Impact of a Community‐Oriented Comprehensive Clinical and Ultrasound Care Model Integrating Risk Stratification, Fetal Doppler, Health Education and Low‐Dose Aspirin on Preeclampsia Rates in Central India

Preeclampsia and associated hypertensive disorders of pregnancy represent a leading cause of global maternal and neonatal morbidity and mortality. Identification of women at high risk for developing preterm-preeclampsia and prophylaxis with low-dose aspirin has the potential to significantly reduce the rate of preterm-preeclampsia. In addition, risk assessment and monitoring of women in the second and third trimester of pregnancy, to aid in early detection of evolving disease, timely referral to specialist care, and active monitoring of women with confirmed or suspected preeclampsia is essential for improving maternal and neonatal outcomes. The angiogenesis-related biomarkers sFlt-1 and PlGF have been shown to have clinical value to aid in the prediction, diagnosis, and risk stratification of preeclampsia when used either alone or in combination with other risk factors. However, currently there is no consensus on the optimum strategy to link first trimester screening for preterm-preeclampsia with appropriate second and third trimester risk assessment strategies. This opinion paper will outline the current evidence for first trimester preeclampsia screening and prevention, as well as the evidence for various risk stratification approaches for detection of evolving preeclampsia through the second and third trimesters of pregnancy, and proposes a potential model integrating these tools. This article is protected by copyright. All rights reserved.

Aim To compare the magnitude of fetuses with congenital anomalies, pregnant women identified at high risk for preterm pre-eclampsia (PE) or with preterm PE, and with early fetal growth restriction (FGR) or high risk for FGR at the second trimester assessment at 20 to 24 weeks of gestation. Methods A standardized trimester-specific protocol that included clinical and demographic details, fetal biometry, estimated fetal weight (EFW), fetal abdominal circumference (FAC), mean arterial blood pressure and fetal Doppler studies was used to identify high risk for preterm PE and FGR. The Targeted Imaging for Fetal Anomalies (TIFFA) scan was used to identify congenital anomalies. In addition, 95% confidence intervals of the point estimates were derived, and the p -value was estimated to assess the statistical significance of the difference in proportions. Results Analysis of the data of 4,572 pregnant women screened between 20 and 24 gestation weeks showed a significantly lower prevalence ( p < 0.001) of congenital abnormalities (3.81%) compared to women diagnosed with early PE (2.71%) or with a high risk for PE (4.00%) and women (6.80%) with early FGR or at higher risk for fetal growth restriction with both EFW and FAC < 10th percentile. Conclusion The data on prevalence from Samrakshan show that the second-trimester assessment of pregnant women in India must expand its scope from the TIFFA scan to also focus on screening to identify women at high risk for preterm PE and FGR.

Aim To determine the effectiveness of the first trimester Samrakshan protocol for the identification of pregnant women at high risk for preterm pre-eclampsia (PE). Methods Samrakshan uses a protocol that integrates routine first-trimester ultrasound assessment at 11 to 14 gestation weeks with the measurement of mean arterial blood pressure and mean uterine artery pulsatility index assessment to determine a customized risk for preterm PE and fetal growth restriction. Based on the risk assessment, pregnant women are classified as high or low risk. Results The protocol had a high specificity (90.4%, 95% CI: 89.4%, 91.2%) and negative predictive value (98.1%, 95% CI: 97.6%, 99%) for preterm PE. The odds ratio and positive likelihood ratio for preterm PE were 16.7 (95% CI: 12.3, 22.6) and 6.64 (95% CI: 5.77, 7.63), respectively. Conclusions The positive likelihood ratio and odds ratios indicate that pregnant women identified as high risk for preterm PE using the first-trimester protocol of Samrakshan are significantly more likely to develop preterm PE than low-risk women.

