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1.
Obstet Gynecol ; 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38843529

ABSTRACT

Previous models for prediction of vaginal birth after cesarean (VBAC) relied on race and ethnicity, raising concern for bias. In response, the Maternal-Fetal Medicine Units Network (MFMU) created a new prediction model without race and ethnicity for individuals with one prior cesarean delivery. We performed a secondary analysis of the MFMU Cesarean Registry database to evaluate whether the MFMU VBAC prediction model without race and ethnicity could accurately predict VBAC for individuals with two prior cesarean deliveries. Overall, 353 individuals were included and 252 (71%) had VBAC. An area under the curve for the receiver operating curve of 0.74 (95% CI, 0.69-0.80) was reported for the predicted probabilities for VBAC, indicating that the model can be used for prediction of VBAC in this population.

2.
EClinicalMedicine ; 73: 102654, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38828129

ABSTRACT

Background: Little is known about post-acute sequelae of SARS-CoV-2 infection (PASC) after acquiring SARS-CoV-2 infection during pregnancy. We aimed to evaluate the association between acquiring SARS-CoV-2 during pregnancy compared with acquiring SARS-CoV-2 outside of pregnancy and the development of PASC. Methods: This retrospective cohort study from the Researching COVID to Enhance Recovery (RECOVER) Initiative Patient-Centred Clinical Research Network (PCORnet) used electronic health record (EHR) data from 19 U.S. health systems. Females aged 18-49 years with lab-confirmed SARS-CoV-2 infection from March 2020 through June 2022 were included. Validated algorithms were used to identify pregnancies with a delivery at >20 weeks' gestation. The primary outcome was PASC, as previously defined by computable phenotype in the adult non-pregnant PCORnet EHR dataset, identified 30-180 days post-SARS-CoV-2 infection. Secondary outcomes were the 24 component diagnoses contributing to the PASC phenotype definition. Univariable comparisons were made for baseline characteristics between individuals with SARS-CoV-2 infection acquired during pregnancy compared with outside of pregnancy. Using inverse probability of treatment weighting to adjust for baseline differences, the association between SARS-CoV-2 infection acquired during pregnancy and the selected outcomes was modelled. The incident risk is reported as the adjusted hazard ratio (aHR) with 95% confidence intervals. Findings: In total, 83,915 females with SARS-CoV-2 infection acquired outside of pregnancy and 5397 females with SARS-CoV-2 infection acquired during pregnancy were included in analysis. Non-pregnant females with SARS-CoV-2 infection were more likely to be older and have comorbid health conditions. SARS-CoV-2 infection acquired in pregnancy as compared with acquired outside of pregnancy was associated with a lower incidence of PASC (25.5% vs 33.9%; aHR 0.85, 95% CI 0.80-0.91). SARS-CoV-2 infection acquired in pregnant females was associated with increased risk for some PASC component diagnoses including abnormal heartbeat (aHR 1.67, 95% CI 1.43-1.94), abdominal pain (aHR 1.34, 95% CI 1.16-1.55), and thromboembolism (aHR 1.88, 95% CI 1.17-3.04), but decreased risk for other diagnoses including malaise (aHR 0.35, 95% CI 0.27-0.47), pharyngitis (aHR 0.36, 95% CI 0.26-0.48) and cognitive problems (aHR 0.39, 95% CI 0.27-0.56). Interpretation: SARS-CoV-2 infection acquired during pregnancy was associated with lower risk of development of PASC at 30-180 days after incident SARS-CoV-2 infection in this nationally representative sample. These findings may be used to counsel pregnant and pregnant capable individuals, and direct future prospective study. Funding: National Institutes of Health (NIH) Other Transaction Agreement (OTA) OT2HL16184.

