Maternal-fetal Medicine
Cohort Study: High Rate of Preventable Adverse Events in Surgical Inpatients
16 Nov, 2024 | 17:29h | UTCBackground: Adverse events during hospital admissions, particularly in surgical settings, remain a significant cause of patient harm despite efforts to improve patient safety since the “To Err is Human” report. Advances in surgical techniques and patient care necessitate an updated assessment of the current state of perioperative safety.
Objective: To estimate the frequency, severity, and preventability of adverse events associated with perioperative care in surgical inpatients and to identify the settings and healthcare professionals involved.
Methods: A multicenter retrospective cohort study was conducted across 11 US hospitals in Massachusetts. A weighted random sample of 1,009 patients was selected from 64,121 adults admitted for surgery in 2018. Trained nurses reviewed electronic health records to identify adverse events, which were then adjudicated by physicians. Adverse events were classified by type, severity, preventability, setting, and professions involved.
Results: Adverse events occurred in 38.0% of patients (95% CI, 32.6–43.4%), with major adverse events in 15.9% (12.7–19.0%). Among 593 adverse events identified, 59.5% were potentially preventable, and 20.7% were definitely or probably preventable. The most common events were surgery-related (49.3%), adverse drug events (26.6%), healthcare-associated infections (12.4%), and patient care events (11.2%). Adverse events most frequently occurred in general care units (48.8%) and involved attending physicians (89.5%) and nurses (58.9%).
Conclusions: More than one-third of surgical inpatients experienced adverse events, with nearly half classified as major and most potentially preventable. These findings highlight the critical need for ongoing improvement in patient safety throughout perioperative care involving all healthcare professionals.
Implications for Practice: Healthcare providers should enhance patient safety protocols across all perioperative settings, not just in operating rooms. Emphasis should be placed on preventing surgery-related complications, adverse drug events, and healthcare-associated infections by fostering teamwork and continuous monitoring.
Study Strengths and Limitations: Strengths include a comprehensive review of medical records and systematic classification of adverse events by trained professionals. Limitations involve the study’s confinement to Massachusetts hospitals in 2018, potential variability in documentation practices, and limited sample size affecting generalizability and specialty-specific estimates.
Future Research: Further studies are needed to assess adverse event rates in diverse geographic locations and healthcare systems, explore effective interventions to reduce preventable harm, and evaluate long-term trends in surgical patient safety.
Cohort Study: Prenatal Exposure to Buprenorphine with Naloxone Appears Safe and More Effective than Buprenorphine Alone for Neonates and Mothers – JAMA
18 Aug, 2024 | 18:06h | UTCStudy Design and Population: This population-based cohort study used healthcare data from Medicaid-insured pregnancies in the US between 2000 and 2018. The study included 8,695 pregnant individuals linked to their liveborn infants. Participants were exposed to either buprenorphine combined with naloxone or buprenorphine alone during the first trimester.
Main Findings: The study found that prenatal exposure to buprenorphine with naloxone was associated with a lower risk of neonatal abstinence syndrome (37.4% vs 55.8%) and modest reductions in neonatal intensive care unit admission (30.6% vs 34.9%) and small for gestational age (10.0% vs 12.4%) compared to buprenorphine alone. No significant differences were observed for congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery.
Implications for Practice: These findings suggest that buprenorphine combined with naloxone is a safe and potentially preferable option for treating opioid use disorder during pregnancy, providing more flexibility in treatment choices for pregnant individuals.
Systematic Review: Uncertain Impact of Vitamin D Supplementation During Pregnancy on Key Maternal and Neonatal Outcomes – Cochrane Database Syst Rev
11 Aug, 2024 | 12:42h | UTCStudy Design and Population: This Cochrane systematic review evaluates the effects of vitamin D supplementation alone or in combination with calcium and other vitamins/minerals during pregnancy. The analysis included 10 randomized controlled trials (RCTs) with a total of 2,313 pregnant women. The review excluded 20 studies from previous versions due to trustworthiness concerns and incorporated one new study.
Main Findings: The evidence regarding vitamin D supplementation alone was very uncertain for its impact on pre-eclampsia, gestational diabetes, preterm birth, and nephritic syndrome. There is low-certainty evidence suggesting that vitamin D may reduce the risk of severe postpartum hemorrhage and low birthweight, though the possibility of increased risk cannot be excluded. Supplementation with vitamin D plus calcium showed very uncertain effects on preterm birth and low birthweight, with no conclusive data on pre-eclampsia, gestational diabetes, or maternal adverse events. The combination of vitamin D, calcium, and other vitamins/minerals also yielded very uncertain evidence for all outcomes examined.
