the third trimester, the D-dimer was 27% higher, mean fibrinogen 117 mg/dL lower, D-dimer/fibrinogen ratio 69% higher and INR 12% higher compared with women with no/mild anaemia. Mean platelets in severe anaemia was 37.8×109/L lower compared with women with moderate anaemia. Similar relationships with smaller effect sizes were identified for women with moderate anaemia compared with women with no/mild anaemia. Low Hb and high INR at third trimester of pregnancy independently increased the odds of PPH at childbirth, but the other coagulation parameters were not found to be significantly associated with PPH. CONCLUSION: Altered blood coagulation profile in pregnant women with severe anaemia could be a risk factor for PPH and requires further evaluation.

Maternal and perinatal Health Research Collaboration, India (MaatHRI): methodology for establishing a hospital-based research platform in a low and middle income country setting.

Background: Maternal and perinatal Health Research collaboration, India (MaatHRI) is a research platform that aims to improve evidence-based pregnancy care and outcomes for mothers and babies in India, a country with the second highest burden of maternal and perinatal deaths. The objective of this paper is to describe the methods used to establish and standardise the platform and the results of the process. Methods: MaatHRI is a hospital-based collaborative research platform. It is adapted from the UK Obstetric Surveillance System (UKOSS) and built on a pilot model (IndOSS-Assam), which has been extensively standardised using the following methods: (i) establishing a network of hospitals; (ii) setting up a secure system for data collection, storage and transfer; (iii) developing a standardised laboratory infrastructure; and (iv) developing and implementing regulatory systems. Results: MaatHRI was established in September 2018. Fourteen hospitals participate across four states in India - Assam, Meghalaya, Uttar Pradesh and Maharashtra. The research team includes 20 nurses, a project manager, 16 obstetricians, two pathologists, a public health specialist, a general physician and a paediatrician. MaatHRI has advanced standardisation of data and laboratory parameters, real-time monitoring of data and participant safety, and secure transfer of data. Four observational epidemiological studies are presently being undertaken through the platform. MaatHRI has enabled bi-directional capacity building. It is overseen by a steering committee and a data safety and monitoring board, a process that is not normally used, but was found to be highly effective in ensuring data safety and equitable partnerships in the context of low and middle income countries (LMICs). Conclusion: MaatHRI is the first prototype of UKOSS and other similar platforms in a LMIC setting. The model is built on existing methods but applies new standardisation processes to develop a collaborative research platform that can be replicated in other LMICs.

Unsafe abortion and abortion-related death among 1.8 million women in India.

INTRODUCTION: Unsafe abortion is a preventable cause of maternal mortality. While studies report high number of abortions in India, the population-level rates of unsafe abortion and their risk factors are not well understood. Our objective was to analyse the rates of and risk factors for unsafe abortion and abortion-related maternal death in India. METHODS: We conducted a secondary analysis of data from 1 876 462 pregnant women aged 15-58 years from nine states in the Indian Annual Health Survey (2010-2013). We calculated the rate of unsafe abortion and abortion-related mortality with 95% CI. Multivariable logistic regression models examined the associations of sociodemographic characteristics, health seeking behaviours and family planning with unsafe abortion and abortion-related mortality. RESULTS: There were 89 447 abortions among 1 876 462 pregnant women in 2007-2011 (4.8%; 95% CI 4.8 to 4.9). Of these, 58 266 were classified as unsafe (67.1%; 95% CI 66.7 to 67.5). There were 253 abortion-related maternal deaths (0.3%; 95% CI 0.2 to 0.3). Factors associated with unsafe abortion: maternal age 20-24 years (adjusted OR (aOR): 1.13; 95% CI 1.09 to 1.18), illiteracy (aOR: 1.48; 95% CI 1.39 to 1.59), rural residence (aOR: 1.26; 95% CI 1.21 to 1.32), Muslim religion (aOR: 1.16; 95% CI 1.12 to 1.22), Schedule caste social group (aOR: 1.08; 95% CI 1.04 to 1.12), poorest asset quintile (aOR: 1.45; 95% CI 1.38 to 1.53), antenatal care (aOR: 0.69; 95% CI 0.67 to 0.72), no surviving children (aOR: 1.30; 95% CI 1.16 to 1.46), all surviving children being female (aOR: 1.12; 95% CI 1.07 to 1.17), use of family planning methods (aOR: 0.69; 95% CI 0.66 to 0.71). Factors associated with abortion-related deaths: maternal age 15-19 (aOR: 7.79; 95% CI 2.73 to 22.23), rural residence (aOR: 3.28; 95% CI 1.76 to 6.11), Schedule tribe social group (aOR: 4.06; 95% CI 1.39 to 11.87). CONCLUSION: Despite abortion being legal, the high estimated prevalence of unsafe abortion demonstrates a major public health problem in India. Socioeconomic vulnerability and inadequate access to healthcare services combine to leave large numbers of women at risk of unsafe abortion and abortion-related death.