3.
Am J Obstet Gynecol ; 231(1): 128.e1-128.e11, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38346912

ABSTRACT

BACKGROUND: Venous thromboembolism accounts for approximately 9% of pregnancy-related deaths in the United States. National guidelines recommend postpartum risk stratification and pharmacologic prophylaxis in at-risk individuals. Knowledge on modern rates of postpartum pharmacologic thromboprophylaxis and its associated risks is limited. OBJECTIVE: This study aimed to describe the rate of, and factors associated with, initiation of postpartum pharmacologic prophylaxis for venous thromboembolism, and to assess associated adverse outcomes. STUDY DESIGN: This was a secondary analysis of a multicenter cohort of individuals delivering on randomly selected days at 17 US hospitals (2019-2020). Medical records were reviewed by trained and certified personnel. Those with an antepartum diagnosis of venous thromboembolism, receiving antepartum anticoagulation, or known SARS-CoV-2 infection were excluded. The primary outcome was use of postpartum pharmacologic thromboprophylaxis. Secondary outcomes included bleeding complications, surgical site infection, hospital readmission, and venous thromboembolism through 6 weeks postpartum. The rate of thromboprophylaxis administration was assessed by mode of delivery, institution, and continuance to the outpatient setting. Multivariable regression models were developed using k-fold cross-validation with stepwise backward elimination to evaluate factors associated with thromboprophylaxis administration. Univariable and multivariable logistic models with propensity score covariate adjustment were performed to assess the association between thromboprophylaxis administration and adverse outcomes. RESULTS: Of 21,114 individuals in the analytical cohort, 11.9% (95% confidence interval, 11.4%-12.3%) received postpartum pharmacologic thromboprophylaxis; the frequency of receipt was 29.8% (95% confidence interval, 28.7%-30.9%) following cesarean and 3.5% (95% confidence interval, 3.2%-3.8%) following vaginal delivery. Institutional rates of prophylaxis varied from 0.21% to 34.8%. Most individuals (83.3%) received thromboprophylaxis only as inpatients. In adjusted analysis, cesarean delivery (adjusted odds ratio, 19.17; 95% confidence interval, 16.70-22.00), hysterectomy (adjusted odds ratio, 15.70; 95% confidence interval, 4.35-56.65), and obesity (adjusted odds ratio, 3.45; 95% confidence interval, 3.02-3.95) were the strongest factors associated with thromboprophylaxis administration. Thromboprophylaxis administration was not associated with surgical site infection (0.9% vs 0.6%; odds ratio, 1.48; 95% confidence interval, 0.80-2.74), bleeding complications (0.2% vs 0.1%; odds ratio, 2.60; 95% confidence interval, 0.99-6.80), or postpartum readmission (0.9% vs 0.3%; adjusted odds ratio, 1.38; 95% confidence interval, 0.68-2.81). The overall rate of venous thromboembolism was 0.06% (95% confidence interval, 0.03%-0.10%) and was higher in those receiving prophylaxis (0.2%) compared with those not receiving prophylaxis (0.04%). CONCLUSION: Approximately 1 in 10 patients received postpartum pharmacologic thromboprophylaxis in this US cohort. Rates of prophylaxis varied widely by institution. Cesarean delivery, hysterectomy, and obesity were predominant factors associated with postpartum thromboprophylaxis administration.


Subject(s)
Venous Thromboembolism , Humans , Female , Venous Thromboembolism/prevention & control , Venous Thromboembolism/epidemiology , Adult , Pregnancy , United States/epidemiology , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Postpartum Period , Patient Readmission/statistics & numerical data , Cohort Studies , Surgical Wound Infection/prevention & control , Surgical Wound Infection/epidemiology , Cesarean Section , Postpartum Hemorrhage/prevention & control , Postpartum Hemorrhage/epidemiology , Puerperal Disorders/prevention & control , Puerperal Disorders/epidemiology , Retrospective Studies
4.
Hum Reprod ; 39(2): 425-435, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-37968231

ABSTRACT

STUDY QUESTION: Are there significant associations existing between parental age differences and adverse perinatal outcomes? SUMMARY ANSWER: Large differences in parental age are associated with adverse perinatal outcomes, particularly with older mothers paired with younger fathers. WHAT IS KNOWN ALREADY: The association between advanced maternal age and perinatal outcomes is well-documented with women over 35 years showing an increased risk of several adverse outcomes. Other studies have identified potential associations between advanced paternal age and adverse perinatal outcomes. STUDY DESIGN, SIZE, DURATION: A historical (retrospective) cohort analysis was performed utilizing a multivariable logistic regression model to evaluate the association between varying differences in parental age and adverse perinatal outcomes while controlling for demographic and health-related covariates. Data were compiled from the National Vital Statistics System for 20 613 704 births between 2012 and 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: Parental age differences, categorized into eleven 4-year intervals, were stratified by seven maternal age categories and evaluated for their associations with adverse perinatal outcomes. Main outcome measures included low birth weight, very low birth weight, preterm birth, very preterm birth, small size for gestational age, low 5-min appearance, pulse, grimace, activity, and respiration score, congenital defects, and chromosomal anomalies. MAIN RESULTS AND THE ROLE OF CHANCE: Increased parental age differences, in either direction, were associated with significant risks for all adverse outcomes, aside from congenital defects, even when controlling for maternal age. Restricting maternal age to the reference range of 25-29 years, infants born to fathers aged 9-12 years younger (n = 3773) had 27% (odds ratio (OR) 1.27, 95% CI, 1.17-1.37) higher odds of having any adverse perinatal outcome. Infants born to fathers aged >16 years older (n = 98 555) had 14% (OR 1.14, 95% CI, 1.12-1.16) higher odds of having any adverse perinatal outcome. LIMITATIONS, REASONS FOR CAUTION: Data extracted from US birth certificates may be compromised by errors in reporting or documentation. Information regarding the mother's socioeconomic status was estimated using proxy variables and may be susceptible to uncontrolled factors. Use of a pre-compiled dataset may potentially exclude additional maternal comorbidities that could impact perinatal outcomes. WIDER IMPLICATIONS OF FINDINGS: Older mothers paired with younger fathers demonstrated the highest risk, even when maternal age was below the threshold of 35 years. For the clinical setting, parental age differences should be considered alongside maternal and paternal age when assessing risks of adverse perinatal outcomes for potential parents. This is particularly relevant for older women with younger male partners as this may exacerbate the impact of advanced maternal age. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the NIH Research Fellowship T35 Training Grant. There are no competing interests. TRIAL REGISTRATION NUMBER: N/A.


