Sikkim Cardiologist Murder Case: Man gets life imprisonment after 3 years

Gangtok: A District and Sessions Court has sentenced a man to life term jail for killing a renowned cardiologist at the state-run STNM Hospital in 2021. The court also imposed a fine of Rs 10,000 on him.

A man was sentenced to life imprisonment by a court in Gangtok for the murder of a doctor at the state-run STNM Hospital.

The incident took place on December 14, 2021, when Dorji Thinley Bhutia assaulted a female hospital employee over personal issues. When Dr. Sanjay Upreti, a renowned cardiologist, intervened, Bhutia repeatedly stabbed him. Dr. Upreti succumbed to his injuries three days later while receiving treatment.

Medial Dialogues team had earlier reported that in a heart-wrenching incident, the cardiologist attached to New STNM Hospital, Gangtok who was stabbed in a brutal knife attack while trying to save a staff died in a private hospital in North Bengal’s Siliguri. The cardiologist passed away at 3.40 AM, said a senior consultant associated with CTVC, Neoita Getwell Health Care Centre in Siliguri where the cardiologist was admitted.  

According to a PTI news report, District and Sessions Court Judge Jyoti Khadka sentenced Bhutia to life imprisonment after convicting him under IPC section 302 (murder).  

Also Read:Bhubaneshwar Doctor Couple murder case: 5 persons sentenced to life imprisonment

The court also imposed a fine of Rs 10,000 on him.

Additionally, Bhutia received a 10-year sentence under IPC section 307 (attempt to murder), with a Rs 1,000 fine.

The court also sentenced him to 10 years of imprisonment under IPC section 307 (attempt to murder), besides imposing a fine of Rs 1,000.

Bhutia was also sentenced to one year in jail under IPC section 353 that deals with the assault of the public servant.

All three jail terms will run simultaneously, the court said, news agency PTI reported.

Also Read:Odisha Medical Officer gets 2 years imprisonment in bribery case

Powered by WPeMatico

Breakthrough in Obesity Treatment: Tirzepatide Shows Promise in Chinese Adults – SURMOUNT-CN Trial

China: In the relentless battle against obesity, a new contender has emerged: tirzepatide. The results of the SURMOUNT-CN randomized clinical trial have ignited excitement within the medical community, as they unveil the potential of this novel drug in tackling obesity among Chinese adults.

The study, published in the Journal of the American Medical Association (JAMA), showed a greater reduction in body weight with tirzepatide (Zepbound) than with placebo among Chinese adults with obesity or overweight. Participants on tirzepatide and lifestyle intervention lost an average of 15.1% more body weight with the highest dose compared with placebo after 52 weeks.

“In the study of 210 adults without diabetes, mean percent change in body weight at week 52 was −13.6% and −17.5% with tirzepatide 10 mg and 15 mg, respectively, compared with −2.3% with placebo; the differences between each tirzepatide group and the placebo group were statistically significant,” the researchers reported.

Obesity, a complex condition with multifactorial origins, has reached epidemic proportions globally, posing significant health risks and economic burdens. Traditional approaches to weight management, including diet and exercise interventions, often fall short of achieving sustainable outcomes for many individuals. As such, the quest for effective pharmacological interventions remains a pressing priority.

Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist has garnered attention for its potent effects on glycemic control and weight reduction in individuals with type 2 diabetes mellitus (T2DM). Lin Zhao, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China, and colleagues aimed to assess the safety and efficacy of treatment with tirzepatide for weight reduction in Chinese adults with overweight or obesity and weight-related comorbidities.

For this purpose, the researchers conducted a randomized, double-blind, placebo-controlled, phase 3 clinical trial at 29 centers in China from 2021 to 2022. It included Chinese adults (aged ≥18 years) with a body mass index (BMI) greater than or equal to 28 or greater than or equal to 24 and at least one weight-related comorbidity, excluding diabetes.

Participants were randomly assigned in a 1:1:1 ratio to receive once-weekly, subcutaneous 10-mg (n = 70) or 15-mg (n = 71) tirzepatide or placebo (n = 69), plus a lifestyle intervention, for 52 weeks.

Co-primary endpoints included the percent change in body weight from baseline and weight reduction of at least 5% at week 52. Safety and efficacy analyses were performed on an intention-to-treat population.

