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Gynecology & Obstetrics (all articles)

Clinical Trial Follow-up: Antenatal corticosteroids not associated with adverse neurodevelopmental outcomes in late preterm births – JAMA

2 May, 2024 | 23:25h | UTC

Study Design and Population:

This research involved a prospective follow-up study of a multicenter randomized clinical trial, specifically focusing on children aged 6 years or older whose birthing parents were enrolled in the Antenatal Late Preterm Steroids (ALPS) trial. The trial initially examined the impact of administering 12 milligrams of intramuscular betamethasone, given twice 24 hours apart, on late preterm infants (34-36 completed weeks). The follow-up study involved 949 children from 13 centers in the Maternal-Fetal Medicine Units (MFMU) Network, assessed for neurodevelopmental outcomes.

 

Main Findings:

The primary outcome measured was the General Conceptual Ability score less than 85 on the Differential Ability Scales, 2nd Edition (DAS-II). Results showed no statistically significant differences between the betamethasone group (17.1%) and the placebo group (18.5%) in achieving this score. Secondary outcomes related to motor function and social responsiveness also showed no significant differences between the groups. Sensitivity analyses further confirmed these findings, suggesting that the administration of betamethasone did not adversely affect neurodevelopmental outcomes at age 6 or older.

 

Implications for Practice:

These findings support the continued use of antenatal corticosteroids for improving short-term neonatal respiratory outcomes in late preterm deliveries without concern for long-term neurodevelopmental harm. Clinicians can consider these results reassuring, as the study effectively dispels earlier concerns about potential negative long-term effects related to neurodevelopment from antenatal steroid use in late preterm infants.

 

Reference (link to abstract – $ for full-text):

Reference: Cynthia Gyamfi-Bannerman et al. (2024). Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids The ALPS Follow-Up Study. JAMA, Published online April 24, 2024. DOI: 10.1001/jama.2024.4303

 


USPSTF Guideline: Biennial screening mammography recommended for women aged 40-74 to reduce breast cancer morbidity and mortality

1 May, 2024 | 21:45h | UTC

Study Design and Population:

The US Preventive Services Task Force (USPSTF) performed a systematic review and collaborated on modeling studies to evaluate the effectiveness of various mammography-based breast cancer screening strategies. This assessment included factors such as age of initiation and cessation of screening, screening intervals, modalities, and the use of supplemental imaging. The population studied consisted of cisgender women and all other persons assigned female at birth who are 40 years or older and at average risk of breast cancer.

 

Main Findings:

The USPSTF concludes with moderate certainty that biennial screening mammography for women aged 40 to 74 years provides a moderate net benefit in reducing the incidence of and progression to advanced breast cancer, as well as in decreasing breast cancer morbidity and mortality. However, the evidence is insufficient to assess the benefits and harms of mammography screening in women aged 75 and older, as well as the use of supplemental screening with ultrasound or MRI in women with dense breasts.

 

Implications for Practice:

Based on these findings, the USPSTF recommends biennial screening mammography for women aged 40 to 74 years. This recommendation aims to optimize breast cancer outcomes while considering the balance of benefits and harms of screening. There is a need for further research to clarify the benefits and risks associated with mammography in women older than 75 and for those with dense breasts considering supplemental screening.

 

Commentary on X (thread – click for more)

 

Reference (link to free full-text):

Screening for Breast Cancer US Preventive Services Task Force Recommendation Statement. JAMA. Published online April 30, 2024. doi:10.1001/jama.2024.5534

 


RCT: Radiation therapy alone superior to chemoradiation in low-grade localized endometrial cancer recurrences

1 May, 2024 | 21:41h | UTC

This randomized clinical trial assessed the effectiveness of radiation therapy alone versus concurrent chemoradiation in treating localized recurrences of endometrial cancer. Conducted from February 2008 to August 2020, the study involved 165 patients who were randomized to receive either radiation therapy alone or chemoradiation with weekly cisplatin. Findings indicate that radiation therapy alone resulted in longer progression-free survival (PFS) compared to chemoradiation, with a median PFS not reached for radiation alone versus 73 months for chemoradiation. Additionally, radiation therapy demonstrated lower rates of acute toxicity. The study concluded that for patients with low-grade and primarily vaginal recurrences, radiation therapy alone is the preferable treatment option, offering excellent outcomes without the added toxicity of chemotherapy.

