Search Results (447)

Objectives: To evaluate the clinical characteristics, complication rates, and predictors of adverse outcomes related to peripherally inserted central catheters (PICC) in newborns over a seven-year period in a tertiary neonatal intensive care unit (NICU). Materials and Methods: This retrospective observational study included all neonates who underwent their first PICC placement between January 2017 and January 2024 in a single tertiary NICU. Demographic, clinical, and procedural data were collected, including birth weight, gestational age, catheter type, insertion site, dwell time, and reason for removal. Primary outcomes were PICC-related complications and catheter dwell time. Statistical analyses included chi-square or Fisher’s exact tests, Student’s t-test or ANOVA, and multivariable logistic regression to identify independent predictors of complications. Results: A total of 610 PICCs were evaluated. The mean gestational age was 31.0 ± 4.7 weeks, and the mean birth weight was 1579 ± 870 g. The majority of catheters (96.1%) terminated at the central location, with a mean dwell time of 12.9 ± 9.0 days. The most common removal reason was completion of therapy (60.3%), followed by mechanical complications (36.7%) and suspected infection (14.6%). Overall complication rate was 34.9%. In multivariable analysis, birth weight > 1000 g was associated with a lower risk of complications compared to <1000 g (1000–1500 g: OR 0.35, 95% CI 0.22–0.56; 1500–2000 g: OR 0.29, 0.15–0.54; >2000 g: OR 0.44, 0.21–0.92). Midline (OR 4.16, 1.76–9.83) and peripheral (OR 3.51, 1.82–6.76) terminations carried higher risk compared to central terminations. Use of antimicrobial-impregnated catheters reduced complication risk (OR 0.44, 0.26–0.74), while temporal vein insertion increased it (OR 4.14, 1.23–13.86). Conclusions: Low birth weight (<1000 g) and non-central catheter tip location are significant predictors of PICC-related complications in neonates, while antimicrobial-impregnated catheters have a protective effect. Targeted preventive strategies, strict adherence to insertion and maintenance bundles, and careful patient selection are recommended to improve outcomes in NICU patients. Full article

Background/Objectives: Preterm infants in the neonatal intensive care unit (NICU) are subjected to clinically essential painful procedures including peripherally inserted central catheter (PICC) placement. Pharmacological interventions are inconsistently used for procedural analgesia due to concerns of adverse events. Intranasal (IN) fentanyl is a promising pharmacological alternative that delivers rapid targeted analgesia. The objectives of this blinded randomized controlled trial (RCT) were to assess the feasibility of conducting a definitive RCT of IN fentanyl for PICC placement in preterm infants and evaluate the acceptability and adoption of IN fentanyl for procedural pain management in the NICU. Methods: Infants admitted to the NICU (Mount Sinai Hospital, Toronto) with a gestational age (GA) at birth < 32 weeks undergoing their first PICC placement were randomized to IN fentanyl or placebo as an add-on to standard of care. The primary feasibility outcomes were recruitment and completeness of data collection for pain assessment. The pre-specified targets were recruitment of 24 participants and at least 80% of video-recordings being suitable for pain assessment. Secondary outcomes were adverse events, and IN fentanyl acceptability and adoption by healthcare providers. (ClinicalTrials.gov ID NCT06590870). Results: Between August 2024 and January 2025, 16 parents/guardians were approached resulting in eight enrollments for a consent rate of 50% (95% CI 28, 72). The target recruitment of 24 participants was not achieved. Out of six infants that received study interventions, all video-recordings were suitable for pain assessment by outcome assessors with a success rate of 100% (95% CI 61, 100). There were no adverse events. Fifteen healthcare providers completed the survey and reported acceptability of IN fentanyl but barriers with its adoption in clinical practice. Conclusions: Major modifications to the recruitment strategy would be required to progress to a definitive RCT. Strategies facilitating IN fentanyl adoption for procedural analgesia in the NICU are needed. Full article

