Publications by authors named "Donald Coustan"

61 Publications

One-step or two-step testing for gestational diabetes mellitus: which is best?

Am J Obstet Gynecol 2021 May 21. Epub 2021 May 21.

Department of Medicine (Endocrinology), Northwestern University Feinberg School of Medicine, Chicago, IL.

In the United States, the common approach to detecting gestational diabetes mellitus is the 2-step protocol recommended by the American College of Obstetricians and Gynecologists. A 50 g, 1-hour glucose challenge at 24 to 28 weeks' gestation is followed by a 100 g, 3-hour oral glucose tolerance test when a screening test threshold is exceeded. Notably, 2 or more elevated values diagnose gestational diabetes mellitus. The 2-step screening test is administered without regard to the time of the last meal, providing convenience by eliminating the requirement for fasting. However, depending upon the cutoff used and population risk factors, approximately 15% to 20% of screened women require the 100 g, 3-hour oral glucose tolerance test. The International Association of Diabetes and Pregnancy Study Groups recommends a protocol of no screening test but rather a diagnostic 75 g, 2-hour oral glucose tolerance test. One or more values above threshold diagnose gestational diabetes mellitus. The 1-step approach requires that women be fasting for the test but does not require a second visit and lasts 2 hours rather than 3. Primarily because of needing only a single elevated value, the 1-step approach identifies 18% to 20% of pregnant women as having gestational diabetes mellitus, 2 to 3 times the rate with the 2-step procedure, but lower than the current United States prediabetes rate of 24% in reproductive aged women. The resources needed for the increase in gestational diabetes mellitus are parallel to the resources needed for the increased prediabetes and diabetes in the nonpregnant population. A recent randomized controlled trial sought to assess the relative population benefits of the above 2 approaches to gestational diabetes mellitus screening and diagnosis. The investigators concluded that there was no significant difference between the 2-step screening protocol and 1-step diagnostic testing protocol in their impact on population adverse short-term pregnancy outcomes. An accompanying editorial concluded that perinatal benefits of the 1-step approach to diagnosing gestational diabetes mellitus "appear to be insufficient to justify the associated patient and healthcare costs of broadening the diagnosis." We raise several concerns about this conclusion. The investigators posited that a 20% improvement in adverse outcomes among the entire pregnancy cohort would be necessary to demonstrate an advantage to the 1-step approach and estimated the sample size based on that presumption, which we believe to be unlikely given the number of cases that would be identified. In addition, 27% of the women randomized to the 1-step protocol underwent 2-step testing; 6% of the study cohort had no testing at all. A subset of women assigned to 2-step testing did not meet the criteria for gestational diabetes mellitus but were treated as such because of elevated fasting plasma glucose levels, presumably contributing to the reduction in adverse outcomes but not to the number of gestational diabetes mellitus identified, increasing the apparent efficacy of the 2-step approach. No consideration was given to long-term benefits for mothers and offspring. All these factors may have contributed to obscuring the benefits of 1-step testing; most importantly, the study was not powered to identify what we understand to be the likely impact of 1-step testing on population health.
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http://dx.doi.org/10.1016/j.ajog.2021.05.009DOI Listing
May 2021

Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional.

Trials 2021 Apr 7;22(1):256. Epub 2021 Apr 7.

Weight Control and Diabetes Research Center, The Miriam Hospital, Providence, USA.

Background: Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence.

Methods: The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures.

Discussion: The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks.

Trial Registration: ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.
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http://dx.doi.org/10.1186/s13063-021-05204-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8024941PMC
April 2021

Hyperglycemia and Adverse Pregnancy Outcomes.

Clin Chem 2019 07 17;65(7):937-938. Epub 2019 Apr 17.

Centre for Public Health, Queen's University of Belfast, Belfast, UK.

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http://dx.doi.org/10.1373/clinchem.2019.303990DOI Listing
July 2019

Maternal BMI, Peripheral Deiodinase Activity, and Plasma Glucose: Relationships Between White Women in the HAPO Study.

J Clin Endocrinol Metab 2019 07;104(7):2593-2600

Department of Pathology and Laboratory Medicine, Women and Infants Hospital, Providence, Rhode Island.