 

Reference (link to abstract – $ for full-text):

Ann H. Klopp et al. (Year). Radiation Therapy With or Without Cisplatin for Local Recurrences of Endometrial Cancer: Results From an NRG Oncology/GOG Prospective Randomized Multicenter Clinical Trial. Journal of Clinical Oncology. DOI: 10.1200/JCO.23.01279

 


RCT: Aspirin fails to improve invasive disease-free survival in breast cancer patients

1 May, 2024 | 21:37h | UTC

This randomized clinical trial assessed the efficacy of daily aspirin (300 mg) as adjuvant therapy in reducing breast cancer recurrence among 3020 participants with high-risk nonmetastatic breast cancer across the United States and Canada. The study, which followed participants for a median of 33.8 months, found no significant benefit of aspirin on invasive disease-free survival or overall survival, with the hazard ratio for disease-free survival being 1.27 (95% CI, 0.99-1.63; P = .06) and for overall survival 1.19 (95% CI, 0.82-1.72). Given these findings, aspirin is not recommended as an adjuvant treatment for breast cancer, challenging earlier observational data that suggested a potential survival benefit in breast cancer survivors. The trial was concluded early due to the lack of observed benefits, with adverse event rates being similar in both the aspirin and placebo groups.

 

Commentary on X:

 

Reference (link to abstract – $ for full-text):

Wendy Y. Chen et al. (2024). Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA, Published online April 29, 2024. doi:10.1001/jama.2024.4840

 


Cohort Study: No increased risk of autism, ADHD, or intellectual disability from acetaminophen use in pregnancy

29 Apr, 2024 | 12:34h | UTC

This cohort study investigated the association between acetaminophen use during pregnancy and the risk of autism, ADHD, and intellectual disability in children. The study utilized a population-based sample of nearly 2.5 million Swedish children born between 1995 and 2019, with data analyzed up to 2021. Initial findings without sibling controls suggested a marginal increase in the risks of autism and ADHD. However, sibling control analyses, which help adjust for familial confounding, showed no significant associations (HR for autism and ADHD at 0.98, and intellectual disability at 1.01). These results imply that earlier observed risks might be due to unaccounted familial factors, not acetaminophen exposure.

 

Reference (link to abstract – $ for full-text):

Viktor H. Ahlqvist et al. (2024). Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA, 331(14), 1205-1214. DOI: 10.1001/jama.2024.3172

 


Observational Study: Synergistic effects of early menopause and vascular risk on cognitive decline in postmenopausal women

27 Apr, 2024 | 18:20h | UTC

Study Design and Population:
This study analyzed data from 8,360 postmenopausal women and an equal number of age-matched male participants from the Canadian Longitudinal Study on Aging. Researchers assessed the independent and combined effects of age at menopause, vascular risk factors, and history of hormone therapy on cognitive outcomes. Participants’ cognitive function was measured using a global cognitive composite at baseline and again at a 3-year follow-up.

 

Main Findings:
The study found a synergistic interaction between early menopause (ages 35-48) and high vascular risk, significantly associated with lower cognitive scores at follow-up. Specifically, earlier menopause combined with higher vascular risk resulted in greater cognitive decline, compared to their individual effects. Notably, hormone therapy did not modify this association. This pattern was not observed in female participants with average or later menopause ages, nor in the age-matched male cohort.

 

Implications for Practice:
The findings underscore the importance of considering both endocrine and vascular health as predictive markers in dementia prevention strategies, particularly for women. These results suggest that women with early menopause and vascular risk factors should be closely monitored to mitigate their higher risk of cognitive impairment.

 

Reference (link to abstract – $ for full-text):

Alexander, M.W. et al. (2024). Associations Between Age at Menopause, Vascular Risk, and 3-Year Cognitive Change in the Canadian Longitudinal Study on Aging. Neurology, 102(9), 1-12. DOI: https://doi.org/10.1212/WNL.0000000000209298.


RCT: Free Access to Water vs. Fasting Pre-Cesarean Reduces Vomiting and Increases Maternal Satisfaction

25 Mar, 2024 | 11:17h | UTC

Study Design and Population: This randomized controlled trial was carried out at the Obstetric Unit, Universiti Malaya Medical Center from October 2020 to May 2022. A total of 504 women scheduled for planned cesarean delivery under spinal anesthesia were randomized into two groups: 252 were allowed free access to water up until being called to the operating theater, and 252 were required to fast from midnight before the procedure. The study primarily aimed to evaluate the effects of these preoperative oral intake policies on perioperative vomiting and maternal satisfaction.

Main Findings: The results demonstrated significant benefits for the group with free access to water. Specifically, perioperative vomiting was observed in 3.6% of women with water access compared to 9.5% of those fasting, indicating a relative risk reduction. Maternal satisfaction scores were notably higher in the water access group, with median scores of 9 versus 5 for the fasting group. Additional findings included lower reports of thirst, fewer instances of preoperative intravenous hydration, reduced ketone presence in urine, and a lower average number of vasopressor doses needed. Significantly, 95.2% of participants in the water access group would recommend their regimen to a friend, compared to only 39.7% in the fasting group.