Subject(s)
Premature Birth , Pregnancy , Humans , Male , Infant, Newborn , Female , Aged , Premature Birth/etiology , Retrospective Studies , Infant, Low Birth Weight , Parturition , Mothers
5.
Urology ; 183: 228-235, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37838002

ABSTRACT

OBJECTIVE: To investigate the association of low-grade radiation injury (LGRI) and high-grade radiation injury (HGRI) following prostate cancer treatment with mental health diagnoses and therapy. METHODS: A retrospective study of men diagnosed with prostate cancer who were treated with radiotherapy. Men were followed to assess for LGRI or HGRI using IBM MarketScan. Cohorts included: no injury (no-RI), LGRI, HGRI, and controls. Mental health diagnoses and related treatment (medication/therapy) were identified using ICD-10 codes, CPT codes, and national drug codes. A multivariable Cox proportional hazards model from time of radiation to first instance of mental health diagnosis was modeled against injury group, age, and comorbidities. RESULTS: Between 2011 and 2020 we identified 55,425 men who received radiotherapy for prostate cancer. 22,879 (41.3%) experienced a LGRI while 4128 (7.4%) experienced a HGRI. Prior to radiation therapy, mental health diagnoses were equally distributed across cohorts (P > .05). Every marker of mental health showed a step-wise increase in incidence from no-RI to LGRI to HGRI except for alcohol abuse. Use of mental health medications and therapy visits were slightly more likely in the LGRI and HGRI groups prior to radiation, however, this difference was greatly increased postradiation therapy. LGRI (HR 1.38; P < .001) and HGRI (HR 2.1; P < .001) were independently associated with an increased likelihood of mental health diagnoses. CONCLUSION: LGRI and HGRI following prostate cancer radiotherapy are associated with increased risk of mental health diagnosis, medication use, and therapy need compared to men who do not develop injuries. The most common mental health diagnoses were depression and anxiety.


Subject(s)
Prostatic Neoplasms , Radiation Injuries , Male , Humans , Retrospective Studies , Mental Health , Prostatic Neoplasms/therapy , Prostatic Neoplasms/radiotherapy , Urogenital System
6.
Am J Perinatol ; 41(S 01): e3391-e3400, 2024 May.
Article in English | MEDLINE | ID: mdl-38134939

ABSTRACT

OBJECTIVE: Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery. STUDY DESIGN: This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative [CMQCC]) and two regression models (Ahmadzia et al and Albright et al). The primary outcome was intrapartum or postpartum red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared. RESULTS: Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low risk, 5,259 (48.8%) as medium risk, and 3,556 (33.0%) as high risk with corresponding transfusion rates of 2.1% (95% confidence interval [CI]: 1.5-2.9%), 2.2% (95% CI: 1.8-2.6%), and 7.5% (95% CI: 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI: 0.76-0.81) and 0.79 (95% CI: 0.77-0.82), respectively (p = 0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion. CONCLUSION: Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S. COHORT: Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed. KEY POINTS: · A total of 3.9% of individuals received a blood transfusion during cesarean delivery admission.. · Three models used in clinical practice are externally valid for blood transfusion prediction.. · Institutional model selection should be based on ease of application until further research identifies the optimal approach..


Subject(s)
Blood Transfusion , Cesarean Section , Adult , Female , Humans , Pregnancy , Algorithms , Antifibrinolytic Agents/therapeutic use , Area Under Curve , Blood Transfusion/statistics & numerical data , Erythrocyte Transfusion , Postpartum Hemorrhage/therapy , Risk Assessment/methods , ROC Curve , Tranexamic Acid/therapeutic use , United States
7.
Obstet Gynecol ; 143(1): 139-142, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-38096554

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is associated with increased risk for macro- and micro-thrombi. Consensus guidelines recommend use of thromboprophylaxis in nonobstetric patients with SARS-CoV-2 infection admitted to the hospital. National-level studies evaluating venous thromboembolism (VTE) among pregnant and postpartum individuals with and without SARS-CoV-2 infection have not been completed. We performed a retrospective cohort study of individuals aged 18 years or older delivering at more than 20 weeks of gestation with data in the MarketScan Commercial Insurance Database from 2016 through 2020. Of 811,008 deliveries, SARS-CoV-2 infection during pregnancy or through 6 weeks postpartum was associated with increased risk for VTE compared with no infection (1.0% vs 0.5%, adjusted hazard ratio 2.62, 95% CI 1.60-4.29). Findings support further consideration of thromboprophylaxis in the obstetric population with SARS-CoV-2 infection.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Venous Thromboembolism , Pregnancy , Female , Humans , COVID-19/epidemiology , Venous Thromboembolism/epidemiology , Venous Thromboembolism/prevention & control , SARS-CoV-2 , Retrospective Studies , Anticoagulants/therapeutic use , Postpartum Period , Pregnancy Complications, Infectious/epidemiology
8.
Am J Perinatol ; 2023 Dec 07.
Article in English | MEDLINE | ID: mdl-37967868