The following were the key findings of the study:

  • Of 210 randomized participants (49.0% female; mean age, 36.1 years; body weight, 91.8 kg; BMI, 32.3), 95.7% completed the trial.
  • The mean change in body weight at week 52 was −13.6% with tirzepatide 10 mg, −17.5% with tirzepatide 15 mg, and −2.3% with placebo (difference between 10 mg and placebo, −11.3%; the difference between 15 mg and placebo, −15.1%).
  • The percentage of participants achieving body weight reductions of 5% or greater was 87.7% with tirzepatide 10 mg, 85.8% with tirzepatide 15 mg, and 29.3% with placebo.
  • The most frequent treatment-emergent adverse events with tirzepatide were gastrointestinal. Most were mild to moderate in severity, with few events leading to treatment discontinuation (<5%).

“In Chinese adults with overweight or obesity, once-weekly treatment with tirzepatide 10 mg or 15 mg led to statistically significant and clinically meaningful weight reduction with an acceptable safety profile,” the researchers wrote.

Reference:

Zhao L, Cheng Z, Lu Y, et al. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA. Published online May 31, 2024. doi:10.1001/jama.2024.9217

Powered by WPeMatico

Triglyceride glucose index superior to modified TyG indices for predicting cardiovascular diseases: Study

China: In the quest for more accurate predictors of cardiovascular disease (CVD) risk, researchers in China have turned their attention to the triglyceride glucose index (TyG index) and its modified counterparts. A recent study comparing these indices has revealed intriguing findings regarding their effectiveness in predicting CVD risk among middle-aged and older Chinese adults.

The researchers found that TyG and TyG-waist-to-height ratio (WHtR) are significantly associated with new-onset CVDs, and the TyG outperformed the modified TyG indices to identify individuals at risk of an incident cardiovascular event.

The findings, published in Cardiovascular Diabetology, support the superiority of the TyG index over the modified TyG indices using obesity-related parameters for risk stratification and predicting future cardiovascular disease (CVD).

Cardiovascular diseases, including heart disease and stroke, are leading causes of mortality worldwide, with risk factors such as obesity, diabetes, and dyslipidemia playing significant roles. Traditional risk assessment tools rely on factors like cholesterol levels and blood pressure measurements. However, emerging evidence suggests that novel biomarkers, such as the TyG index, may offer additional insights into cardiovascular risk.

The triglyceride and glucose (TyG) index, a surrogate marker of insulin resistance, has been validated as a predictor of CVD. However, the effects remain unknown of TyG-related indices combined with obesity markers on CVD. Therefore, Zhonghang Xu, China-Japan Union Hospital of Jilin University, Jilin University, Jilin, China, and colleagues aimed to investigate the associations between the TyG index and modified TyG indices with new-onset cardiovascular disease and the time-dependent predictive capacity using a nationally representative cohort.

For this purpose, the researchers conducted a retrospective observational cohort study using China Health and Retirement Longitudinal Study (CHARLS) data of 7 115 participants. The TyG index was calculated as Ln [fasting triglyceride (mg/dL) × fasting glucose (mg/dL)/2].

The modified TyG indices were developed by combining TyG with waist circumference (WC), body mass index (BMI), and waist-to‐height ratio (WHtR). Adjusted Cox proportional hazards regression was used to analyze the association and predictive capacity based on hazard ratio (HR) and Harrell’s C‐index.

Based on the study, the researchers reported the following findings:

· Over a 7-year follow‐up period, 2136 participants developed cardiovascular disease, including 1633 cases of coronary heart disease and 719 cases of stroke.

· Compared with the lowest tertile group, the adjusted HR for new-onset cardiovascular disease in the highest tertile for TyG, TyG-BMI, TyG-WHtR, and TyG-WC were 1.215, 1.073, 1.112, and 1.078, respectively.

· The C‐indices of the TyG index for cardiovascular disease onset were higher than other modified TyG indices.

· Similar results were observed for coronary heart disease and stroke.

In conclusion, the study highlights the potential of the triglyceride glucose index and its modified versions as valuable tools for predicting cardiovascular disease risk in middle-aged and older Chinese adults. By refining risk assessment strategies, these indices could ultimately contribute to more effective prevention and management of cardiovascular diseases, reducing the burden of these conditions on public health.

