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In pregnant women with sickle cell disease, the risk of developing early-onset preeclampsia can be determined by measuring levels of a protein associated with placental function and development. These findings provide insight that may help clinicians to anticipate and mitigate adverse pregnancy outcomes and were published in the journal Blood Advances.

“Patients with sickle cell disease are at high risk for developing preeclampsia, but the challenge is that these patients produce placental growth factor even when they aren’t pregnant,” explained the lead study author, Kinga Malinowski, MD, MSc, who initiated the work as co-director of the Hematology in Pregnancy Program at Mount Sinai Hospital and assistant professor at the University of Toronto, both in Canada.

“This has raised the question of whether we can use low placental growth factor levels to predict preeclampsia in this patient population, and our study finds that, yes, we can, and with the same threshold that we use for patients without sickle cell disease,” said Dr. Malinowski, who now leads the Hematology-Focused Maternal Fetal Medicine Clinic at Hamilton Health Sciences and is a professor in the Department of Obstetrics and Gynaecology at McMaster University.

Placental growth factor (PlGF) is a protein produced by the placenta that supports the development of blood vessels. Measuring PlGF levels can help assess the risk of preeclampsia, a potentially deadly pregnancy complication that usually arises after 20 weeks and is characterized by high blood pressure and protein in the urine. Women with sickle cell disease are more than 2.4 times likely to develop preeclampsia during pregnancy when compared to women without this condition. This complication can inhibit growth of the fetus, result in premature birth, and is associated with stroke and potential organ damage in the mother.

In their study, the researchers retrospectively evaluated data on 83 pregnant women with sickle cell disease compared to 149 Black women without sickle cell disease, all patients at Mount Sinai Hospital in Toronto. All pregnancies had at least one PlGF measurement between 20- and 36-weeks’ gestation.

The researchers observed that median PlGF levels in individuals with sickle cell disease and early-onset preeclampsia were substantially lower at 20-24 weeks (78 pg/mL) compared to pregnancies with late-onset preeclampsia (158 pg/mL) or no preeclampsia (435 pg/mL). This trend mirrored that of the control group, with median PlGF levels of 55 pg/mL, 448 pg/mL, and 322 pg/mL for early-onset preeclampsia, late-onset preeclampsia, and no preeclampsia, respectively.

Low PlGF levels were effective at predicting the onset of preeclampsia in the pregnant women with sickle cell disease. Specifically, a prediction of early-onset preeclampsia achieved 100% sensitivity and specificity with a PlGF threshold of 87 pg/mL at 20 – 24 weeks, while a cut-off of 832 pg/mL at 20-24 weeks achieved 100% sensitivity and specificity for predicting late-onset preeclampsia. Additionally, the researchers found that pregnant women with sickle cell disease faced a particularly high risk of maternal vascular malperfusion, or inadequate blood flow, which is the most common placental injury linked to preeclampsia and fetal growth restriction. This risk was even higher in the presence of preeclampsia and was consistently associated with lower PlGF levels across all gestational stages.

“Patients with sickle cell disease are at higher risk for placental complications, so the ability to predict this risk is important for better pregnancy management,” said Dr. Malinowski. “With appropriate care, it is absolutely possible for patients with sickle cell disease to have a healthy, safe pregnancy for mom and baby.”

The study has some limitations, including that it was a single center study. Furthermore, other factors in addition to placental health can contribute to adverse pregnancy outcomes in women with sickle cell disease.

Dr. Malinowski and her colleagues are currently conducting an international study to validate a risk assessment calculator for pregnant patients with sickle cell disease, designed to identify those at highest risk of complications and guide timely interventions to reduce adverse outcomes.

Sickle cell disease is the most common inherited blood disorder and is marked by abnormally shaped red blood cells that can block blood vessels, leading to pain and infection. The condition affects more than 100,000 people in the United States and about one in every 365 Black or African American births.  