Background: Intrahepatic cholestasis of pregnancy (ICP) is the most common reversible liver disorder linked to pregnancy, characterised by pruritus and elevated serum bile acids (BAs). Condition severity correlates with increased maternal and neonatal complications, and recent evidence highlights a significantly elevated risk of adverse perinatal outcomes, including stillbirth, when BA > 100 µmol/L. Methods: This retrospective study, conducted at a tertiary perinatology centre between 2019 and 2023, was performed in two phases. In the first phase, baseline group characteristics and pregnancy outcomes were compared between ICP and non-ICP (control) groups. In the second phase, outcomes were analysed across three ICP severity subgroups: mild (BA < 40 µmol/L), moderate (BA 40–99 µmol/L), and severe (BA ≥ 100 µmol/L). Results: A total of 210 patients diagnosed with ICP and 24,177 controls were included in the analysis. After multivariable regression, the results indicated that patients with severe ICP (BA ≥ 100 µmol/L) experienced significantly worse perinatal outcomes compared to those with mild or moderate disease: spontaneous preterm birth occurred in 26.7% of cases (p = 0.002), iatrogenic preterm birth in 36.7% (p < 0.001), meconium-stained amniotic fluid in 43.3% (p = 0.001), and neonatal intensive care unit (NICU) admission in 23.3% (p = 0.006). This subgroup also had the lowest mean birth weight (2830 g, p < 0.001). Notably, no stillbirths were recorded in any of the subgroups. Compared to controls, no major differences in maternal characteristics were noted, except in pregnancies conceived via in vitro fertilisation (IVF, p = 0.012) and those complicated by gestational diabetes (p = 0.040), both showing elevated risk for ICP development. Conclusions: This study confirms an association between ICP and increased perinatal complications, with severity of disease correlating with poorer outcomes. The findings highlight the need for standardised BA testing and improved strategies for perinatal management. Full article

Background/Objectives: Conventional Coagulation Tests (CCTs) fail to accurately reflect Preeclampsia’s (PE’s) coagulation status, disease progression, and hemostatic alterations. They do not differentiate between the normal hypercoagulability of healthy pregnancies and the pathological hypercoagulability associated with PE. Rotational Thromboelastometry (ROTEM) analyzes clot dynamics from initiation through amplification and propagation to termination and fibrinolysis. However, their application in PE, particularly in neonates born to women with PE, is limited. We aimed to identify the hemostatic alterations in pregnant women with PE using ROTEMs that remain undetected by CCTs and to assess PE’s impact on neonatal hemostasis at birth. Methods: This was a single-center observational study (March 2022–March 2024) including 31 women with PE (34 newborns) and 45 pregnancies without PE (47 newborns). Maternal blood was collected intrapartum before placental delivery. Neonatal arterial samples were obtained within the first hour of life before vitamin K administration. ROTEM (Intrinsic (INTEM), Extrinsic (EXTEM), Fibrinogen (FIBTEM), Aprotinin (APTEM)), and CCTs were performed. Subgroup analyses considered PE severity and onset. ROC analyses examined discrimination for persistent maternal thrombocytopenia within 7 days of delivery and association with maternal platelet transfusion. Results: In preeclamptic women, the INTEM and FIBTEM assays were more affected, with higher Actual Clot Firmness (ACF) (p = 0.03, p = 0.04, respectively) and a higher Clot Formation Rate (CFR) (p = 0.03, p = 0.02, respectively). Hyperfibrinolysis was present (CT-APTEM < CT-EXTEM, MCF-APTEM > MCF-EXTEM). Clot Formation Time CFT-EXTEM was an indicator of maternal platelet transfusion (AUC = 0.81). Across EXTEM, INTEM, and APTEM, A10 (Amplitude at 10 min) and CFT showed good discrimination capability for maternal persistent thrombocytopenia within 7 days of delivery (AUCs 0.82–0.95). Neonates of women with PE presented lower ACF across all assays (INTEM p = 0.003; EXTEM p = 0.001; FIBTEM p = 0.01; APTEM p < 0.001), consistent across severity/onset subgroups. Conclusions: In this cohort, ROTEM identified maternal hypercoagulability with hyperfibrinolysis and neonatal hypocoagulability during the first hour of life. Several alterations were not reflected in CCTs. Further prospective studies should evaluate the role and clinical utility of combining ROTEM with CCTs for hemostatic monitoring in women with PE and their neonates. Full article