Implications for Practice: Allowing free access to water up until the time of surgery for women scheduled for cesarean delivery under spinal anesthesia significantly reduces the risk of perioperative vomiting and improves maternal satisfaction, without adversely affecting post-cesarean recovery or neonatal outcomes. These findings support revising current preoperative fasting guidelines to improve patient experience and potentially enhance clinical outcomes.

Reference: Ng, Y. L., Segaran, S., Yim, C. C. W., Lim, B. K., Hamdan, M., Gan, F., & Tan, P. C. (2024). Preoperative free access to water compared to fasting for planned cesarean under spinal anesthesia: A randomized controlled trial. American Journal of Obstetrics and Gynecology, S0002-9378(24)00447-2. DOI: 10.1016/j.ajog.2024.03.018.


Cohort Study: Elevated autism spectrum disorder risk in children exposed to valproate during pregnancy

21 Mar, 2024 | 13:16h | UTC

Study Design and Population: This cohort study utilized two health care utilization databases in the United States, covering the period from 2000 to 2020, to investigate the association between prenatal exposure to antiseizure medications and the risk of autism spectrum disorder (ASD) in children. The study compared children exposed to topiramate, valproate, or lamotrigine during the second half of pregnancy to those unexposed to any antiseizure medication, specifically focusing on a population-based cohort of pregnant women and their offspring.

Main Findings: The cumulative incidence of ASD at 8 years of age was found to be higher in children exposed to these medications compared to the general population. Notably, the incidence was 6.2% for children exposed to topiramate, 10.5% for valproate, and 4.1% for lamotrigine among children born to mothers with epilepsy. However, after adjusting for potential confounders, the increased risk of ASD remained significant only for valproate exposure, with a hazard ratio of 2.67, indicating a substantial risk compared to unexposed children. Topiramate and lamotrigine showed no significant increase in risk after adjustment.

Implications for Practice: The findings underscore the importance of carefully considering the risks and benefits of using antiseizure medications during pregnancy. Specifically, valproate should be used with caution, if at all, given its significant association with an increased risk of ASD in offspring. This study supports the need for targeted counseling and monitoring of pregnant women with epilepsy and highlights the necessity for further research to fully understand the neurodevelopmental impact of prenatal exposure to antiseizure medications.

Reference: Sonia Hernández-Díaz et al. (2024). Cohort Study: Assessing Autism Spectrum Disorder Risk in Children Exposed to Antiseizure Medications During Pregnancy. N Engl J Med, 390(13), 1069-1079. DOI: 10.1056/NEJMoa2309359. Access the study here: [Link]


Caring for two in the ICU: pharmacologic management of pregnancy-related complications

7 Aug, 2023 | 14:31h | UTC

Caring for two in the ICU: Pharmacologic management of pregnancy-related complications – Pharmacotherapy (free for a limited period)

 


USPSTF | Reaffirming the importance of folic acid to all women planning to or who could become pregnant to prevent neural tube defects

4 Aug, 2023 | 12:15h | UTC

Folic Acid Supplementation to Prevent Neural Tube Defects: US Preventive Services Task Force Reaffirmation Recommendation Statement – JAMA

Evidence Report: Folic Acid Supplementation to Prevent Neural Tube Defects: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force – JAMA

Patient Page: Folic Acid to Prevent Neural Tube Defects – JAMA

 

Commentary on Twitter

 


RCT | Mammography screening with AI reduces workload by 44.3% without loss in detection efficacy

4 Aug, 2023 | 12:13h | UTC

Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study – The Lancet Oncology (link to abstract – $ for full-text)

News Release: First randomized trial finds AI-supported mammography screening is safe and almost halves radiologist workload – Lancet

Commentaries:

Large Mammography Study Shows Significant Benefits with AI-Aided Screening – Diagnostic Imaging

Expert reaction to interim safety analysis of randomised trial on AI-supported mammography screening – Science Media Centre

 


M-A | Antenatal corticosteroid exposure linked to negative outcomes in term-born infants

4 Aug, 2023 | 11:59h | UTC

The proportions of term or late preterm births after exposure to early antenatal corticosteroids, and outcomes: systematic review and meta-analysis of 1.6 million infants – The BMJ

Related Study: Association between antenatal corticosteroids and risk of serious infection in children: nationwide cohort study – The BMJ

Editorial: Antenatal corticosteroids and longer term outcomes – The BMJ

News Releases:

New studies shed more light on potential risks of antenatal steroids – BMJ Newsroom

Researchers find drugs that reduce infant death may lead to long-term health issues – McMaster University