Reference:

Evangelia Vlachodimitropoulou, Tharshini Balasubramaniam, Nadine Shehata, Richard Ward, Kevin H.M. Kuo, John Charles Kingdom, Utility of Placental Growth Factor (PlGF) for preeclampsia prediction in pregnancies complicated by Sickle Cell Disease, Blood Advances, https://doi.org/10.1182/bloodadvances.2025016821.

In patients with heart failure (HF) caused by Chagas disease, sacubitril/valsartan was superior to enalapril for the composite primary endpoint, predominantly driven by a significant reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.

Chagas disease, caused by Trypanosoma cruzi infection, remains a serious health problem affecting more than 7 million people, primarily from Latin America.2 T. cruzi parasites are mainly transmitted by contact with faeces/urine of infected triatomine bugs. T. cruzi can also be transmitted by consumption of contaminated food/beverages, during pregnancy or birth, through blood/blood products, organ transplantation and laboratory accidents. Chagas disease is spreading around the world, predominantly due to migration of infected patients to other regions, including North America, Europe, Asia and Australia. Chagas cardiomyopathy is considered the most common and serious manifestation of chronic Chagas disease, occurring in 30–40% of infected people during long-term follow-up.2,3

“HF caused by Chagas disease has unique clinical features with worse prognosis than other causes of HF despite the fact that patients are often younger and have fewer comorbidities,” explained Professor Renato Lopes from Duke University Medical Center, Durham, USA, Principal Investigator of the PARACHUTE-HF trial. “There have been no prospective randomised trials testing the effects of standard treatments in patients with Chagas disease and HF. In the general HF population, the angiotensin receptor–neprilysin inhibitor, sacubitril/valsartan improved HF outcomes vs. the angiotensin-converting enzyme inhibitor, enalapril,4 and we compared these two agents in the largest trial in patients with Chagas disease and HF conducted to date.”

PARACHUTE-HF was an academic-led, open-label, blinded-endpoint adjudication, randomised trial conducted at more than 80 sites in Brazil, Argentina, Mexico and Colombia. Eligibility criteria included a diagnosis of Chagas disease confirmed by at least two different serological tests positive for Trypanosoma cruzi infection, left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association functional class II to IV symptoms and NT-proBNP ≥600 pg/ml or ≥400 pg/ml and hospitalisation for HF within the last 12 months. Participants were randomised 1:1 to either sacubitril/valsartan (50 or 100 mg twice daily titrated to a target of 200 mg twice daily) or enalapril (2.5 or 5 mg twice daily titrated to a target of 10 mg twice daily). The primary endpoint was a hierarchical composite outcome consisting of cardiovascular death, first hospitalisation for HF and the relative change from baseline to week 12 in NT-proBNP, analysed using a win ratio approach.5

In total, 922 patients were randomised. The mean age was 64 years, 42.0% were women, mean LVEF was 29.8% and 44.4% had had prior hospitalisation for HF.

Following pairwise comparisons, sacubitril/valsartan was associated with a 52% higher likelihood of a better primary outcome compared with enalapril (stratified unmatched win ratio 1.52; 95% confidence interval [CI] 1.28 to 1.82; p<0.001). Over a median of 25 months’ follow-up, rates were similar for sacubitril/valsartan vs. enalapril for cardiovascular death (hazard ratio [HR] 0.95; 95% CI 0.73 to 1.23) and first HF hospitalisation (HR 0.92; 95% CI 0.70 to 1.20). The significant difference in the primary outcome was predominantly driven by the percent change in NT-proBNP from baseline to 12 weeks: logarithmic median change from baseline was −30.6% in those assigned to sacubitril-valsartan and −5.5% in those assigned to enalapril (ratio of adjusted geometric mean change 0.68; 95% CI 0.62 to 0.75).

The safety profiles of the two agents were similar, with discontinuations due to adverse events occurring in 6.1% of patients with sacubitril/valsartan and 9.8% with enalapril.