Implications for Practice: The current evidence does not provide strong support for routine vitamin D supplementation during pregnancy due to the low and very uncertain evidence on key outcomes. Further high-quality RCTs are needed to better understand the effects, particularly concerning maternal adverse events and neonatal health.
Cohort Studies: Metformin During Early Pregnancy or Spermatogenesis is Safe Regarding Congenital Malformation Risks – Ann Intern Med
10 Aug, 2024 | 20:05h | UTCStudy Design and Population: Two observational cohort studies assessed the safety of metformin, focusing on early pregnancy and paternal use during spermatogenesis. The first study involved 12,489 pregnant women with pregestational type 2 diabetes, comparing those on insulin monotherapy to those on insulin plus metformin. The second study analyzed 383,851 live births in Israel, examining the impact of paternal metformin use during spermatogenesis on congenital malformations in newborns.
Main Findings: The first study found no significant increase in the risk of nonlive births when continuing metformin in early pregnancy compared to switching to insulin monotherapy. The risk of congenital malformations was also comparable between the two groups. The second study showed that paternal metformin use in monotherapy did not raise the risk of major congenital malformations, though a slight risk increase was observed with metformin in polytherapy, potentially due to underlying cardiometabolic conditions.
Implications for Practice: These findings suggest that metformin use, either during early pregnancy or spermatogenesis, poses minimal risk for congenital malformations. However, clinicians should consider the overall cardiometabolic profile and diabetes management when prescribing metformin, especially in combination with other antidiabetic medications.
References:
AAN updated practice guidelines for epilepsy and pregnancy – Neurology
27 May, 2024 | 20:23h | UTCIntroduction:
The American Academy of Neurology (AAN), the American Epilepsy Society (AES), and the Society for Maternal-Fetal Medicine (SMFM) have published a comprehensive guideline focusing on the management of epilepsy in individuals of childbearing potential. This guideline addresses the use of antiseizure medications (ASMs) and the impact of folic acid supplementation on major congenital malformations (MCMs), perinatal outcomes, and neurodevelopmental outcomes.
Key Points:
- Optimizing ASM Therapy Preconceptionally: Clinicians should recommend ASMs and doses that optimize both seizure control and fetal outcomes should pregnancy occur, ideally starting this process preconceptionally.
- Minimizing Convulsive Seizures During Pregnancy: It is crucial to minimize convulsive seizures in pregnant individuals to reduce risks to both the parent and the fetus.
- Monitoring and Adjusting ASM Levels: ASM levels should be monitored throughout pregnancy, and doses should be adjusted based on serum levels and seizure control.
- Preferred ASMs for Pregnancy: Lamotrigine, levetiracetam, and oxcarbazepine are recommended when appropriate, as they are associated with lower risks of MCMs compared to other ASMs.
- Avoiding Certain ASMs: Valproic acid should be avoided to minimize risks of MCMs, neural tube defects, and poor neurodevelopmental outcomes. Topiramate should also be avoided due to risks of offspring being born small for gestational age.
- Folic Acid Supplementation: At least 0.4 mg of folic acid should be prescribed daily preconceptionally and during pregnancy to decrease the risk of neural tube defects and possibly improve neurodevelopmental outcomes.
- Counseling on Risks and Monitoring: Clinicians must counsel patients on the potential risks associated with different ASMs and ensure regular fetal screenings to detect congenital malformations early.
Conclusion:
These guidelines provide essential, evidence-based recommendations for managing epilepsy in individuals of childbearing potential, emphasizing the importance of preconception planning, careful medication selection, and ongoing monitoring to optimize both maternal and fetal health outcomes.
Guideline Reference (link to free full-text):
Cohort Study: Prenatal opioid exposure linked to modest increase in neuropsychiatric disorders – The BMJ
25 May, 2024 | 19:50h | UTCThis nationwide birth cohort study from South Korea investigated the impact of prenatal opioid exposure on the risk of neuropsychiatric disorders among children. The study followed 3,128,571 infants born between 2010 and 2017 until the end of 2020. Researchers found that infants exposed to opioids prenatally showed a slightly increased risk of developing neuropsychiatric disorders, including mood disorders, attention deficit hyperactivity disorder, and intellectual disability. The increased risk was more pronounced with higher opioid doses, longer duration of use, and exposure during the first trimester of pregnancy. However, this association was not significant in sibling comparison cohorts, indicating a modest overall clinical impact. The study emphasizes the need for cautious interpretation due to its observational design and the specific conditions under which risk increases.