Reference:

Cui, C., Qi, Y., Song, J. et al. Comparison of triglyceride glucose index and modified triglyceride glucose indices in prediction of cardiovascular diseases in middle aged and older Chinese adults. Cardiovasc Diabetol 23, 185 (2024). https://doi.org/10.1186/s12933-024-02278-z

Powered by WPeMatico

Zerlasiran, a promising intervention targeting lipoprotein(a), shows positive results in clinical trial

USA: In the realm of cardiovascular health, the quest to combat elevated levels of lipoprotein(a) [Lp(a)], a significant risk factor for cardiovascular disease (CVD), has long been a challenge. However, a recent clinical trial investigating the efficacy of Zerlasiran, a novel short-interfering RNA (siRNA) therapy targeting Lp(a), has yielded promising results, offering hope for millions at risk of CVD.

The trial enrolling 32 healthy participants and 36 patients with cardiovascular disease and lipoprotein(a) concentrations 150 nmol/L or greater, revealed that zerlasiran was well tolerated and produced sustained reductions in lipoprotein(a) concentrations, supporting further development. No serious adverse events occurred.

“The median change from baseline in lipoprotein(a) concentration 365 days after single doses for placebo, 300 mg, and 600 mg were 14%, −30%, and −29%. The maximal median change from baseline following two doses of placebo, 200 mg, 300 mg, and 450 mg were 7%, −97%, −98%, and −99%,” the researchers reported in the Journal of the American Medical Association (JAMA)

Lipoprotein(a) is a causal risk factor for calcific aortic stenosis and atherosclerotic cardiovascular disease (ASCVD), with no pharmacological treatments approved by regulatory authorities. Considering this, Steven E. Nissen, Cleveland Clinic Center for Clinical Research, Cleveland, Ohio, and colleagues aimed to assess the tolerability and safety of zerlasiran and its effects on serum lipoprotein(a) concentrations.

For this purpose, the researchers conducted a single- and multiple-dose study in healthy participants and patients with stable ASCVD, respectively, with Lp (a) serum concentrations greater than 150 nmol/L, at seven research sites in the Netherlands, the US, Australia, and the UK between 2020 and 2023.

Participants were randomized to receive (1) a single subcutaneous dose of placebo (n = 8), zerlasiran 300 mg (n = 6) or 600 mg (n = 6); or (2) two doses of placebo (n = 9), zerlasiran 200 mg (n = 9) at intervals of 4 weeks or 300 mg (n = 9) or 450 mg (n = 9) at an 8-week interval.

The study’s primary outcome was tolerability and safety. Secondary outcomes included serum zerlasiran levels and effects on lipoprotein(a) serum concentrations.

The researchers reported the following findings:

  • Among 37 patients in the multiple-dose group (mean age, 56 years; 42% women), 36 completed the trial. Among 14 participants with extended follow-up after single doses, 13 completed the trial.
  • There were no serious adverse events.
  • Median baseline lipoprotein(a) concentrations in the multiple-dose group were 288 nmol/L.
  • Median changes in lipoprotein(a) concentration at 365 days after single doses were 14% for the placebo group, −30% for the 300 mg of zerlasiran group, and −29% for the 600-mg dose group.
  • After two doses, maximal median changes in lipoprotein(a) concentration were 19 nmol/L for the placebo group, −258 nmol/L for the 200 mg of zerlasiran group, −310 nmol/L for the 300-mg dose group, and −242 nmol/L for the 450-mg dose group, with maximal median percent change of 7%, −97%, −98%, and −99%, respectively, attenuating to 0.3%, −60%, −90%, and −89% 201 days after administration.

The findings showed that zerlasiran was well tolerated and reduced lipoprotein(a) concentrations with infrequent administration.

“These findings support further development of zerlasiran in phase 2 and 3 clinical trials,” the researchers wrote.

Reference:

Nissen SE, Wolski K, Watts GF, et al. Single Ascending and Multiple-Dose Trial of Zerlasiran, a Short Interfering RNA Targeting Lipoprotein(a): A Randomized Clinical Trial. JAMA. 2024;331(18):1534–1543. doi:10.1001/jama.2024.4504

Powered by WPeMatico

Could getting enough sleep help prevent osteoporosis?