With persistent racial inequities, cultural adaptations of health programs can promote equitable maternal mental health. Despite the intersecting identities of Black mothers with preterm birth combined with racial discrimination, previous mental health programs in the neonatal intensive care unit (NICU) are void of the sociocultural context that perpetuates racially motivated care. This study uses a two-round Delphi process to gather knowledge on the cultural appropriateness and content validity of the adapted Mothers and Babies Online Course, a United States Prevention Service Task Force-recommended intervention for managing mental health symptoms in pregnant and new mothers for Black mothers with preterm birth. The Black feminist theory and cultural adaptation strategies were used to conceptualize the adaptation process. Opinions were solicited from Black mothers and professionals based on predetermined criteria. Eleven participants, comprising eight mothers and three professionals, participated in Round One. Of these, only one professional did not participate in Round Two, totaling 10 participants who participated in Round Two. The participants rated the adapted program—eMB 4 Blackmamas, positively, and four themes emerged, substantiating the importance of culturally responsive mental health. The themes also offered additional feedback related to improving the program delivery. Including diverse stakeholders in mental health research offers unique and balanced insights into designing culturally appropriate programs to promote and protect Black maternal mental health in the NICU. Full article

Aim: We aimed to investigate the incidence, treatment patterns, and associated risk factors of type 1 retinopathy of prematurity (ROP) in the only tertiary-level Neonatal Intensive Care Unit (NICU) in Cyprus. Methods: This retrospective study included all infants screened for ROP between January and December 2023. Data were collected from standardized NICU discharge summaries and included gestational age (GA), birth weight (BW), multiple birth, systemic infection, blood transfusion, oxygen therapy, surgical interventions, and ROP outcomes. Infants were categorized into non-ROP, non-type 1 ROP, and type 1 ROP groups. Statistical analysis was performed to identify differences in risk factor distribution. Results: Among 183 infants, 33 (18.0%) developed ROP, with 11 (6.0%) requiring treatment for type 1 ROP. All infants with type 1 ROP were born at ≤28 weeks GA and weighed <1501 g. Type 1 ROP was significantly associated with lower GA, lower BW, systemic infection, surgery, and prolonged oxygen support (p < 0.05). Six infants were treated with laser and three with intravitreal bevacizumab. No recurrence was observed in the anti-VEGF group during 18 months of follow-up. Two infants with aggressive ROP died before treatment. Conclusions: Type 1 ROP in Cyprus occurred exclusively in extremely preterm infants, associated with the cumulative effect of multiple risk factors. Laser remained the primary treatment, while anti-VEGF was used selectively with favorable outcomes. This study emphasizes the importance of tailoring ROP screening and treatment strategies based on individual neonatal risk profiles, supporting a personalized approach to neonatal ophthalmic care. Full article