 


Cohort Study | Antenatal corticosteroid exposure associated with increased incidence of pediatric serious infection

4 Aug, 2023 | 11:57h | UTC

Association between antenatal corticosteroids and risk of serious infection in children: nationwide cohort study – The BMJ

Related Study: The proportions of term or late preterm births after exposure to early antenatal corticosteroids, and outcomes: systematic review and meta-analysis of 1.6 million infants – The BMJ

Editorial: Antenatal corticosteroids and longer term outcomes – The BMJ

 


M-A | Exploring perinatal interventions and their impact on severe intraventricular hemorrhage in preterm neonates

4 Aug, 2023 | 11:56h | UTC

Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates: A Systematic Review and Meta-analysis – JAMA Network Open

 

Commentary on Twitter

 


Review | Atypical hyperplasia of the breast: Clinical cases and management strategies

3 Aug, 2023 | 13:07h | UTC

Atypical hyperplasia of the breast: Clinical cases and management strategies – Cleveland Clinic Journal of Medicine

 


BSH guideline for anticoagulant management of pregnant individuals with mechanical heart valves

2 Aug, 2023 | 14:01h | UTC

British Society for Haematology guideline for anticoagulant management of pregnant individuals with mechanical heart valves – British Journal of Haematology

 


RCT | Maternal egg intake in early neonatal period does not impact infant egg allergy risk

2 Aug, 2023 | 13:47h | UTC

Effect of Maternal Egg Intake During the Early Neonatal Period and Risk of Infant Egg Allergy at 12 Months Among Breastfeeding Mothers: A Randomized Clinical Trial – JAMA Network Open

See also: Visual Abstract

 


RCT | Early vs. delayed intrauterine balloon tamponade: no difference in severe postpartum hemorrhage

2 Aug, 2023 | 13:42h | UTC

Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial – The American Journal of Obstetrics and Gynecology (link to abstract  – $ for full-text)

 


Cohort Study | History of pregnancy loss linked to higher MI and stroke risk in women, but not in male partners

1 Aug, 2023 | 14:13h | UTC

Pregnancy Loss and the Risk of Myocardial Infarction, Stroke, and All‐Cause Mortality: A Nationwide Partner Comparison Cohort Study – Journal of the American Heart Association

Commentary: Pregnancy Loss Linked to Increased Risk of Heart Attack in Women, But Not Male Partners – HCP Live

 


RCT | Cervical pessary fails to prevent preterm birth in short cervix singleton pregnancies

27 Jul, 2023 | 13:06h | UTC

Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: The Vexing Problem of Preterm Birth Prevention – JAMA (free for a limited period)

See also: Visual Abstract

News Release: Cervical pessary no more effective than usual care in preventing preterm birth risk – NIH News Releases

 


RCT | Zuranolone, a potential rapid-acting oral treatment for severe postpartum depression

27 Jul, 2023 | 13:00h | UTC

Zuranolone for the Treatment of Postpartum Depression – American Journal of Psychiatry (link to abstract – $ for full-text)

Commentary: Postpartum Depression Pill Zuralonone Shows Promise in Women With Severe Symptoms – Psychiatric News Alert

Related: RCT | Zuranolone outperforms placebo in major depressive disorder treatment

 


Consensus Paper | Urinary tract infections in pregnant individuals

25 Jul, 2023 | 13:53h | UTC

Urinary Tract Infections in Pregnant Individuals – Obstetrics & Gynecology

 


Key factors associated with quality of postnatal care: a pooled analysis of 23 countries

25 Jul, 2023 | 13:50h | UTC

Key factors associated with quality of postnatal care: a pooled analysis of 23 countries – eClinicalMedicine

 


Cohort Study | The role of antiphospholipid syndrome and specific antibodies in predicting SLE pregnancy complications

25 Jul, 2023 | 13:44h | UTC

Pregnancy outcomes in 1869 pregnancies in a large cohort from the Spanish Society of Rheumatology Lupus Register (RELESSER) – Seminars in Arthritis and Rheumatism (link to abstract – $ for full-text)

Commentary: SLE and Pregnancy Outcomes – RheumNow

 


Systematic Review | Post-mastectomy RT likely lowers recurrence and improves survival in early breast cancer with 1-3 positive nodes

25 Jul, 2023 | 13:34h | UTC

Post‐mastectomy radiotherapy for women with early breast cancer and one to three positive lymph nodes – Cochrane Library

Summary: Is X-ray treatment (radiotherapy) after removal of breast tissue (mastectomy) better than no X-ray treatment in women diagnosed with breast cancer that has spread to one to three armpit lymph nodes? – Cochrane Library

 


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