As part of the University of Colorado Department of Medicine’s annual Research Day, held on April 23, faculty member Christine Swanson, MD, MCR, described her National Institutes of Health-funded clinical research on whether adequate sleep can help prevent osteoporosis.

“Osteoporosis can occur for many reasons such as hormonal changes, aging, and lifestyle factors,” said Swanson, an associate professor in the Division of Endocrinology, Metabolism, and Diabetes. “But some patients I see don’t have an explanation for their osteoporosis.

“Therefore, it’s important to look for novel risk factors and consider what else changes across the lifespan like bone does-sleep is one of those,” she added.

How bone density and sleep change over time

In people’s early- to mid-20s, they reach what is called peak bone mineral density, which is higher for men than it is for women, Swanson said. This peak is one of the main determinants of fracture risk later in life.

After reaching this peak, a person’s bone density remains roughly stable for a couple of decades. Then, when women enter the menopausal transition, they experience accelerated bone loss. Men also experience bone density decline as they age.

Sleep patterns also evolve over time. As people get older, their total sleep time decreases, and their sleep composition changes. For instance, sleep latency, which is the time it takes to fall asleep, increases with age. On the other hand, slow wave sleep, which is deep restorative sleep, decreases as we age.

“And it’s not just sleep duration and composition that change. Circadian phase preference also changes across the lifespan in both men and women,” Swanson said, referring to people’s preference for when they go to sleep and when they wake up.

How can sleep relate to our bone health?

Genes that control our internal clock are present in all of our bone cells, Swanson said.

“When these cells resorb and form bone, they release certain substances into the blood that let us estimate how much bone turnover is going on at a given time,” she said.

These markers of bone resorption and formation follow a daily rhythm. The amplitude of this rhythm is larger for markers of bone resorption-which refers to the process of breaking down bones-than it is for markers of bone formation, she said.

“This rhythmicity is likely important for normal bone metabolism and suggests that sleep and circadian disturbance could directly affect bone health,” she said.

Researching the connection between sleep and bone health

To further understand this relationship, Swanson and colleagues researched how markers of bone turnover responded to cumulative sleep restriction and circadian disruption.

For this study, participants lived in a completely controlled inpatient environment. The participants did not know what time it was, and they were put on a 28-hour schedule instead of a 24-hour day.

“This circadian disruption is designed to simulate the stresses endured during rotating night shift work and is roughly equivalent to flying four time zones west every day for three weeks,” she said. “The protocol also caused participants to get less sleep.”

The research team measured bone turnover markers at the beginning and end of this intervention and found significant detrimental changes in bone turnover in both men and women in response to the sleep and circadian disruption. The detrimental changes included declines in markers of bone formation that were significantly greater in younger individuals in both sexes compared to the older individuals.

In addition, young women showed significant increases in the bone resorption marker.

If a person is forming less bone while still resorbing the same amount-or even more-then, over time, that could lead to bone loss, osteoporosis, and increased fracture risk, Swanson said.

“And sex and age may play an important role, with younger women potentially being the most susceptible to the detrimental impact of poor sleep on bone health,” she said.   

Powered by WPeMatico

Canadian Breast Cancer Guidelines Embrace Biennial Screening: A Shift in Approach

Canada: In a landmark update, the Canadian Task Force on Preventive Health Care (CTFPHC) has revised its guidelines for breast cancer screening, recommending that Canadian women at average breast cancer risk should undergo biennial or triennial screening and make decisions based on individual values.

The updated guidance on breast cancer screening, released on May 30, recommends that women between the ages of 40 to 49 not be systematically screened for the disease with mammography but rather make their screening decisions based on informed discussions with their primary care provider.

The guidelines differ slightly from the the recent U.S. Preventive Services Task Force (USPSTF) breast cancer screening guidelines, which recommended biennial screening, and do not support supplemental screening in women with dense breasts or with a family history of breast cancer.

“The risk-benefit in this category does not align with patient preferences and values, but we feel it’s very important that once that information is received if people want access, it should be there,” said Kate Miller, MD, from McMaster University in Hamilton, Ontario, Canada. Miller is a member of the task force.