Concluding, Professor Lopes said: “In patients with HF caused by Chagas disease, sacubitril/valsartan was superior to enalapril with respect to the primary outcome, predominantly driven by the 32% reduction in NT-proBNP levels at week 12. Our study provides the first randomised trial evidence to support a pharmacological treatment specifically in this high-risk population. PARACHUTE-HF shows that much-needed studies to better characterise chronic Chagas cardiomyopathy and to define the benefit/risk of new therapies in this condition are possible. In line with the global health spotlight of ESC Congress, the PARACHUTE-HF trial provides a successful model for international collaborations – in this field among cardiologists and infectious disease physicians − with the shared goal of evaluating the impact of new therapies on cardiovascular outcomes in patients with neglected diseases.” 

Researchers discovered that osteoarthritis (OA), previously thought to be a degenerative joint disease, is highly linked to the development and progression of cardiovascular-kidney-metabolic (CKM) multimorbidity. The research concluded that OA can be a clinically visible early predictor for recognizing persons at high risk of multi-organ metabolic deterioration. The study was published in Frontiers in Endocrinology journal by Yoe Zou and colleagues.

Jaipur: The Rajasthan High Court recently denied granting relief to a doctor, who filed a plea seeking to quash the FIR and subsequent proceedings in a case of medical negligence and cheating.

While considering the matter, the Single-Judge bench of Justice Anand Sharma held that the prosecution was valid and the investigating agency was not barred from conducting further probe and filing a charge sheet even after submitting a negative final report under Section 173(8) of the Criminal Procedure Code, 1973. 

The Court observed that the subsequent prosecution for medical negligence was rightly initiated, as it was supported by expert medical opinion, thereby complying with the Supreme Court’s guidelines in Jacob Mathew v. State of Punjab

The doctor was booked for medical negligence during the treatment of the complainant’s daughter-in-law for her first pregnancy. She was undergoing treatment for the pregnancy under the accused doctor’s supervision at a Jaipur-based hospital.

Back in January 2007, when the patient was admitted to the hospital, the doctor had assured the complainant of a normal delivery. However, allegedly, the treating doctor left for Ajmer the next day, leaving the patient in the hands of unskilled employees. Later, the child died due to the umbilical cord being wrapped around his neck.

It was alleged by the complainant that the newborn child died only due to the grave medical negligence of the accused doctor and the hospital employees, which could have been saved by a skilled medical expert.

Based on the complaint, an FIR was registered, and after the initial investigation, the police authorities submitted a negative final report on 14-12-2007, as no cognizable offence was found to be proved against the accused.

Following this, the investigating officer filed an application mentioning that after conducting further investigation, a decision was taken to file a charge sheet in the matter. Accordingly, permission was sought to return the file/case diary for filing the charge sheet. The Trial Court permitted this, and consequently, a charge sheet was filed and the Trial Court took cognisance of the offences punishable under Sections 304-A and 420 of the IPC and issued process against the accused.

Against the order framing charges, the accused filed a criminal revision petition, which was dismissed by the Revisional Court. Thereafter, the accused doctor approached the HC bench seeking relief.

While considering the matter, the HC bench observed that the first question that required consideration was whether, after filing the negative final report, and without there being any protest petition by the complainant, the trial court had the power to return the file/negative final report for the purpose of filing a charge sheet against the accused or not.

Examining Sections 173(3) and 173(8) of the CrPC, the HC bench held that a bare perusal of Section 173(8) of the CrPC specified that the investigating agency is not precluded from conducting further investigation despite submitting a final report and any other evidence found can be filed before the Magistrate with a further report.

“As per Section 173(3) Cr.P.C., the superior officer of police, pending the orders of the Magistrate, can direct officer-incharge of the police station to make further investigation and Section 173(8) Cr.P.C. specifies that despite submitting a final report, the investigating agency cannot be precluded from conducting further investigation and in case any further evidence is found, the same can be filed before the Magistrate with the further report,” noted the bench.

Referring to the judgment in the case of Ramachandran v. R. Udhayakumar, it was observed by the bench that the Supreme Court had held in this case that even if a negative final report was forwarded to the Magistrate, there is no bar in CrPC on further investigation of the matter and since the decision to further investigate the matter was taken by the investigating agency itself, there was no requirement for order of the Magistrate.