To investigate the impact of aspirin administration on the incidence of preterm birth, according to the type of delivery and gestational age at preterm birth, and to examine the hypothesis that aspirin delays preterm delivery. This was a secondary analysis of a multicenter stepped-wedge cluster randomized trial of a first-trimester screen-and-prevent strategy for preterm pre-eclampsia (PE), which included 18 maternity/diagnostic units in 10 regions across Asia between 1 August 2019 and 28 February 2022. Women deemed to be at high risk for preterm PE according to a Bayes' theorem-based triple test, i.e. those with an adjusted risk for preterm PE of ≥ 1 in 100, received low-dose aspirin from < 16 weeks until 36 weeks' gestation. Outcome measures were the incidence of early preterm birth (24 + 0 to 31 + 6 weeks' gestation) and late preterm birth (32 + 0 to 36 + 6 weeks). The treatment effect of aspirin on the rate of preterm birth, stratified by gestational age at birth, type of delivery and presence of pregnancy complications, was estimated by computing the relative risks (RR) between the aspirin and non-aspirin groups with their 95% CIs. A shift model was designed to evaluate the effect of aspirin on preterm birth, based on the hypothesis that aspirin delays a preterm birth to a more advanced gestational age. In the randomized trial, 42 897/48 647 women accepted screening for preterm PE. Following exclusions, 10 294 and 27 965 women were included in the non-intervention and intervention phases, respectively. Of the 4688 women at high risk for preterm PE, 2909 (62.05%) received aspirin in the trial. Aspirin was associated with a 42% reduction in the risk of early preterm birth (adjusted relative risk (aRR), 0.577 (95% CI, 0.380-0.852)), and there was a significant upward trend in the rate of late preterm birth accordingly (test for trend, P < 0.01). Similar findings were observed for iatrogenic preterm birth and pregnancies with a small-for-gestational-age neonate. Additionally, aspirin was associated with a 60% reduction in the risk of iatrogenic early preterm birth in pregnancies with PE (aRR, 0.398 (95% CI, 0.192-0.788)). However, aspirin did not have a significant effect on iatrogenic late preterm birth in pregnancies with PE. Aspirin significantly delayed early preterm birth, with the effect decreasing by 0.26 (95% credibility interval, -0.40 to -0.05) weeks for each week of advancing gestation. At 24 weeks, aspirin delayed delivery by 3.63 weeks, while at 37 weeks, the delay was only 0.25 weeks. This secondary explanatory analysis found that early administration of aspirin could effectively reduce the risk of early preterm birth in women at high risk for preterm PE. While the reasons for preterm birth are often multifactorial, this study provides greater insight into the relationship between aspirin and different types of preterm birth at different gestational ages. Our findings support the hypothesis that aspirin helps to prevent preterm birth by delaying the timing of delivery, with a greater impact observed for deliveries that would have occurred at an earlier gestational age had aspirin not been administered. © 2025 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

To compare maternal haemodynamics in women at low and high risk for preterm pre-eclampsia (PE), and between those at high risk who are randomised to aspirin or placebo. Prospective, longitudinal observational study. Maternity units in six UK hospitals. Women participating in the Aspirin for Prevention of Preterm Pre-eclampsia (ASPRE) trial. The population comprised three groups of women: low risk for preterm PE (n=1362), high risk for preterm PE treated with aspirin (n=208) and high risk for preterm PE on placebo (n=220). Women had four visits during pregnancy: 11-14, 19-24, 30-34, and 35-37weeks' gestation. Blood pressure was measured with a device validated for pregnancy, and PE and maternal haemodynamics were assessed with a bioreactance monitor at each visit. A multilevel linear mixed-effects analysis was performed to examine longitudinal changes of maternal haemodynamic variables, controlling for demographic characteristics, past medical history and medication use. Longitudinal changes of cardiac output (CO), mean arterial pressure (MAP), and peripheral vascular resistance (PVR). The low-risk group demonstrated the expected changes with an increase in CO and reduction in MAP and PVR, with a quadratic change across gestation. In contrast, the high-risk groups had a declining CO, and higher MAP and PVR during pregnancy. The administration of aspirin did not appear to affect maternal haemodynamics. Women screened as high risk for preterm PE have a pathological cardiac adaptation to pregnancy and the prophylactic use of aspirin (150mg oral daily from the first trimester) in this group may not alter this haemodynamic profile. In women at high risk of pre-eclampsia, prophylactic use of aspirin may not alter the impaired maternal cardiac adaptation.

Aim The aim of this study was to assess the impact of the community-integrated Samrakshan model on perinatal mortality and morbidity in the Guna district of Central India Methods The trimester-specific Samrakshan protocols were used to screen pregnant women in the first, second, and third trimesters of pregnancy and to stratify risk for preterm preeclampsia (PE) and fetal growth restriction (FGR) in the screened population. Low-dose aspirin was recommended for women identified at high risk in the first trimester screening. Fifty training programs were conducted over the duration of the program for district health workers including Anganwadi workers, Accredited Social Health Activist (ASHA) personnel, and women and child health staff. Data on the development of PE, stages of FGR, preterm births (PTBs), birthweight, neonatal mortality, and perinatal mortality were collected and compared with the baseline year to assess trends. Results The program covered 168 Anganwadi centers and screened 1,021 women in the first trimester, 870 women in the second trimester, and 811 women in the third trimester of pregnancy from 2019 to 2022 and obtained details on childbirth outcomes from 1,219 women. PE did not occur in 71.58% of pregnant women identified at high risk for PE and occurred in only 2.37% of pregnant women identified at low risk for PE. The incidence of PE reduced from 9.36 to 1.61%, stage 1 FGR from 18.71 to 11.83%, PTB from 19.49 to 11.25%, and birthweight less than 2,500 g from 33.66 to 21.46% from 2019 to 2022. The neonatal mortality rate reduced from 26 to 7.47/1,000 live births from 2019 to 2022 and the perinatal mortality rate reduced from 33.90 to 18.87/1,000 childbirths from 2019 to 2022 in the Samrakshan program area at Guna. Conclusion The community-integrated model of Samrakshan in the Guna district has led to a significant reduction in perinatal morbidity and mortality in the program area.