The CTFPHC in February 2023 decided that the 2018 guidelines required updating. The group comprised six family physicians, four specialists, and two nurse practitioners; this recommendation update also involved a working group of a medical oncologist, a surgical oncologist, a radiation oncologist, a radiologist, and three patient partners. CTFPHC reviewed evidence from literature searches, systematic reviews, other data, and modeling and placed them into a decision framework.

For women aged 40 to 49, based on the current evidence, the group suggests not systematically screening with mammography. Because individual values and preferences may differ, those who want to be screened after being informed of the benefits and harms should be offered to be screened every 2 to 3 years (conditional recommendation, very low certainty).

“In ages 40 to 49, we found that the harms may outweigh the benefits,” the group stated.

For women aged 50 to 74, the group suggests screening with mammography every 2 to 3 years. Because individual values and preferences may differ, women aged 50 to 74 must have information about the benefits and harms of screening to make their decision (conditional recommendation, very low certainty).

“In ages 50 to 74, we found that the benefits may outweigh the harms,” the group stated.

For women aged 75 and above, the group suggests against screening with mammography (conditional recommendation, very low certainty).

“In ages 75 and above, there is a lack of information. But there is concern that the harms outweigh the benefits if screening continues beyond age 74,” the group stated.

For women with moderately increased risk due to high breast density, the group did not find any evidence of the benefits of supplemental screening for outcomes important to patients (e.g., stage at diagnosis, death).

Therefore, they suggest against the use of MRI or ultrasound as supplementary screening tests for people with dense breasts (conditional recommendation, very low certainty).

For women with moderately increased risk due to a family history of breast cancer, the group did not find any evidence of the benefits of supplemental screening for outcomes important to patients (e.g., stage at diagnosis, death).

Therefore, they suggest against the use of MRI or ultrasound as supplementary screening tests for people at moderately increased risk due to a family history of breast cancer (conditional recommendation, very low certainty).

Reference:

BREAST CANCER (UPDATE) – DRAFT RECOMMENDATIONS (2024)

Powered by WPeMatico

Two-stage ligament reconstruction effective to preserve function in knee dislocation, claims study

Two-stage ligament reconstruction with remnant preservation may preserve function in knee dislocation suggests a new study published in the BMC Surgery.

Knee dislocation is an uncommon and severe injury that frequently induced by high-energy impact injuries, ranging from automobile accidents to contact sports.

The purpose of this study was to evaluate the clinical outcomes of two-stage reconstruction (peripheral reconstruction in phase I and central anterior cruciate ligament (ACL) / posterior cruciate ligament (PCL) reconstruction in phase II) with remnant preservation for patients with knee dislocation.

A total of 70 patients (10 IIIM, 17 IIIL, and 43 IV) with knee dislocation were randomly divided into the remnant-preserved group and the simple reconstruction group. Patients underwent two-stage reconstruction, including the reconstruction of collateral ligament in phase I and the reconstruction of ACL/PCL in phase II (12 weeks after phase I). Grafts were harvested from the semitendinosus and gracilis tendons from both lower limbs. After the surgery, the joint flexion and extension, bone tunnel and ligament healing, and joint stability were evaluated.

Results

After the surgery, the lateral stability recovered in all patients, and X-ray revealed a good position of bone tunnel. Follow-up was performed at 12 months postoperatively and ranged from 24 to 91 months. At the final follow-up, knee flexion angle, IKDC, Lysholm, and Tegner scores were all higher in both groups compared to the preoperative period. Notably, the remnant-preserved group showed superior results in these parameters compared to the simple reconstruction group. There was statistical significance between the two groups in terms of the Lachman test.

The knee function was well recovered after two-stage ligament reconstruction with remnant preservation.

Reference:

Ma, W., Yang, Y. & Ha, X. Two-stage ligament reconstruction with remnant preservation as treatment of knee dislocation. BMC Surg 23, 371 (2023). https://doi.org/10.1186/s12893-023-02271-5

Keywords:

Two-stage, ligament, reconstruction, with, remnant, preservation, may, preserve, function, knee dislocation, BMC Surgery, Ma, W., Yang, Y. & Ha, X.

Powered by WPeMatico

ACOG recommends More Testing During Pregnancy prompted by Rising Syphilis Cases

Syphilis numbers are on the rise in Tennessee: In women, the number of cases has risen 311%, from 290 cases in 2017 to 1,191 in 2022.