Reference (link to free full-text):
Cohort Study: First-trimester screening protocol achieves higher detection rates for preterm preeclampsia in nulliparous women – Hypertension
25 May, 2024 | 18:53h | UTCThis study aimed to evaluate the effectiveness of the Fetal Medicine Foundation’s (FMF) first-trimester screening protocol for predicting preterm preeclampsia in nulliparous women. A prospective multicenter cohort study was conducted involving 7554 nulliparous women, recruited at 11 to 14 weeks of pregnancy. Screening included assessing maternal characteristics, mean arterial blood pressure, pregnancy-associated plasma protein A (PAPP-A), placental growth factor (PlGF), and uterine artery pulsatility index. The risk assessment was performed by a third party, blinded to pregnancy outcomes, using receiver operating characteristic curves. Of the participants, 7325 remained eligible beyond 20 weeks of gestation. Among these, 65 (0.9%) developed preterm preeclampsia and 22 (0.3%) early-onset preeclampsia. The FMF screening test achieved a detection rate of 63.1% for preterm and 77.3% for early-onset preeclampsia at a false-positive rate of 15.8%. In comparison, using criteria from the American College of Obstetricians and Gynecologists, the detection rates were 61.5% and 59.1%, respectively, but at a higher false-positive rate of 34.3%. The findings suggest that the FMF screening test is a more accurate and efficient method for predicting preterm preeclampsia in the first trimester among nulliparous women.
Reference (link to abstract – $ for full-text):
Clinical Trial Follow-up: Antenatal corticosteroids not associated with adverse neurodevelopmental outcomes in late preterm births – JAMA
2 May, 2024 | 23:25h | UTCStudy 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):
Cohort Study: No increased risk of autism, ADHD, or intellectual disability from acetaminophen use in pregnancy
29 Apr, 2024 | 12:34h | UTCThis 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):
RCT: Free Access to Water vs. Fasting Pre-Cesarean Reduces Vomiting and Increases Maternal Satisfaction
25 Mar, 2024 | 11:17h | UTCStudy 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.
Cohort Study: Elevated autism spectrum disorder risk in children exposed to valproate during pregnancy
21 Mar, 2024 | 13:16h | UTCStudy 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 | UTCCaring 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 | UTCEvidence 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
2023 Recommendation Statement from the USPSTF: all persons planning to or who could become pregnant should take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid (A recommendation). https://t.co/gdavbWyZZ7 pic.twitter.com/2PAjb0OCBO
— JAMA (@JAMA_current) August 1, 2023
M-A | Antenatal corticosteroid exposure linked to negative outcomes in term-born infants
4 Aug, 2023 | 11:59h | UTCRelated 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
Cohort Study | Antenatal corticosteroid exposure associated with increased incidence of pediatric serious infection
4 Aug, 2023 | 11:57h | UTCEditorial: 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
Commentary on Twitter
A meta-analysis by @DrAbdulRazak_MD & colleagues on perinatal interventions are associated with a reduction or increase of IVH and PVL #EBNEOalerts #neoEBM #neotwitter https://t.co/SPzNHwy3HD pic.twitter.com/KDQBSYZjdq
— Evidence-Based Neo (@EBNEO) April 26, 2023
BSH guideline for anticoagulant management of pregnant individuals with mechanical heart valves
2 Aug, 2023 | 14:01h | UTC
RCT | Maternal egg intake in early neonatal period does not impact infant egg allergy risk
2 Aug, 2023 | 13:47h | UTCSee also: Visual Abstract
RCT | Early vs. delayed intrauterine balloon tamponade: no difference in severe postpartum hemorrhage
2 Aug, 2023 | 13:42h | UTCEfficacy 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 | UTCCommentary: 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 | UTCCervical 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 | UTCZuranolone 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 | UTCUrinary 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
Cohort Study | The role of antiphospholipid syndrome and specific antibodies in predicting SLE pregnancy complications
25 Jul, 2023 | 13:44h | UTCPregnancy 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