Objectives: Explore the maternal body mass index (BMI) relationship with peripheral deiodinase activity further. Examine associations between deiodinase activity, glucose, and C-peptide. Consider findings in the historical context of related existing literature.

Design: Identify fasting plasma samples and selected demographic, biophysical, and biochemical data from a subset of 600 randomly selected non-Hispanic white women recruited in the Hyperglycemia Adverse Pregnancy Outcomes (HAPO) study, all with glucose tolerance testing [545 samples sufficient to measure TSH, free T4 (fT4), and T3]. Exclude highest and lowest 1% TSH values (535 available for analysis). Assess deiodinase activity by using T3/fT4 ratios. Among women with and without gestational diabetes mellitus (GDM), compare thyroid measurements, C-peptide, and other selected data. Examine relationships independent of GDM status between BMI and thyroid hormones and between thyroid hormones and glucose and C-peptide.

Results: Levels of BMI, T3/fT4 ratio, and T3 were significantly higher among women with GDM (P = 0.01, 0.005, and 0.001, respectively). Irrespective of GDM status, maternal BMI was associated directly with both T3/fT4 ratio (r = 0.40, P < 0.001) and T3 (r = 0.34, P < 0.001) but inversely with fT4 (r = -0.21, P < 0.001). In turn, fasting thyroid hormone levels (most notably T3/fT4 ratio) were directly associated with maternal glucose [z score sum (fasting, 1, 2 hours); r = 0.24, P < 0.001] and with C-peptide [z score sum (fasting, 1 hour); r = 0.27, P < 0.001].

Conclusions: Higher BMI was associated with increased deiodinase activity, consistent with reports from elsewhere. Increased deiodinase activity, in turn, was associated with higher glucose. Deiodinase activity accounts for a small percentage of z score sum glucose.
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http://dx.doi.org/10.1210/jc.2018-02328DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453035PMC
July 2019

Research Gaps in Gestational Diabetes Mellitus: Executive Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

Obstet Gynecol 2018 08;132(2):496-505

Diabetes Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; the Divisions of Endocrinology, Metabolism, and Diabetes and Maternal-Fetal Medicine, University of Colorado School of Medicine and Anschutz Medical Campus, Aurora, Colorado; the Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California; Women & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, Rhode Island; the Diabetes Unit, Hospital de la Santa Creu I Sant Pau, Universitat Autonoma de Barcelona, Bellaterra, Barcelona, CIBER-BBN, Spain; the Center for Pregnant Women with Diabetes, Department of Obstetrics, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; College Medicine Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland; the Diabetes & Endocrine in Pregnancy Program, Mount Sinai Hospital and University of Toronto, Toronto, Canada; the Division of Research, Kaiser Permanente Northern California, Oakland, California; the Department of Maternal-Fetal Medicine, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio; the Departments of Medicine and Obstetrics and Gynecology, McGill University Health Centre, Montreal, Quebec, Canada; Northwestern University Feinberg School of Medicine, Chicago, Illinois; Kaiser Permanente Southern California, San Diego, California; National Women's Health, Auckland, New Zealand; the Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; Campbelltown Hospital and Western Sydney University, Sydney, Australia; MedStar Health Research Institute, Hyattsville, Maryland; Georgetown-Howard Universities Center for Clinical and Translational Science, Washington, DC; and the Center for Reproductive Health, Case Western Reserve University at MetroHealth Medical Center, Cleveland, Ohio.

The National Institute of Diabetes and Digestive and Kidney Diseases convened a workshop on research gaps in gestational diabetes mellitus (GDM) with a focus on 1) early pregnancy diagnosis and treatment and 2) pharmacologic treatment strategies. This article summarizes the proceedings of the workshop. In early pregnancy, the appropriate diagnostic criteria for the diagnosis of GDM remain poorly defined, and an effect of early diagnosis and treatment on the risk of adverse outcomes has not been demonstrated. Despite many small randomized controlled trials of glucose-lowering medication treatment in GDM, our understanding of medication management of GDM is incomplete as evidenced by discrepancies among professional society treatment guidelines. The comparative effectiveness of insulin, metformin, and glyburide remains uncertain, particularly with respect to long-term outcomes. Additional topics in need of further research identified by workshop participants included phenotypic heterogeneity in GDM and novel and individualized treatment approaches. Further research on these topics is likely to improve our understanding of the pathophysiology and treatment of GDM to improve both short- and long-term outcomes for mothers and their children.
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http://dx.doi.org/10.1097/AOG.0000000000002726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6124493PMC
August 2018

A cautionary response to SMFM statement: pharmacological treatment of gestational diabetes.