Background/Objectives: Early pain exposure in newborns is linked to negative short- and long-term outcomes. Preterm infants often require endotracheal intubation for mechanical ventilation or brief laryngoscopy for surfactant administration via Less Invasive Surfactant Administration (LISA) or Intubation–Surfactant–Extubation (INSURE). While premedication before intubation is well-studied, data regarding premedication for LISA/INSURE are limited. We aimed to explore premedication practices for intubation and LISA/INSURE procedures across Neonatal Intensive Care Units (NICUs) in Israel. Methods: An anonymous online questionnaire comprising 27 questions about premedication practices was distributed to neonatal caregivers in Israel. The questions addressed the use of premedication before intubation or LISA/INSURE, the existence of written protocols, pharmacological agents employed, and caregiver satisfaction with the medications used. Results: Questionnaires were collected between January and July 2023, yielding 69 responses from 20 NICUs. Almost all respondents (95.7%) routinely use premedication before intubation, but only 65.7% use it for LISA/INSURE. For non-emergency intubations, extremely low-birth-weight (ELBW) infants received premedication less often than the general neonatal population (75.4% vs. 95.7%, respectively). Most caregivers (91.2%) did not report increased procedure failure associated with premedication during LISA/INSURE. The vast majority of Israeli caregivers do not include muscle relaxants in their premedication regimen for intubation. Dual therapy regimens yielded higher satisfaction rates than monotherapy. Higher complication rates, particularly respiratory depression, were observed with Fentanyl, especially when used as monotherapy. Conclusions: Significant variations exist in premedication practices among caregivers across Israeli NICUs. Premedication is commonly administered for intubation but is considerably less frequent for LISA/INSURE, despite these procedures also being painful. ELBW infants received less premedication. Notably, muscle relaxants are infrequently used for premedication by Israeli NICU caregivers. Full article

Postnatal cytomegalovirus (pCMV) infection is typically asymptomatic in term infants but poses significant risks to very preterm and very low birth weight (VLBW) infants. The primary mode of transmission of pCMV is breast milk from seropositive mothers. Here, we present the case of a 29-week preterm female who contracted pCMV and began to manifest symptoms at day of life (DOL) 50. She developed respiratory compromise, massive ascites, and was extremely ill. The patient was managed with ganciclovir (GCV), intravenous immunoglobulins (IVIG), and percutaneous drainage of the ascites. She gradually improved and was discharged after a 5-month neonatal intensive care unit (NICU) stay. After presenting the case, we review the clinical manifestations of pCMV, and particularly its less well-recognized gastrointestinal manifestations, including ascites. We then outline guidelines for treatment and prevention. Clinicians should consider pCMV in VLBW and extremely premature infants presenting with thrombocytopenia, colitis, or ascites, especially in the second and third months of life. Full article

Background/Objectives: Bronchopulmonary dysplasia (BPD) is a chronic lung disease affecting preterm infants, often resulting in prolonged neonatal intensive care unit (NICU) stays and significant parental stress. The experiences of parents navigating their preterm infant’s early NICU journey are important to support clinical trials to improve infant outcomes. Aim: The aim of this study was to explore parental perceptions of their infant’s health progression during the first 10 days of life through personal diary entries and their correlation with the echo scans assessments, as part of the Exploring Right vEntricular function applicability in a Prediction mOdel to identify pReterm infanTs with early BronchoPulmonary Dysplasia (REPORT-BPD) feasibility study. Methods: An embedded qualitative design was employed, utilising thematic analysis of 17 parent diaries. Parents of preterm infants (<32 weeks of gestation) admitted to a NICU documented their daily experiences. Thematic analysis was applied to ensure a rigorous, inductive examination of emerging themes. Findings: Four main themes were identified: (1) developing parent–infant relationships, highlighting the emotional impact of separation and the significance of bonding; (2) health and well-being of premature infants and family, reflecting parental vigilance, cautious optimism, and emotional distress; (3) parents navigating support and the NICU environment, describing challenges related to medical procedures, communication with staff, and adapting to a highly technical setting; and (4) emotions and protective gestures, illustrating parental resilience, coping mechanisms, and the innate drive to protect their child. Conclusions: Parental experiences in the NICU were shaped by emotional turmoil, uncertainty, and the need for support in navigating their infant’s care. Diaries provided an effective means for parents to express their experiences; they could serve as a communication tool in clinical trials to provide a deeper understanding of the development of the recruited preterm infants. Full article