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with coagulation abnormalities and increased risk for venous and arterial thrombi. This study aimed to evaluate D-dimer levels and lupus anticoagulant (LAC) positivity in pregnant individuals with and without Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. STUDY DESIGN: This was a prospective cohort study of pregnant individuals delivering at a single academic institution from April 2020 to March 2022. Individuals with a positive SARS-CoV-2 result during pregnancy were compared with a convenience sample of those without a positive SARS-CoV-2 result. For individuals with SARS-CoV-2 infection, severity was assessed based on the National Institutes of Health classification system. The primary outcome was D-dimer level measured during delivery admission. The secondary outcomes were LAC positivity and thromboembolic events. Outcomes were compared between individuals with and without a positive SARS-CoV-2 result, and further by disease severity. RESULTS: Of 98 participants, 77 (78.6%) were SARS-CoV-2 positive during pregnancy. Among individuals with SARS-CoV-2 infection, severity was asymptomatic in 20 (26.0%), mild in 13 (16.9%), moderate in 4 (5.2%), severe in 38 (49.4%), and critical in 2 (2.6%). The D-dimer concentration at delivery did not significantly differ between those with a SARS-CoV-2 positive result compared with those without (mean 2.03 µg/mL [95% confidence interval {CI} 1.72-2.40] vs. 2.37 µg/mL [95% CI 1.65-3.40]; p = 0.43). Three individuals (4%) with SARS-CoV-2 infection and none (0%) without infection were LAC positive (p = 0.59). There were no clinically apparent thromboses in either group. D-dimer concentrations and LAC positive results did not differ by COVID-19 severity. CONCLUSION: Thrombotic markers did not differ in pregnant individuals by SARS-CoV-2 infection; however, high rates of LAC positivity were detected. KEY POINTS: · Thrombotic markers did not differ in pregnant individuals by SARS-CoV-2 infection.. · Higher than expected rates of LAC positivity were detected.. · There were no clinically apparent thromboses..

9.
JAMA Netw Open ; 6(4): e237396, 2023 04 03.
Article in English | MEDLINE | ID: mdl-37036706

ABSTRACT

Importance: Associations between prenatal SARS-CoV-2 exposure and neurodevelopmental outcomes have substantial public health relevance. A previous study found no association between prenatal SARS-CoV-2 infection and parent-reported infant neurodevelopmental outcomes, but standardized observational assessments are needed to confirm this finding. Objective: To assess whether mild or asymptomatic maternal SARS-CoV-2 infection vs no infection during pregnancy is associated with infant neurodevelopmental differences at ages 5 to 11 months. Design, Setting, and Participants: This cohort study included infants of mothers from a single-site prospective cross-sectional study (COVID-19 Mother Baby Outcomes [COMBO] Initiative) of mother-infant dyads and a multisite prospective cohort study (Epidemiology of Severe Acute Respiratory Syndrome Coronavirus 2 in Pregnancy and Infancy [ESPI]) of pregnant individuals. A subset of ESPI participants was subsequently enrolled in the ESPI COMBO substudy. Participants in the ongoing COMBO study were enrolled beginning on May 26, 2020; participants in the ESPI study were enrolled from May 7 to November 3, 2021; and participants in the ESPI COMBO substudy were enrolled from August 2020 to March 2021. For the current analysis, infant neurodevelopment was assessed between March 2021 and June 2022. A total of 407 infants born to 403 mothers were enrolled (204 from Columbia University Irving Medical Center in New York, New York; 167 from the University of Utah in Salt Lake City; and 36 from the University of Alabama in Birmingham). Mothers of unexposed infants were approached for participation based on similar infant gestational age at birth, date of birth, sex, and mode of delivery to exposed infants. Exposures: Maternal symptomatic or asymptomatic SARS-CoV-2 infection. Main Outcomes and Measures: Infant neurodevelopment was assessed using the Developmental Assessment of Young Children, second edition (DAYC-2), adapted for telehealth assessment. The primary outcome was age-adjusted standard scores on 5 DAYC-2 subdomains: cognitive, gross motor, fine motor, expressive language, and receptive language. Results: Among 403 mothers, the mean (SD) maternal age at delivery was 32.1 (5.4) years; most mothers were of White race (240 [59.6%]) and non-Hispanic ethnicity (253 [62.8%]). Among 407 infants, 367 (90.2%) were born full term and 212 (52.1%) were male. Overall, 258 infants (63.4%) had no documented prenatal exposure to SARS-CoV-2 infection, 112 (27.5%) had confirmed prenatal exposure, and 37 (9.1%) had exposure before pregnancy or at an indeterminate time. In adjusted models, maternal SARS-CoV-2 infection during pregnancy was not associated with differences in cognitive (ß = 0.31; 95% CI, -2.97 to 3.58), gross motor (ß = 0.82; 95% CI, -1.34 to 2.99), fine motor (ß = 0.36; 95% CI, -0.74 to 1.47), expressive language (ß = -1.00; 95% CI, -4.02 to 2.02), or receptive language (ß = 0.45; 95% CI, -2.15 to 3.04) DAYC-2 subdomain scores. Trimester of exposure and maternal symptom status were not associated with DAYC-2 subdomain scores. Conclusions and Relevance: In this study, results of a novel telehealth-adapted observational neurodevelopmental assessment extended a previous finding of no association between prenatal exposure to maternal SARS-CoV-2 infection and infant neurodevelopment. Given the widespread and continued high prevalence of COVID-19, these data offer information that may be helpful for pregnant individuals who experience asymptomatic or mild SARS-CoV-2 infections.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Prenatal Exposure Delayed Effects , Infant, Newborn , Child , Female , Pregnancy , Humans , Infant , Male , Child, Preschool , Adult , Cohort Studies , Prospective Studies , COVID-19/epidemiology , Prenatal Exposure Delayed Effects/epidemiology , Cross-Sectional Studies , Pregnancy Complications, Infectious/epidemiology , SARS-CoV-2
10.
Obstet Gynecol ; 141(1): 173-175, 2023 01 01.
Article in English | MEDLINE | ID: mdl-36701618