Am J Obstet Gynecol 2018 10 28;219(4):367.e1-367.e7. Epub 2018 Jun 28.

Section on Islet Cell and Regenerative Biology, Joslin Diabetes Center, Department of Medicine, Harvard Medical School, Boston, MA.

Use of oral agents to treat gestational diabetes mellitus remains controversial. Recent recommendations from the Society for Maternal-Fetal Medicine assert that metformin may be a safe first-line alternative to insulin for gestational diabetes mellitus treatment and preferable to glyburide. However, several issues should give pause to the widespread adoption of metformin use during pregnancy. Fetal concentrations of metformin are equal to maternal, and metformin can inhibit growth, suppress mitochondrial respiration, have epigenetic modifications on gene expression, mimic fetal nutrient restriction, and alter postnatal gluconeogenic responses. Because both the placenta and fetus express metformin transporters and exhibit high mitochondrial activity, these properties raise important questions about developmental programming of metabolic disease in offspring. Animal studies have demonstrated that prenatal metformin exposure results in adverse long-term outcomes on body weight and metabolism. Two recent clinical randomized controlled trials in women with gestational diabetes mellitus or polycystic ovary syndrome provide evidence that metformin exposure in utero may produce a metabolic phenotype that increases childhood weight or obesity. These developmental programming effects challenge the conclusion that metformin is equivalent to insulin. Although the Society for Maternal-Fetal Medicine statement endorsed metformin over glyburide if oral agents are used, there are few studies directly comparing the 2 agents and it is not clear that metformin alone is superior to glyburide. Moreover, it should be noted that prior clinical studies have dosed glyburide in a manner inconsistent with its pharmacokinetic properties, resulting in poor glycemic control and high rates of maternal hypoglycemia. We concur with the American Diabetes Association and American Congress of Obstetricians and Gynecologists, which recommend insulin as the preferred agent, but we believe that it is premature to embrace metformin as equivalent to insulin or superior to glyburide. Due to the uncertainty of the long-term metabolic risks of either metformin or glyburide, we call for carefully controlled studies that optimize oral medication dosing according to their pharmacodynamic and pharmacokinetic properties in pregnancy, appropriately target medications based on individual patterns of hyperglycemia, and follow the offspring long-term for metabolic risk.
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http://dx.doi.org/10.1016/j.ajog.2018.06.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6263936PMC
October 2018

Insulin vs Glyburide for Gestational Diabetes.

JAMA 2018 05;319(17):1769-1770

Divisions of Endocrinology, Diabetes and Metabolism, and Maternal-Fetal Medicine, University of Colorado School of Medicine, Aurora.

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http://dx.doi.org/10.1001/jama.2018.4561DOI Listing
May 2018

Stillbirth, Inflammatory Markers, and Obesity: Results from the Stillbirth Collaborative Research Network.

Am J Perinatol 2018 09 2;35(11):1071-1078. Epub 2018 Apr 2.

Columbia University Medical Center, New York, New York.

Background: Obesity is associated with increased risk of stillbirth, although the mechanisms are unknown. Obesity is also associated with inflammation. Serum ferritin, C-reactive protein, white blood cell count, and histologic chorioamnionitis are all markers of inflammation.

Objective: This article determines if inflammatory markers are associated with stillbirth and body mass index (BMI). Additionally, we determined whether inflammatory markers help to explain the known relationship between obesity and stillbirth.

Study Design: White blood cell count was assessed at admission to labor and delivery, maternal serum for assessment of various biomarkers was collected after study enrollment, and histologic chorioamnionitis was based on placental histology. These markers were compared for stillbirths and live births overall and within categories of BMI using analysis of variance on logarithmic-transformed markers and logistic regression for dichotomous variables. The impact of inflammatory markers on the association of BMI categories with stillbirth status was assessed using crude and adjusted odds ratios (COR and AOR, respectively) from logistic regression models. The interaction of inflammatory markers and BMI categories on stillbirth status was also assessed through logistic regression. Additional logistic regression models were used to determine if the association of maternal serum ferritin with stillbirth is different for preterm versus term births. Analyses were weighted for the overall population from which this sample was derived.