Parvovirus B19 (B19V) re-emerged across Europe in 2024, raising concerns about vertical transmission and neonatal morbidity. We undertook a prospective, single-centre cohort study to characterise the early clinical course of congenitally infected neonates born between April and December 2024. Seventy-one pregnancies with serologically or PCR-confirmed maternal infection were enrolled; seven neonates met laboratory criteria for congenital B19V infection and were followed with serial clinical, biochemical and imaging assessments through the first year of life. Troponin I and CK-MB were measured on days 1, 3, 7 and 15; electrocardiogram (ECG) and echocardiography were repeated in parallel, and cranial ultrasound (US), ophthalmologic and audiologic screening were scheduled prospectively. Mean troponin rose from 50.7 ng L⁻¹ on day 1 to a peak of 120.7 ng L⁻¹ on day 7 (p < 0.01), normalising by one month, while echocardiograms remained structurally normal, and only one transient arrhythmia was recorded. CK-MB exceeded the reference range in 29% of infants but showed no clinical sequelae. Multiple periventricular hyperechogenicities were identified in 8/70 neonates (11%), and moderate anaemia (Hb ≤ 9.8 g/dL) occurred in 2 cases. Serum PCR detected high-level viraemia (>10⁸ genome equivalents mL⁻¹) in 40% of those tested; saliva and urine were consistently negative. No instances of myocarditis or hydrops were observed. Our findings indicate that congenital B19V infection during the current outbreak is marked by transient biochemical myocardial stress and subtle neurosonographic changes rather than overt cardiac disease, supporting an outpatient-focused follow-up strategy incorporating serial biomarkers and targeted neuroimaging. Full article

Background: Nutrition is of paramount importance during early development, since suboptimal growth in this period of life is linked to adverse long- and mid-term outcomes. This is particularly relevant for preterm infants, who fail to thrive during the first weeks of life and develop extrauterine growth restriction (EUGR). This group of premature babies represents an interesting population to investigate using a metabolomic approach to optimize nutritional intake. Aims: To analyse and compare the urinary metabolomic pattern at birth of preterm infants with and without growth restriction at 36 weeks of postmenstrual age or at discharge, searching for putative markers of growth failure. Methods: We enrolled preterm infants between 23 and 32 weeks of gestational age (GA) and/or with a birth weight <1500 g, admitted to the Neonatal Intensive Care Unit (NICU) at the Department of Women’s and Children’s Health of Padova University Hospital. We collected urinary samples within 48 h of life and performed untargeted metabolomic analysis using mass spectrometry. Results: Sixteen EUGR infants were matched with sixteen non-EUGR controls. The EUGR group showed lower levels of L-cystathionine, kynurenic acid, L-carnosine, N-acetylglutamine, xanthurenic acid, aspartylglucosamine, DL5-hydroxylysine-hydrocloride, homocitrulline, and L-aminoadipic acid, suggesting a lower anti-inflammatory and antioxidant status with respect to the non-EUGR group. Conclusions: Metabolomic analysis suggests a basal predisposition to growth restriction, the identification of which could be useful for tailoring nutritional approaches. Full article