ABSTRACT

The vaginal birth after cesarean (VBAC) delivery rate was last reported as 13.8% in 2019. However, contemporary trends in attempted and successful trial of labor after cesarean (TOLAC) delivery among individuals with prior cesarean delivery have not been evaluated. We performed a repeated cross-sectional analysis of singleton, cephalic, term deliveries in individuals with a history of one or two cesarean deliveries in the National Vital Statistics System from 2010 to 2020. Temporal trends in attempted and successful TOLAC, as well as VBAC, were characterized using joinpoint regression. Overall, 4,277,800 deliveries were included. Attempted TOLAC increased from 15.3% in 2010 to 21.7% in 2020, with an annual percent increase (relative) of 4.25% (95% CI 2.9-5.6%). Successful TOLAC increased from 69.8% to 74.7%, with an annual percent change (relative) of 0.91% (95% CI 0.7-1.2%). The VBAC rate similarly increased such that, by 2020, it was 16.2%.


Subject(s)
Trial of Labor , Vaginal Birth after Cesarean , Pregnancy , Female , Humans , United States/epidemiology , Cross-Sectional Studies , Cesarean Section , Retrospective Studies
11.
Am J Obstet Gynecol MFM ; 5(4): 100877, 2023 04.
Article in English | MEDLINE | ID: mdl-36708967

ABSTRACT

BACKGROUND: The US Preventive Services Taskforce published guidelines in 2014 recommending that low-dose aspirin be initiated between 12 and 28 weeks of gestation among high-risk patients for preeclampsia prophylaxis. Moreover, low-dose aspirin is recommended by some clinicians for the prevention of preterm birth. OBJECTIVE: This study aimed to evaluate whether there is an association between the US Preventive Services Taskforce aspirin guideline hypertensive disorders of pregnancy and the rates of hypertensive disorders of pregnancy and preterm birth in individuals with pregestational diabetes mellitus. STUDY DESIGN: This was a repeated cross-sectional analysis of individuals with pregestational diabetes mellitus and at least 1 singleton delivery at >20 weeks of gestation with records available in the National Vital Statistics System between 2010 and 2018. The primary outcome was hypertensive disorders of pregnancy, and the secondary outcome was preterm birth. Demographics and clinical characteristics among individuals in the pre-US Preventive Services Taskforce guideline cohort (2010-2013) were compared with that of individuals in the post-US Preventive Services Taskforce guideline cohort (2015-2018). Multivariable regression estimated the odds ratios and 95% confidence intervals for the association between guideline publication and the selected endpoints. Effect modification was assessed for access to prenatal care using the Kotelchuck Index (<80% vs ≥80%). Furthermore, a sensitivity analysis limited to nulliparas was performed. RESULTS: Overall, 224,065 individuals were included. Individuals in the post-US Preventive Services Taskforce guideline cohort were more likely to be older, be obese, and have a history of preterm birth. In unadjusted and adjusted modeling, delivery in the post-US Preventive Services Taskforce guideline cohort was associated with hypertensive disorders of pregnancy (adjusted odds ratio, 1.25; 95% confidence interval, 1.22-1.28) and preterm birth (adjusted odds ratio, 1.10; 95% confidence interval, 1.08-1.12). The adjusted odds ratios for hypertensive disorders of pregnancy and preterm birth were more pronounced among those with less than adequate access to care. The findings were similar in the sensitivity analysis of only nulliparas. CONCLUSION: Delivery after US Preventive Services Taskforce aspirin guideline publication was associated with higher rates of hypertensive disorders of pregnancy and preterm birth in a population of individuals with diabetes mellitus. It is unknown whether patient or practitioner factors, or other changes in obstetrical care, contributed to these findings.


Subject(s)
Diabetes Mellitus , Hypertension, Pregnancy-Induced , Pregnancy in Diabetics , Premature Birth , Pregnancy , Female , Infant, Newborn , Humans , Platelet Aggregation Inhibitors/therapeutic use , Hypertension, Pregnancy-Induced/diagnosis , Hypertension, Pregnancy-Induced/epidemiology , Hypertension, Pregnancy-Induced/prevention & control , Premature Birth/epidemiology , Premature Birth/etiology , Premature Birth/prevention & control , Cross-Sectional Studies , Aspirin/therapeutic use , Pregnancy in Diabetics/diagnosis , Pregnancy in Diabetics/epidemiology , Pregnancy in Diabetics/drug therapy
12.
Obstet Gynecol ; 141(2): 395-402, 2023 02 01.
Article in English | MEDLINE | ID: mdl-36657144