BackgroundPreterm preeclampsia is an important cause of maternal and perinatal death and complications. It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of preterm preeclampsia.MethodsIn this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1776 women with singleton pregnancies who were at high risk for preterm preeclampsia to receive aspirin, at a dose of 150 mg per day, or placebo from 11 to 14 weeks of gestation until 36 weeks of gestation. The primary outcome was delivery with preeclampsia before 37 weeks of gestation. The analysis was performed according to the intention-to-treat principle.ResultsA total of 152 women withdrew consent during the trial, and 4 were lost to follow up, which left 798 participants in the aspirin group and 822 in the placebo group. Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as compared with 35 (4.3%) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20 to 0.74; P=0.004). Results were materially unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow-up. Adherence was good, with a reported intake of 85% or more of the required number of tablets in 79.9% of the participants. There were no significant between-group differences in the incidence of neonatal adverse outcomes or other adverse events.ConclusionsTreatment with low-dose aspirin in women at high risk for preterm preeclampsia resulted in a lower incidence of this diagnosis than placebo. (Funded by the European Union Seventh Framework Program and the Fetal Medicine Foundation; EudraCT number, 2013-003778-29; Current Controlled Trials number, ISRCTN13633058.)

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(Abstracted from N Engl J Med 2017;377:613–622) Since 1979, multiple studies have shown that low-dose aspirin in pregnancy can lower the occurrence of preeclampsia. Subsequent studies have shown that doses greater than 100 mg/d started before 16 weeks of gestation are most effective.

(BJOG. 2020;127:1018–1025) The Aspirin for Prevention of Preterm Pre-eclampsia (ASPRE) trial recently reported that aspirin (150 mg/d) may reduce the risk of preterm and early pre-eclampsia (PE) by 60% and 90%, respectively, in pregnant women screened in their first trimester. Although commonly used for the prevention and treatment of heart attacks or strokes in the general population, aspirin has also been shown to cause high blood pressure and exacerbate pre-existing heart failure. This may be explained in part by the inhibition of PGI2, a compensatory vasodilatory prostacyclin which results in vasoconstriction. In pregnant women at high risk for preterm PE, aspirin could lead to unfavorable cardiac outcomes. The aim of this study was to compare the hemodynamic effect of aspirin versus placebo in women at high-risk for preterm PE and to compare this effect in women at low risk versus high risk for developing this condition.

Context:India has a high perinatal mortality rate. The Indian Radiological and Imaging Association (IRIA) is supplementing efforts to address perinatal mortality in India through the Samrakshan program.Aims:To describe various elements of the Samrakshan program that aims to reduce perinatal mortality in India.Methods:Samrakshan focuses on two priority areas, preeclampsia (PE) and fetal growth restriction (FGR). Samrakshan aims at technical skill upgradation, specifically focused on improved interpretative ability, prognostic and therapeutic efficacy using Doppler studies, a free online learning platform and offline continuous medical educations (CMEs), building an evidence base from the program to develop policy and guidelines, and improving synergy with the RAKSHA program of IRIA and other fetal care stakeholders.Results:Two courses on Doppler studies focused on first trimester and third trimester, supplemented by case discussions and journal articles, have started on the online platform with 230 registrants. The first statewide CME was held at Indore. Samrakshan screening identified 10 (17.24%, 95% CI: 8.59, 29.43) women at high risk for preterm PE and 29 (50.00%, 95% CI 36.58, 63.42) women at high risk for FGR in the first trimester. Ten fetuses (7.63%, 95% CI: 3.72, 13.59) including 9 with stage 1 FGR were identified in the third-trimester screening.Conclusions:Samrakshan is a flagship program of IRIA that aims to reduce perinatal mortality in India through a synergistic, holistic approach that complements and supplements existing efforts in India.

Diagnosis and management of fetal growth restriction: the ISUOG guideline and comparison with the SMFM guideline.