Background: Preterm infants and their families face a challenging experience during their stay in the neonatal intensive care unit (NICU). Family-centered care emphasizes the importance of welcoming parents, involving them in their baby’s daily care, and supporting the development of parenting skills. NICU staff should support parents in understanding their baby’s needs and in strengthening the parent–infant bond. Although many tools outline what parents should learn, there is a limited structured framework to monitor their involvement in the infant’s care. Tracking parental participation in daily caregiving activities could support professionals in effectively guiding families, ensuring a smoother transition to discharge. Aims: The aim of this study was to evaluate the adherence to and effectiveness of a structured tool for parental involvement in the NICU. This tool serves several key purposes: to track the progression and timing of parents’ autonomy in caring for their baby, to support parents in building caregiving competencies before discharge, and to standardize the approach of NICU professionals in promoting both infant care and family engagement. Methods: A structured template form for documenting parental involvement (“together TO-CARE template”, TTCT) was integrated into the computerized chart adopted in the NICU of Modena. Nurses were asked to complete the TTCT at each shift. The template included the following assessment items: parental presence; type of contact with the baby (touch; voice; skin-to-skin); parental involvement in care activities (diaper changing; gavage feeding; bottle feeding; breast feeding); and level of autonomy in care (observer; supported by nurse; autonomous). We evaluated TTCT uploaded data for very low birth weight (VLBW) preterm infants admitted in the Modena NICU between 1 January 2023 and 31 December 2024. Staff compliance in filling out the TTCT was assessed. The timing at which parents achieved autonomy in different care tasks was also measured. Results: The TTCT was completed with an average of one entry per day, during the NICU stay. Parents reached full autonomy in diaper changing at a mean of 21.1 ± 15.3 days and in bottle feeding at a mean of 48.0 ± 22.4 days after admission. The mean length of hospitalization was 53 ± 38 days. Conclusions: The adoption of the TTCT in the NICU is feasible and should become a central component of care for preterm infants. It promotes family-centered care by addressing the needs of both the baby and the family. Encouraging early and progressive parental involvement enhances parenting skills, builds confidence, and may help reduce post-discharge complications and readmissions. Furthermore, the use of a standardized template aims to foster consistency among NICU staff, reduce disparities in care delivery, and strengthen the support provided to families of preterm infants. Full article

Background/Objectives: Platelet transfusions are administered to preterm neonates with thrombocytopenia prophylactically to decrease their bleeding risk. The amplitude difference between the extrinsic rotational thromboelastometry (EXTEM) and the fibrinogen rotational thromboelastometry (FIBTEM) assays is considered an index of platelet contribution to clot strength, guiding transfusion management. The difference in maximum clot elasticity (MCE) (namely the platelet contribution to clot elasticity—MCEplatelet) is considered highly accurate. Limited data exist to specify the contribution of platelets and fibrinogen in clot formation during sepsis in neonates with thrombocytopenia. We investigated the potential of MCFplatelet (platelet contribution to clot firmness) and MCEplatelet in reflecting platelet count and function in septic preterm neonates. We simultaneously assessed the contribution of both platelets and fibrinogen to clot strength during sepsis. Methods: We compared 28 preterm neonates with sepsis born (gestational age 24⁺¹-34⁺³) with 30 healthy counterparts by using rotational thromboelastometry (ROTEM) and platelet flow cytometry. Results: MCEplatelet showed a higher association with platelet count in the sepsis group than MCFplatelet (R² = 47.66% vs. R² = 18.79%). MCEplatelet (AUC = 0.81) had better discrimination capability than MCFplatelet (AUC = 0.78) in platelet count <100 × 10³/L. MCEplatelet was poorly associated with platelet function. The contribution of platelets was significantly lower (MCEplatelet = 84.03 vs. 89.21; p < 0.001) compared with fibrinogen (36.9 vs. 25.92; p < 0.001) in the sepsis group. Conclusions: MCEplatelet has a better predictive value than MCFplatelet. In clinical practice, the elasticity difference between EXTEM and FIBTEM may replace the amplitude difference. The higher contribution of fibrinogen in clot strength during neonatal sepsis results in higher MCF, even in neonates with thrombocytopenia. Full article