“Part of the issue is the lack of timely testing in pregnancy and adequate treatment during pregnancy,” said Soha Patel, MD, MSPH, assistant professor in the department of Obstetrics and Gynecology. “Another issue is regarding the shortage of the first line injectable penicillin for treatment of syphilis.”

Syphilis is a sexually transmitted infection (STI) passed through unprotected oral, anal or vaginal sex, and can be detected through a blood test. When found and treated early with antibiotics, syphilis is curable. Untreated syphilis can cause deafness, blindness and irreversible heart and brain damage. Syphilis can also be passed from mother to unborn baby at any time.

“We are seeing babies with syphilis and syphilis exposure, and it could have a lifelong effect on the child if not treated, including mental retardation, deafness, blindness, abnormal detention, bony abnormalities, growth problems and more,” said Walter Dehority, MD, MSc, associate professor in the department of Pediatrics, division of Infectious Diseases. “We treat congenital syphilis with 10 days of IV penicillin. Many infants born to women with untreated syphilis will require x-rays of the bones, an eye exam, a lumbar puncture and blood work just to evaluate for congenital syphilis infection, even if they are not treated.”

According to the Tennessee Department of Health, syphilis increases risk of preterm birth and is a major cause of stillbirth: Up to 40% of babies of mothers with untreated syphilis are stillborn or die in infancy.

The American College of Obstetrician and Gynecologists (ACOG) updated their guidance-which previously recommended third trimester testing only for those in communities with high syphilis rates or have been at risk during pregnancy-to three screenings for every pregnant person.

“Per ACOG’s most recent recommendation, because of the rapidly increasing rates of congenital syphilis, prenatal providers should screen all pregnant individuals for syphilis at the first prenatal care visit, followed by universal rescreening during the third trimester and at birth,” Patel said.

VUMC is in alignment with these recommendations and has rolled out the new requirement in inpatient and outpatient settings.

“Timely diagnosis and treatment are key to reducing syphilis rates, and yet we are currently facing several challenges, including treatment shortages, lack of access to prenatal care, and the stigma that surrounds sexually transmitted infections,” said Christopher Zahn, MD, FACOG, interim ACOG CEO and chief of clinical practice and health equity and quality. “Congenital syphilis can have devastating effects. We know that a majority of cases can be prevented, so additional routine screening during pregnancy is one important step that clinicians can take that could potentially be lifesaving.”

Powered by WPeMatico

Novel self-powered sensor could make MRIs more efficient, claims research

MRI scans are commonly used to diagnose a variety of conditions, anything from liver disease to brain tumors. But, as anyone who has been through one knows, patients must remain completely still to avoid blurring the images and requiring a new scan. A prototype device described in ACS Sensors could change that. The self-powered sensor detects movement and shuts down an MRI scan in real time, improving the process for patients and technicians.

During an MRI scan, a patient must stay entirely still for several minutes at a time, otherwise “motion artifacts” could appear and blur the final image. To ensure a clear picture, patient movement needs to be identified as soon as it happens, allowing the scan to stop and for the technician to take a new one. Motion tracking could be achieved using sensors embedded into the MRI table; however, magnetic materials can’t be used because metals interfere with the MRI technology itself. One technology that’s well-suited for this unique situation, and avoids the need for metal or magnetic components, is the triboelectric nanogenerator (TENG), which powers itself using static electricity generated by friction between polymers. So, Li Tao, Zhiyi Wu and colleagues wanted to design a TENG-based sensor that could be incorporated into an MRI machine to help prevent motion artifacts.

The team created the TENG by sandwiching two layers of plastic film painted with graphite-based conductive ink around a central layer of silicone. These materials were specifically chosen as they would not interfere with an MRI scan. When pressed together, electrostatic charges from the plastic film moved to the conductive ink, creating a current that could then flow out through a wire.

This sensor was incorporated into an MRI table designed to lay under a patient’s head. In tests, when a person turned their head from side to side or raised it off the table, the sensor detected these movements and transmitted a signal to a computer. Then, an audible alert played, a pop-up window on the technician’s computer appeared and the MRI scan ceased. The researchers say that this work could help make MRI scans more efficient and less frustrating for patients and technicians alike by producing better images during a single procedure.