IntroductionThis study aims to evaluate the safety of discontinuing aspirin treatment at 24–28 weeks in women at high risk after first‐trimester combined screening for preeclampsia (PE) and normal placental growth factor (PlGF) levels at 24–28 weeks of gestation.Material and MethodsThis is a post hoc analysis of the StopPRE trial, conducted at nine Spanish maternity hospitals from September 2019 to September 2021. In the StopPRE trial, all high‐risk single pregnancies identified during first‐trimester screening for PE were treated with 150 mg of daily aspirin. Out of 1604 eligible women with a soluble fms‐like tyrosine kinase‐1 to PlGF ratio (sFlt‐1/PlGF) ≤38 at 24–28 weeks, 968 were randomly assigned in a 1:1 ratio to either continue aspirin until 36 weeks (control group) or discontinue it (intervention group). In this secondary analysis, only women with PlGF ≥100 pg/mL at 24–28 weeks were included. As in the StopPRE trial, the non‐inferiority margin was set at a 1.9% difference in preterm PE incidence between the groups.ResultsAmong the 13 983 screened pregnant women, 1984 (14.2%) were deemed high‐risk for preterm PE, of which 397 (20.0%) were ineligible, 636 declined participation, and 32 were excluded. Ultimately, 919 women with PlGF >100 pg/mL were randomized and included in this analysis. Preterm PE occurred in 0.9% of the intervention group (4 out of 465) and 1.5% of the control group (7 out of 454), indicating non‐inferiority of aspirin discontinuation. There were no significant differences between the groups in adverse pregnancy outcomes before 37 weeks, at <34 weeks, or ≥37 weeks. Minor antepartum hemorrhage incidence was significantly lower in the intervention group (absolute difference, −5.96; 95% CI, −10.10 to −1.82).ConclusionsDiscontinuation of aspirin treatment at 24–28 weeks in women with PlGF levels ≥100 pg/mL was non‐inferior to continuing until 36 weeks for preventing preterm PE. However, these findings should be interpreted with caution, as they originate from a subanalysis of the StopPRE trial.

Uteroplacental dysfunction may not only result in pre-eclampsia (PE) but also in preterm birth (PTB), small-for-gestational-age (SGA) birth and stillbirth. The aim of this study is to evaluate the positive predictive value (PPV) of first-trimester combined PE screening for all of these placenta-mediated adverse pregnancy outcomes. Retrospective cohort study. Tertiary referral maternity unit. A total of 13 211 singleton pregnancies. First-trimester combined screening for preterm PE using the Fetal Medicine Foundation (FMF) algorithm. Hypertensive disorders of pregnancy (HDP), PTB, SGA birth and stillbirth were combined to assess composite adverse and severe adverse pregnancy outcomes (CAPO and CAPO-S). The PPVs for CAPO and CAPO-S were calculated for women with a combined risk for preterm PE of ≥1 in 50 and ≥1 in 100. First-trimester combined screening identified 2215 women (16.8%) with a risk of ≥1 in 100 for preterm PE. The PPVs for a risk of ≥1 in 100 for CAPO and CAPO-S were 38.8% and 18.2%, respectively. The equivalent PPVs for a risk of ≥1 in 50 were 45.1% and 21.1%, respectively. Women identified at high risk of preterm PE are also at increased risk of other placenta-mediated adverse pregnancy outcomes, such as PTB, SGA birth and stillbirth. Women at high risk for preterm PE after first-trimester screening may benefit from a higher surveillance care pathway, with interventions to mitigate all the adverse outcomes associated with placental dysfunction.

Although smoking during pregnancy may lead to many adverse effects, such as fetal growth restriction, placental abruption, stillbirth, and preterm labor, smoking is the only environmental exposure known to consistently reduce the risk of preeclampsia and gestational hypertension.1 The article by Wikstrom et al2 is a major step forward in understanding this protective effect. Using data from the Swedish Medical Birth Register in a large epidemiological study of >600 000 Nordic women, the authors conclude that use of Swedish snuff, a smokeless tobacco, did not reduce the risk of preeclampsia and gestational hypertension but that tobacco, when smoked, did. They infer that combustion products of tobacco, such as carbon monoxide (CO), protect against preeclampsia but that constituents of tobacco, such as nicotine, do not. The data strengthen and extend results of a previous smaller study using the Swedish Medical Birth Register, which had reported a similar association.3 Although snuff use did not reduce the risk of mild or severe preeclampsia, preeclampsia that began before or after 37 weeks of gestation, or preeclampsia with or without delivery of a small for gestational age (SGA) infant or stillbirth, smoking reduced the risk of all categories of preeclampsia except for preeclampsia with an SGA infant or stillbirth. Of considerable interest, using data from women who changed their tobacco habits at gestational weeks 30 to 32 from those reported at the first antenatal visit (usually before 15 weeks of gestation), Wikstrom et al2 found that women who had reported smoking at the first antenatal visit but no use of tobacco at 30 to …