Results: A total of 497 women with singleton stillbirths and 1,414 women with live births were studied with prepregnancy BMI (kg/m) categorized as normal (18.5-24.9), overweight (25.0-29.9), or obese (30.0 + ). Overweight (COR, 1.48; 95% confidence interval [CI]: 1.14-1.94) and obese women (COR, 1.60; 95% CI: 1.23-2.08) were more likely than normal weight women to experience stillbirth. Serum ferritin levels were higher (geometric mean: 37.4 ng/mL vs. 23.3,  < 0.0001) and C-reactive protein levels lower (geometric mean: 2.9 mg/dL vs. 3.3,  = 0.0279), among women with stillbirth compared with live birth. Elevated white blood cell count (15.0 uL × 10 or greater) was associated with stillbirth (21.2% SB vs. 10.0% live birth,  < 0.0001). Histologic chorioamnionitis was more common (33.2% vs. 15.7%,  < 0.0001) among women with stillbirth compared with those with live birth. Serum ferritin, C-reactive protein, and chorioamnionitis had little impact on the ORs associating stillbirth with overweight or obesity. Adjustment for elevated white blood cell count did not meaningfully change the OR for stillbirth in overweight versus normal weight women. However, the stillbirth OR for obese versus normal BMI changed by more than 10% when adjusting for histologic chorioamnionitis (AOR, 1.38; 95% CI: 1.02-1.88), indicating confounding. BMI by inflammatory marker interaction terms were not significant. The association of serum ferritin levels with stillbirth was stronger among preterm births ( = 0.0066).

Conclusion: Maternal serum ferritin levels, elevated white blood cell count, and histologic chorioamnionitis were positively and C-reactive protein levels negatively associated with stillbirth. Elevated BMIs, both overweight and obese, were associated with stillbirth when compared with women with normal BMI. None of the inflammatory markers fully accounted for the relationship between obesity and stillbirth. The association of maternal serum ferritin with stillbirth was stronger in preterm than term stillbirths.
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http://dx.doi.org/10.1055/s-0038-1639340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436964PMC
September 2018

Potentially Preventable Stillbirth in a Diverse U.S. Cohort.

Obstet Gynecol 2018 02;131(2):336-343

University of Utah School of Medicine, Salt Lake City, Utah; RTI International, Research Triangle Park, North Carolina; Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; the University of Virginia. Charlottesville, Virginia; Rollins School of Public Health, Emory University, Atlanta, Georgia; the University of Texas Medical Branch at Galveston, Galveston, Texas; Brown University School of Medicine, Providence, Rhode Island; the University of Texas Health Science Center at San Antonio, San Antonio, Texas; McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas; the University of Texas Health Science Center at Austin, Austin, Texas; and Columbia University, New York, New York.

Objective: To estimate the proportion of potentially preventable stillbirths in the United States.

Methods: We conducted a secondary analysis of 512 stillbirths with complete evaluation enrolled in the Stillbirth Collaborative Research Network from 2006 to 2008. The Stillbirth Collaborative Research Network was a multisite, geographically, racially, and ethnically diverse, population-based case-control study of stillbirth in the United States. Cases of stillbirth underwent standard evaluation that included maternal interview, medical record abstraction, biospecimen collection, postmortem examination, placental pathology, and clinically recommended evaluation. Each stillbirth was assigned probable and possible causes of death using the Initial Causes of Fetal Death algorithm system. For this analysis, we defined potentially preventable stillbirths as those occurring in nonanomalous fetuses, 24 weeks of gestation or greater, and weighing 500 g or greater that were 1) intrapartum, 2) the result of medical complications, 3) the result of placental insufficiency, 4) multiple gestation (excluding twin-twin transfusion), 5) the result of spontaneous preterm birth, or 6) the result of hypertensive disorders of pregnancy.

Results: Of the 512 stillbirths included in our cohort, causes of potentially preventable stillbirth included placental insufficiency (65 [12.7%]), medical complications of pregnancy (31 [6.1%]), hypertensive disorders of pregnancy (20 [3.9%]), preterm labor (16 [3.1%]), intrapartum (nine [1.8%]), and multiple gestations (four [0.8%]). Twenty-seven stillbirths fit two or more categories, leaving 114 (22.3%) potentially preventable stillbirths.