At this outset, the HC bench observed, “Thus, in view of above, it is clear that in the present case also the trial court has committed no mistake in returning the negative final report to the investigating agency and to allow filing of the charge sheet on discovery of new evidence during further investigation. Such process adopted either by the investigating agency or by the trial court is neither erroneous, nor illegal.”

While dealing with the accused’s submission that the FIR did not contain any allegations of medical negligence or of cheating, the Court noted that

“As regards argument raised on behalf of the petitioner that the FIR does not contain any allegations of medical negligence or of cheating, suffice to observe that it is settled proposition of law that FIR is not an encyclopedia and should be read with the material collected by the investigating agency during investigation. In the instant case, during further investigation, it is found that the petitioner was not a qualified Gynecologist and deceptively shown herself to be an expert Gynecologist so as to induce the innocent pregnant women to get themselves treated by her during their pregnancy and for delivery of the child as well. It has also been found that there were no technical experts or facility of sonography in hospital to conduct sonography of pregnant lady, which was a serious lapse as the position of foetus could be properly detected only through such technical facilities by the technical experts. It was also found that even there were serious lapses on the part of the petitioner. Therefore, merely the fact that FIR did not contain specific allegations constituting medical negligence or cheating, but after further investigation, there was sufficient material to infer that such offences have been committed by the petitioner, only on account of mere lack of proper words in the FIR, the same cannot be quashed by this Court.”

Thereafter, the Court dealt with the doctor’s argument that not obtaining the report of a medical expert was in contravention of the guidelines set out by the Supreme Court in Jacob Mathew v. State of Punjab. Referring to the concerned judgment, the HC bench observed,

“Meticulous examination of the aforesaid decision would reveal that a medical professional can be held liable for negligence in the cases where he does not possess requisite skill, which he professed to have possessed or, he did not exercise with reasonable competence in the given case, the skill which he did possess. The Hon’ble Supreme Court has also clearly observed that the investigating officer and the private complainant cannot always be supposed to have knowledge of medical science so as to determine whether the act of accused medical professional amounts to rash and negligent act within the domain of criminal law under Section 304-A IPC. Hence, Hon’ble Supreme Court directed that report of medical experts in such cases is necessary for prosecuting the medical professional.”

“In the instant case, as referred to hereinabove, during furher investigation, CID(CB)/the investigating agency has taken into account the reports given by Rajasthan Medical Council as well as Department of Obstetrics and Gynecology, SMS Medical College, Jaipur. Therefore, it cannot be said that any of the guidelines laid down by the Hon’ble Supreme Court in the case of Jacob Mathew (supra) has been violated in the instant case either by the investigating agency or by the trial court,” it also observed.

Accordingly, the court concluded that since was chargesheet was filed based on the reports by the competent medical experts/bodies, the prosecution had complied with the guidelines laid down in the case of Jacob Mathew.

“This Court is conscious of the settled legal position that the inherent powers under Section 482 Cr.P.C. are to be exercised with great caution and only in exceptional circumstances, where the material on record clearly discloses an abuse of the process of law or a grave miscarriage of justice resulting from failure to adhere to due process either by the investigating agency or by the concerned court. However, upon a careful examination of the entire record, this Court does not find any such illegality, irregularity or perversity warranting interference in exercise of its inherent jurisdiction under Section 482 Cr.P.C. Accordingly, the present criminal miscellaneous petition is devoid of merit and is hereby dismissed,” observed the bench, while dismissing the plea.

“However, it is made clear that this Court has not made any comments so as to affect the trial of the case against the petitioner and the observations made by this Court are confined to the scope of exercise of inherent jurisdiction under Section 482 Cr.P.C. and not for either influencing or affecting the trial of the case,” it clarified.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/rajasthan-hc-306884.pdf

Also Read: No Doctor would risk Reputation, Professional, Economic Stability by engaging in Medical Negligence: HC