ABSTRACT

OBJECTIVE: To evaluate whether there is an association between periviable delivery and new onset of or exacerbation of existing mental health disorders within 12 months postpartum. METHODS: We conducted a retrospective cohort study of individuals with liveborn singleton neonates delivered at 22 or more weeks of gestation from 2008 to 2017 in the MarketScan Commercial Research Database. The exposure was periviable delivery , defined as delivery from 22 0/7 through 25 6/7 weeks of gestation. The primary outcome was a mental health morbidity composite of one or more of the following: emergency department encounter associated with depression, anxiety, psychosis, posttraumatic stress disorder, adjustment disorder, self-harm, or suicide; new psychotropic medication prescription; new behavioral therapy visit; and inpatient psychiatry admission in the 12 months postdelivery. Secondary outcomes included components of the primary composite. Those with and without periviable delivery were compared using multivariable logistic regression adjusted for clinically relevant covariates, with results reported as adjusted incident rate ratios (aIRRs). Effect modification by history of mental health diagnoses was assessed. Incidence of the primary outcome by 90-day intervals postdelivery was assessed. RESULTS: Of 2,300,244 included deliveries, 16,275 (0.7%) were periviable. Individuals with periviable delivery were more likely to have a chronic health condition, to have undergone cesarean delivery, and to have experienced severe maternal morbidity. Periviable delivery was associated with a modestly increased risk of the primary composite outcome, occurring in 13.8% of individuals with periviable delivery and 11.0% of individuals without periviable delivery (aIRR 1.18, 95% CI 1.12-1.24). The highest-risk period for the composite primary outcome was the first 90 days in those with periviable delivery compared with those without periviable delivery (51.6% vs 42.4%; incident rate ratio 1.56, 95% CI 1.47-1.66). CONCLUSION: Periviable delivery was associated with a modestly increased risk of mental health morbidity in the 12 months postpartum.


Subject(s)
Mental Disorders , Mental Health , Pregnancy , Infant, Newborn , Female , Humans , Retrospective Studies , Cesarean Section , Mental Disorders/epidemiology , Postpartum Period
13.
J Perinatol ; 43(1): 34-38, 2023 01.
Article in English | MEDLINE | ID: mdl-36302848

ABSTRACT

OBJECTIVE: To estimate the individual physician cesarean delivery rate associated with serious perinatal morbidity. STUDY DESIGN: Study of nulliparous, term, singleton, vertex deliveries with maternal-neonatal dyad data (2015-2017) in the MarketScan Research Database. An individual cesarean delivery rate was calculated for all delivering physicians. The primary maternal outcome included transfusion of ≥4 units of blood, intensive care unit (ICU) admission, venous thromboembolism, or hysterectomy. The primary neonatal outcome included hypoxic ischemic encephalopathy, seizure, cardiopulmonary resuscitation or ventilator use (within 24 h), or ICU admission. Multivariable modeling of the association between physician cesarean delivery rate and each outcome was performed. RESULTS: Among 77,058 maternal-neonatal dyads, the maternal composite occurred in 1.3% of deliveries and neonatal composite in 3.6% of deliveries. The likelihood of the maternal (aOR 1.03 for each 3% increase in physician cesarean delivery rate, 95% CI 1.021-1.043) and neonatal (aOR 1.02 for each 3% increase, 95% CI 1.014-1.027) composite outcome increased linearly with increasing physician cesarean delivery rate. CONCLUSIONS: Severe perinatal morbidity was associated with increasing individual physician cesarean delivery rates.


Subject(s)
Cesarean Section , Delivery, Obstetric , Pregnancy , Infant, Newborn , Female , Humans , Retrospective Studies , Risk , Morbidity
14.
Obstet Gynecol ; 140(6): 989-992, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36357976

ABSTRACT

For public health research such as vaccine uptake or effectiveness assessments, self-reported coronavirus disease 2019 (COVID-19) vaccination status may be a more efficient measure than verifying vaccination status from medical records if agreement between sources is high. We assessed agreement between self-reported and medical record-documented COVID-19 vaccination status among pregnant individuals followed in a cohort during August 2020-October 2021. At end of pregnancy, participants completed questionnaires about COVID-19 vaccine receipt during pregnancy; staff verified vaccination status using medical records. Agreement was assessed between self-reported and medical record vaccination status using Cohen's kappa. There was high agreement between self-reported and medical record vaccination status (Kappa coefficient=0.94, 95% CI 0.91-0.98), suggesting that self-report may be acceptable for ascertaining COVID-19 vaccination status during pregnancy.