Conclusion: Based on our definition, almost one fourth of stillbirths are potentially preventable. Given the predominance of placental insufficiency among stillbirths, identification and management of placental insufficiency may have the most immediate effect on stillbirth reduction.
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http://dx.doi.org/10.1097/AOG.0000000000002421DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785410PMC
February 2018

Gestational Diabetes Mellitus: Why the Controversy?

Clin Chem 2018 03 11;64(3):431-438. Epub 2017 Oct 11.

Professor of Obstetrics and Gynecology, The Sackler Faculty of Medicine, Tel Aviv University, Helen Schneider's Hospital for Women, Rabin Medical Center, Petah-Tikva, Israel, President, European Association of Perinatal Medicine (EAPM), Chairman, FIGO Hyperglycemia in Pregnancy (HIP) Working Group.

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http://dx.doi.org/10.1373/clinchem.2016.266577DOI Listing
March 2018

Altered fetal growth, placental abnormalities, and stillbirth.

PLoS One 2017 18;12(8):e0182874. Epub 2017 Aug 18.

Columbia University Medical Center, New York, New York, United States of America.

Background: Worldwide, stillbirth is one of the leading causes of death. Altered fetal growth and placental abnormalities are the strongest and most prevalent known risk factors for stillbirth. The aim of this study was to identify patterns of association between placental abnormalities, fetal growth, and stillbirth.

Methods And Findings: Population-based case-control study of all stillbirths and a representative sample of live births in 59 hospitals in 5 geographic areas in the U.S. Fetal growth abnormalities were categorized as small (<10th percentile) and large (>90th percentile) for gestational age at death (stillbirth) or delivery (live birth) using a published algorithm. Placental examination by perinatal pathologists was performed using a standardized protocol. Data were weighted to account for the sampling design. Among 319 singleton stillbirths and 1119 singleton live births at ≥24 weeks at death or delivery respectively, 25 placental findings were investigated. Fifteen findings were significantly associated with stillbirth. Ten of the 15 were also associated with fetal growth abnormalities (single umbilical artery; velamentous insertion; terminal villous immaturity; retroplacental hematoma; parenchymal infarction; intraparenchymal thrombus; avascular villi; placental edema; placental weight; ratio birth weight/placental weight) while 5 of the 15 associated with stillbirth were not associated with fetal growth abnormalities (acute chorioamnionitis of placental membranes; acute chorioamionitis of chorionic plate; chorionic plate vascular degenerative changes; perivillous, intervillous fibrin, fibrinoid deposition; fetal vascular thrombi in the chorionic plate). Five patterns were observed: placental findings associated with (1) stillbirth but not fetal growth abnormalities; (2) fetal growth abnormalities in stillbirths only; (3) fetal growth abnormalities in live births only; (4) fetal growth abnormalities in stillbirths and live births in a similar manner; (5) a different pattern of fetal growth abnormalities in stillbirths and live births.

Conclusions: The patterns of association between placental abnormalities, fetal growth, and stillbirth provide insights into the mechanism of impaired placental function and stillbirth. They also suggest implications for clinical care, especially for placental findings amenable to prenatal diagnosis using ultrasound that may be associated with term stillbirths.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0182874PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5562325PMC
October 2017

Insulin Delivery Method and Admission for Glycemic Control in Pregnant Women with Type 1 Diabetes Mellitus.

Am J Perinatol 2018 Feb 14;35(3):209-214. Epub 2017 Jul 14.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital of Rhode Island, Providence, Rhode Island.

Objective:  To determine if there was a difference in glycemic control admissions or perinatal outcomes in women with type 1 diabetes mellitus (DM) treated with multiple daily injections (MDIs) versus continuous subcutaneous insulin infusion (CSII).

Materials And Methods:  This was a retrospective cohort study of women with type 1 DM with a singleton gestation who delivered between 2006 and 2014 at a tertiary hospital and received care at a dedicated DM clinic. Women who used MDI were compared with those who used CSII. The primary outcome was glycemic control admission during pregnancy. Secondary outcomes included adverse perinatal outcomes.