Background/Objectives: Infants admitted to neonatal intensive care units (NICUs) face challenges in achieving successful oral feedings. During oral feedings, these infants commonly present with suck–swallow–breathe incoordination, with approximately 30% developing dysphagia, leading to feeding aversion, prolonged hospitalization, and increased parental stress. Cold liquid feeding has demonstrated benefits in improving feeding safety in adults with dysphagia; however, its application in neonates is relatively limited. This study aimed to examine global neonatal feeding practices, with a specific emphasis on cold milk feeding as an intervention for dysphagia. Methods: A cross-sectional global electronic survey was distributed via professional society listservs and closed online professional group forums targeting neonatal providers and feeding therapists from June 2023 to June 2024. The survey assessed institutional feeding protocols, oral feeding practices, and the use of cold milk for infants with dysphagia. Responses were analyzed descriptively. Results: A total of 210 complete responses were received from level IV (51%), level III (42%), and level II (5%) NICUs. While 30% of the respondents were aware of cold milk feeding as a dysphagia intervention, only 15% of the total respondents reported using it in practice. Among the 32 institutions implementing cold milk practices, only one had an established protocol. Additionally, 72% reported having a feeding protocol in place, often incorporating cue-based tools. Most respondents (87.5%) did not allow oral feeding during nasal continuous positive airway pressure (nCPAP), whereas 78% permitted it during high-flow nasal cannula (HFNC) support. Conclusions: Although the awareness of cold milk feeding in neonates is increasing, its implementation remains limited and lacks standardization. Significant variability exists in oral feeding practices, particularly regarding feeding during respiratory support. This underscores the need for further research and evidence-based guidelines to ensure safe and consistent care for preterm infants. Full article

Background/Objectives: As the incidence of diabetes mellitus (DM) is increasing rapidly worldwide, it is anticipated that an increasing number of women will enter pregnancy with pregestational diabetes mellitus (PGDM) in the future. Compelling evidence suggests that hyperglycemia in pregnancy is related to multiple adverse perinatal outcomes. This systematic review and meta-analysis aims to assess and quantify the association of PGDM with a range of adverse perinatal outcomes, providing a comprehensive understanding of its impact on pregnancy. Methods: The data sources of this systematic review and meta-analysis were Medline/PubMed, Scopus and Cochrane Library (January 1999 to August 2023), complemented by hand-searching for additional references. Observational studies reporting perinatal outcomes of pregnancies with PGDM diagnosed before pregnancy versus control pregnancies were eligible for inclusion. A systematic review and meta-analysis were conducted as per the PRISMA guidelines. Pooled estimate odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to determine the risk of adverse pregnancy outcomes between PGDM and control pregnancies. Results: The systematic search of the literature yielded 81 observational studies meeting inclusion criteria and in total, 137,237,640 pregnancies were included in the analysis. A total of 19 adverse perinatal outcomes were assessed, revealing a significant association with PGDM. In pregnancies with PGDM there was an increased risk of adverse perinatal outcomes, including gestational hypertension (OR 3.16, 95% CI 2.65–3.77), preeclampsia (OR 4.46, 95% CI 3.94–5.05), preterm delivery (OR 3.46, 95% CI 3.06–3.91), cesarean delivery (OR 3.12, 95% CI 2.81–3.47), induction of labor (OR 2.92, 95% CI 2.35–3.63), macrosomia (OR 2.23, 95% CI 1.76–2.83), LGA neonates (OR 3.95, 95% CI 3.47–4.49), low 5-min Apgar score (OR 2.49, 95% CI 2.07–2.99), shoulder dystocia (OR 3.05, 95% CI 2.07–4.50), birth trauma (OR 1.40, 95% CI 1.22–1.62), polyhydramnios (OR 5.06, 95% CI 4.33–5.91), oligohydramnios (OR 1.61, 95% CI 1.19–2.17), neonatal hyperbilirubinemia (OR 3.45, 95% CI 2.51–4.74), neonatal hypoglycemia (OR 19.19, 95% CI 2.78–132.61), neonatal intensive care unit (NICU) admission (OR 4.54, 95% CI 3.87–5.34), congenital malformations (OR 2.44, 95% CI 1.96–3.04), stillbirth (OR 2.87, 95% CI 2.27–3.63) and perinatal mortality (OR 2.94, 95% CI 2.18–3.98). Subgroup analyses indicated a higher risk of neonatal hypoglycemia, stillbirth and perinatal mortality in T1DM pregnancies compared with T2DM pregnancies. Conclusions: This study provides a robust synthesis of evidence underlying the strong association between PGDM and several adverse perinatal outcomes. Early detection, optimal glycemic control during the periconceptional and pregnancy periods, and proper antenatal care are critical to mitigate these risks. Full article