Subject(s)
COVID-19 , Pregnancy , Female , Humans , COVID-19/epidemiology , COVID-19/prevention & control , Self Report , COVID-19 Vaccines , Vaccination , Medical Records , Documentation
15.
Obstet Gynecol ; 140(5): 806-811, 2022 11 01.
Article in English | MEDLINE | ID: mdl-36201777

ABSTRACT

OBJECTIVE: To evaluate the association between prophylactic ureteral stent placement at the time of hysterectomy for placenta accreta spectrum and genitourinary injury. METHODS: We conducted a retrospective cohort study of patients with placenta accreta spectrum who underwent hysterectomy at two referral centers from 2001 to 2021. The exposure was prophylactic ureteral stent placement. The primary outcome, genitourinary injury, was a composite of bladder injury, ureteral injury, or vesicovaginal fistula. Secondary outcomes included components of the primary outcome. We evaluated differences between groups using χ 2 and t test. To evaluate differences in the primary outcome, we reported odds ratios (ORs) and adjusted odds ratios (aORs) using multivariable logistic regression analyses to control for potential confounding variables. We used a Cochran-Armitage χ 2 trend test to evaluate difference in stent use and injury over time. RESULTS: In total, 236 patients were included. Prophylactic ureteral stents were used in 156 surgeries (66%). Overall, genitourinary injury occurred less frequently in the stent group compared with the no stent group (28% vs 51%, OR 0.37, 95% CI 0.21-0.65). This association persisted after controlling for urgency of delivery, three or more prior cesarean deliveries, and whether a gynecologic oncologist was present (aOR 0.27, 95% CI 0.14-0.52). Unintentional bladder injury occurred less frequently in the stent group compared with the no stent group (13% vs 25%, P =.018), as did ureteral injury (2% vs 9%, P =.019). CONCLUSION: Prophylactic ureteral stent placement was associated with a decreased risk of genitourinary injury during hysterectomy for placenta accreta spectrum.


Subject(s)
Placenta Accreta , Humans , Pregnancy , Female , Placenta Accreta/surgery , Retrospective Studies , Hysterectomy/adverse effects , Cesarean Section , Urinary Bladder/surgery
16.
Obstet Gynecol ; 140(4): 575-583, 2022 10 01.
Article in English | MEDLINE | ID: mdl-36075079

ABSTRACT

OBJECTIVE: To evaluate fixed compared with weight-based enoxaparin dosing to achieve prophylactic anti-Xa levels after cesarean delivery. METHODS: Individuals meeting institutional criteria for enoxaparin thromboprophylaxis after cesarean delivery were randomly allocated to fixed (40 mg daily for body mass index [BMI, calculated as weight in kilograms divided by height in meters squared] lower than 40; 40 mg every 12 hours for BMI 40 or higher) or weight-based (0.5 mg/kg every 12 hours) enoxaparin dosing. Enoxaparin was initiated during inpatient hospitalization and continued at discharge for 14 days. Those with contraindication to anticoagulation, plan for therapeutic anticoagulation, or known renal impairment were excluded. The trial was unmasked. The primary outcome was prophylactic (0.2-0.6 international units/mL) peak anti-Xa level 4-6 hours after at least the third enoxaparin dose (at steady state). Secondary outcomes included subprophylactic and supraprophylactic peaks, outpatient peak, and venous thromboembolism (VTE) and wound complications in the first 6 weeks postpartum. Sample size of 121 per group was planned. At interim analysis with 50% enrollment, the trial was stopped early for efficacy. Primary analyses followed intention-to-treat principle with worst-case imputation for missing outcomes. Secondary analyses were complete case. RESULTS: From June 2020 to November 2021, 74 individuals were randomized to weight-based enoxaparin and 72 to fixed-dose enoxaparin. Those who received weight-based dosing were more likely to achieve prophylactic anti-Xa levels than those who received fixed dosing in primary analysis (49/74 [66%] vs 32/72 [44%], relative risk [RR] 1.49, 95% CI 1.10-2.02) and secondary analysis (49/60 [82%] vs 32/57 [56%], RR 1.45, 95% CI 1.12-1.88). Subprophylactic levels occurred more frequently with fixed dosing; supraprophylactic levels did not differ significantly by dosing. At the outpatient postoperative visit, 52% of participants (15/29) with weight-based dosing compared with 15% (5/33) with fixed dosing achieved prophylactic peak anti-Xa level (RR 3.41, 95% CI 1.42-8.24). There were no VTEs in either group. Wound complications occurred in five individuals (7%) with weight-based enoxaparin dosing compared with one individual (1%) with fixed enoxaparin dosing (RR 4.86, 95% 0.58-40.63). CONCLUSION: Weight-based dosing was more effective than fixed enoxaparin dosing in achieving prophylactic peak anti-Xa levels after cesarean delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04305756.


Subject(s)
Enoxaparin , Venous Thromboembolism , Pregnancy , Female , Humans , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Anticoagulants/therapeutic use , Cesarean Section/adverse effects , Blood Coagulation
17.
Obstet Gynecol ; 140(3): 399-407, 2022 09 01.
Article in English | MEDLINE | ID: mdl-35930389

ABSTRACT

After the global cesarean delivery rate nearly doubled between 2000 and 2015, cesarean deliveries now account for nearly one third of births in the United States. Although rates have plateaued, the high national cesarean delivery rate has garnered criticism from both lay and academic communities because it has not been associated with improvements in maternal or neonatal outcomes. Efforts are underway to lower the cesarean delivery rate through implementation of hospital-level and national guidelines. However, the cesarean delivery rate that optimizes maternal and neonatal outcomes is not known. Defining a cesarean delivery rate that optimizes perinatal outcomes and reduces morbidity seems simple. However, there are a host of challenges to such a task, including determining the outcomes that are most meaningful to use, deciding the population that should define the rate, and incorporating person-centered decision making, given that people place different value on different outcomes. Rather than a "call" for cesarean delivery rate reductions of a specific and arbitrary magnitude, we need further attention to defining an evidence-based optimal target. This commentary summarizes current national and international cesarean delivery rate targets, discusses the challenges of identifying an evidence-based national cesarean delivery rate target, and explores future considerations for best defining a cesarean delivery rate target.