Results:  There were a total of 156 women; 107 treated with MDI and 49 with CSII. Women treated with MDI had higher rates of glycemic control admissions versus those treated with CSII (68.2 vs. 30.6%,  < 0.001). Adjusting for age, ethnicity, public insurer, duration of DM, first recorded hemoglobin A1c (HbA1c), and DM comorbidities, the likelihood of admission remained higher in women on MDI versus CSII (AOR 5.9 [1.7-20.6]). Women treated with MDI had higher rates of postprandial hypoglycemia. Other perinatal outcomes were similar between the groups.

Conclusion:  Women with type 1 DM treated with MDI were more likely to have glycemic control admissions and postprandial hypoglycemia than those treated with CSII.
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http://dx.doi.org/10.1055/s-0037-1604196DOI Listing
February 2018

Prenatal Care Adherence and Neonatal Intensive Care Unit Admission or Stillbirth among Women with Gestational and Preexisting Diabetes Mellitus.

Am J Perinatol 2018 Jan 15;35(2):103-109. Epub 2017 May 15.

Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Brown University Warren Alpert Medical School, Providence, Rhode Island.

Objective:  To determine if there was an association between prenatal care adherence and neonatal intensive care unit (NICU) admission or stillbirth, and adverse perinatal outcomes in women with preexisting diabetes mellitus (DM) and gestational DM (GDM).

Materials And Methods:  This is a retrospective cohort study among women with DM and GDM at a Diabetes in Pregnancy Program at an academic institution between 2006 and 2014. Adherence with prenatal care was the percentage of prenatal appointments attended divided by those scheduled. Adherence was divided into quartiles, with the first quartile defined as lower adherence and compared with the other quartiles.

Results:  There were 443 women with DM and 499 with GDM. Neonates of women with DM and lower adherence had higher rates of NICU admission or stillbirth (55 vs. 39%;  = 0.003). A multivariable logistic regression showed that the lower adherence group had higher likelihood of NICU admission (adjusted odds ratio: 1.61 [1.03-2.5];  = 0.035). Those with lower adherence had worse glycemic monitoring and more hospitalizations. Among those with GDM, most outcomes were similar between groups including NICU admission or stillbirth.

Conclusion:  Women with DM with lower adherence had higher rates of NICU admission and worse glycemic control. Most outcomes among women with GDM with lower adherence were similar.
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http://dx.doi.org/10.1055/s-0037-1603343DOI Listing
January 2018

Diagnostic Tests for Evaluation of Stillbirth: Results From the Stillbirth Collaborative Research Network.

Obstet Gynecol 2017 04;129(4):699-706

University of Utah School of Medicine and Intermountain Health Care, Salt Lake City, Utah; Rollins School of Public Health, Emory University, Atlanta, Georgia; RTI International, Research Triangle Park, North Carolina; the Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; the University of Texas Health Science Center at San Antonio, San Antonio, and the University of Texas Medical Branch at Galveston, Galveston, Texas; Brown University School of Medicine, Providence, Rhode Island; and Columbia University, New York, New York.

Objective: To estimate the usefulness of each diagnostic test in the work-up for potential causes of stillbirth.

Methods: A secondary analysis of 512 stillbirths enrolled in the Stillbirth Collaborative Research Network from 2006 to 2008 was performed. The Stillbirth Collaborative Research Network was a multisite, geographically, racially, and ethnically diverse, population-based study of stillbirth in the United States. Participants underwent standardized evaluations that included maternal interview, medical record abstraction, biospecimen collection, fetal autopsy, and placental pathology. Also, most participants had a clinical work-up that included karyotype, toxicology screen, syphilis serology, antibody screen, fetal-maternal hemorrhage testing, and testing for antiphospholipid antibodies as well as testing performed on biospecimens for research purposes. Previously, each participant had been assigned probable and possible causes of death using the Initial Causes of Fetal Death classification system. In this analysis, tests were considered useful if a positive result established (or helped to establish) this cause of death or a negative result excluded a cause of death that was suspected based on the clinical history or other results.

Results: The usefulness of each test was as follows: placental pathology 64.6% (95% confidence interval [CI] 57.9-72.0), fetal autopsy 42.4% (95% CI 36.9-48.4), genetic testing 11.9% (95% CI 9.1-15.3), testing for antiphospholipid antibodies 11.1% (95% CI 8.4-14.4), fetal-maternal hemorrhage 6.4% (95% CI 4.4-9.1), glucose screen 1.6% (95% CI 0.7-3.1), parvovirus 0.4% (95% CI 0.0-1.4), and syphilis 0.2% (95% CI 0.0-1.1). The utility of the tests varied by clinical presentation, suggesting a customized approach for each patient.