Reference:

Yiran Hu, Chengcheng Han, Xiaoqing Huo, Xiaole Cao, Yongyang Chen, Zhi Cao, Yong Xu, Li Tao, and Zhiyi Wu, ACS Sensors 2024 9 (5), 2614-2621, DOI: 10.1021/acssensors.4c00319.

Powered by WPeMatico

Applying tension to transcervical Foley balloon fails to reduce delivery time or improve secondary outcomes: Study

Recent research paper aimed to investigate the impact of applying tension to a transcervical Foley balloon on delivery time in term nulliparous patients undergoing labor induction. A cluster randomized clinical trial was conducted, including 279 term nulliparous women undergoing labor induction with transcervical Foley balloon placement. Participants were assigned to either the tension or no-tension group on a randomized, weekly basis. The primary outcome measured was the time from initial Foley balloon insertion to delivery, with secondary outcomes including cesarean delivery rates, peripartum infection, and neonatal intensive care unit admission.

Study Findings

The study found that applying tension to a transcervical Foley balloon did not significantly reduce delivery time or improve secondary outcomes. The median time from Foley placement to delivery was 1,596 minutes for the tension group and 1,621 minutes for the no-tension group, with no significant differences in secondary outcomes such as cesarean delivery rates, peripartum infection, and neonatal intensive care unit admission.

Research Methodology

The research methodology included a pragmatic cluster randomized clinical trial, with a waiver of informed consent, randomization based on weekly clusters, and inclusion and exclusion criteria to ensure the study’s robustness and generalizability. The study’s large sample size of 279 participants increased the ability to detect significant differences in outcomes between the tension and no-tension groups compared with prior smaller studies. The study also examined a comprehensive range of primary and secondary outcomes in the intention-to-treat and per-protocol populations, providing valuable insights.

Study Limitations

However, the study had limitations, including being conducted at a single institution and not allowing blinding of clinicians or patients to the intervention. Furthermore, the study did not investigate the effects of other variations on Foley balloon use, such as the type of balloon, the method of placement, or the use of concomitant ripening agents, which may influence the effectiveness of the method for cervical ripening and labor induction.

In conclusion, the study found no significant difference in delivery times or secondary outcomes between the tension and no-tension groups when using a transcervical Foley balloon for cervical ripening in nulliparous women undergoing labor induction. The findings suggest that applying tension to the transcervical Foley balloon may not have a clear advantage or disadvantage. The paper also highlighted the need for further research to identify the most effective strategies for cervical ripening and labor induction, considering the high rate of labor induction in the United States and the significant variation in clinical practice.

Key Points –

– The study findings revealed that applying tension to a transcervical Foley balloon did not significantly reduce delivery time or improve secondary outcomes. The median time from Foley placement to delivery was 1,596 minutes for the tension group and 1,621 minutes for the no-tension group, with no significant differences in secondary outcomes such as cesarean delivery rates, peripartum infection, and neonatal intensive care unit admission.

– The research methodology included a pragmatic cluster randomized clinical trial, with a waiver of informed consent, randomization based on weekly clusters, and inclusion and exclusion criteria to ensure the study’s robustness and generalizability. The study’s large sample size of 279 participants increased the ability to detect significant differences in outcomes between the tension and no-tension groups compared with prior smaller studies. The study also examined a comprehensive range of primary and secondary outcomes in the intention-to-treat and per-protocol populations, providing valuable insights. However, the study had limitations, including being conducted at a single institution and not allowing blinding of clinicians or patients to the intervention. Furthermore, the study did not investigate the effects of other variations on Foley balloon use, such as the type of balloon, the method of placement, or the use of concomitant ripening agents, which may influence the effectiveness of the method for cervical ripening and labor induction.

Reference –

Benson, Meagan DO; Younes, Lena MD; Watson, Alisha MD; Saade, George R. MD; Saad, Antonio F. MD. Applying Tension to the Transcervical Foley Balloon and Delivery Times in Term Nulliparous Women Undergoing Induction of Labor: A Randomized Controlled Trial. Obstetrics & Gynecology 143(5):p 670-676, May 2024. | DOI: 10.1097/AOG.0000000000005546

Powered by WPeMatico