Subject(s)
Cesarean Section , Parturition , Infant, Newborn , Pregnancy , Female , United States , Humans , Hospitals , Morbidity
18.
Obstet Gynecol ; 140(1): 83-86, 2022 07 01.
Article in English | MEDLINE | ID: mdl-35849460

ABSTRACT

Hypertensive disorders of pregnancy affect up to 8% of pregnancies, but updated national trends are lacking. We performed a repeated cross-sectional analysis of individuals with singleton pregnancies who delivered at greater than 20 weeks of gestation, with data in the U.S. National Vital Statistics System from 1989 to 2020. Temporal trends in hypertensive disorders of pregnancy, chronic hypertension, and eclampsia were characterized using joinpoint regression. Overall, 122,329,914 deliveries were included. Hypertensive disorders of pregnancy increased from 2.79% in 1989 to 8.22% in 2020, representing an average annual percentage change (AAPC) of 3.6% (95% CI 3.0-4.1%). Chronic hypertension increased (AAPC 4.1%, 95% CI 3.3-4.9%), whereas eclampsia decreased (AAPC -2.5%, 95% CI -4.0% to -1.0%). Hypertensive disorders of pregnancy are associated with significant morbidity and mortality; the rising incidence is concerning.


Subject(s)
Eclampsia , Hypertension, Pregnancy-Induced , Pre-Eclampsia , Vital Statistics , Cross-Sectional Studies , Eclampsia/epidemiology , Female , Humans , Hypertension, Pregnancy-Induced/epidemiology , Hypertension, Pregnancy-Induced/etiology , Incidence , Pre-Eclampsia/epidemiology , Pregnancy , United States/epidemiology
19.
Am J Perinatol ; 39(16): 1719-1725, 2022 12.
Article in English | MEDLINE | ID: mdl-35709739

ABSTRACT

OBJECTIVE: Physical examination-indicated cerclage for cervical insufficiency prolongs gestation, but evidence on the addition of adjuncts to further prolong latency is limited. The aim of this systematic review and meta-analysis was to compare gestational latency between those who did and did not receive adjunct antibiotic or tocolytic therapy at the time of examination-indicated cerclage. STUDY DESIGN: Electronic databases (1966-2020) were searched for randomized controlled trials (RCTs) and cohort studies comparing adjunct antibiotic or tocolytic use versus nonuse at time of examination-indicated cerclage, defined as placement for cervical dilation ≥1 cm, in a current singleton pregnancy. Studies including individuals with intra-amniotic infection, cerclage in place, nonviable gestation, or ruptured membranes were excluded. The primary outcome was latency from cerclage placement to delivery. Secondary outcomes included preterm birth, preterm premature rupture of membranes, birth weight, and neonatal survival. Risk of bias was assessed using standardized tools. Heterogeneity was assessed using χ 2 and I 2 tests. Results were pooled and analyzed using a random-effects model. This study is registered with The International Prospective Register of Systematic Reviews (PROSPERO) with registration no.: CRD42021216370. RESULTS: Of 923 unique records, 163 were reviewed in full. Three met inclusion criteria: one RCT and two retrospective cohorts. The included RCT (n = 50) and one cohort (n = 142) compared outcomes with and without adjunct use of antibiotic and tocolytic, while the second cohort (n = 150) compared outcomes with and without adjunct tocolytic, with a subpopulation also receiving antibiotics. The RCT was nested within one of the cohorts, and therefore only one of these two studies was utilized for any given outcome to eliminate counting individuals twice. Risk of bias was "critical" for one cohort study, "moderate" for the other cohort study, and "some concerns" for the RCT. Gestational latency could not be pooled and meta-analyzed. Adjunct tocolytic-antibiotic therapy was not associated with a decrease in risk of preterm delivery <28 weeks (relative risk [RR] = 0.90, 95% confidence interval [CI]: 0.65-1.26; χ 2 = 0.0, I 2 = 0.0%) or neonatal survival to discharge (RR = 1.11, 95% CI: 0.91-1.35; χ 2 = 0.05, I 2 = 0.0%). CONCLUSION: There is not enough evidence to robustly evaluate the use of adjunct tocolytics or antibiotics at time of examination-indicated cerclage to prolong latency. KEY POINTS: · Limited data on adjunct antibiotic tocolytics at cerclage.. · Widely variable practices at time of cerclage identified.. · Role of adjunct therapies at time of examination-indicated cerclage remains unclear..


Subject(s)
Cerclage, Cervical , Premature Birth , Tocolytic Agents , Humans , Pregnancy , Infant, Newborn , Female , Cerclage, Cervical/methods , Tocolytic Agents/therapeutic use , Premature Birth/prevention & control , Anti-Bacterial Agents/therapeutic use , Combined Modality Therapy
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