Conclusion: The most useful tests were placental pathology and fetal autopsy followed by genetic testing and testing for antiphospholipid antibodies.
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http://dx.doi.org/10.1097/AOG.0000000000001937DOI Listing
April 2017

An ounce of prevention….

Authors:
Donald R Coustan

Am J Obstet Gynecol 2017 04 27;216(4):338-339. Epub 2017 Feb 27.

Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, and Women & Infants Hospital of Rhode Island, Providence, RI. Electronic address:

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http://dx.doi.org/10.1016/j.ajog.2017.01.024DOI Listing
April 2017

Recurrent GDM and the development of type 2 diabetes have similar risk factors.

Authors:
Donald R Coustan

Endocrine 2016 09 9;53(3):624-5. Epub 2016 Jul 9.

Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Providence, RI 02903, USA.

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http://dx.doi.org/10.1007/s12020-016-1016-4DOI Listing
September 2016

Factor V Leiden, prothrombin G20210A, and methylene tetrahydrofolate reductase mutations and stillbirth: the Stillbirth Collaborative Research Network.

Am J Obstet Gynecol 2016 10 27;215(4):468.e1-468.e17. Epub 2016 Apr 27.

Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.

Background: An evaluation for heritable thrombophilias is recommended in the evaluation of stillbirth. However, the association between thrombophilias and stillbirth remains uncertain.

Objective: We sought to assess the association between maternal and fetal/placental heritable thrombophilias and stillbirth in a population-based, case-control study in a geographically, racially, and ethnically diverse population.

Study Design: We conducted secondary analysis of data from the Stillbirth Collaborative Research Network, a population-based case-control study of stillbirth. Testing for factor V Leiden, prothrombin G20210A, methylene tetrahydrofolate reductase C677T and A1298C, and plasminogen activating inhibitor (PAI)-1 4G/5G mutations was done on maternal and fetal (or placental) DNA from singleton pregnancies. Data analyses were weighted for oversampling and other aspects of the design. Odds ratios (OR) were generated from univariate models regressing stillbirth/live birth status on each thrombophilia marker.

Results: Results were available for ≥1 marker in 488 stillbirths and 1342 live birth mothers and 405 stillbirths and 990 live birth fetuses. There was an increased odds of stillbirth for maternal homozygous factor V Leiden mutation (2/488; 0.4% vs 1/1380; 0.0046%; OR, 87.44; 95% confidence interval, 7.88-970.92). However, there were no significant differences in the odds of stillbirth for any other maternal thrombophilia, even after stratified analyses. Fetal 4G/4G PAI-1 (OR, 0.63; 95% confidence interval, 0.43-0.91) was associated with decreased odds of stillbirth. Other fetal thrombophilias were similar among groups.

Conclusion: Most maternal and fetal thrombophilias were not associated with stillbirth. Maternal factor V Leiden was weakly associated with stillbirth, and the fetal PAI-1 4G/4G polymorphism was associated with live birth. Our data do not support routine testing for heritable thrombophilias as part of an evaluation for possible causes of stillbirth.
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http://dx.doi.org/10.1016/j.ajog.2016.04.026DOI Listing
October 2016

Re: Follow-up of women with previous gestational diabetes.

Authors:
Donald R Coustan

Acta Diabetol 2016 Feb 27;53(1):133. Epub 2015 Jun 27.

Warren Alpert Medical School of Brown University, Providence, RI, USA.

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http://dx.doi.org/10.1007/s00592-015-0773-5DOI Listing
February 2016

The association of stillbirth with depressive symptoms 6-36 months post-delivery.

Paediatr Perinat Epidemiol 2015 Mar 14;29(2):131-43. Epub 2015 Feb 14.

School of Public Health and School of Medicine, Emory University, Atlanta, GA.

Background: Stillbirths (≥ 20 weeks' gestation), which account for about 1 in 200 US pregnancies, may grieve parents deeply. Unresolved grief may lead to persistent depression.

Methods: We compared depressive symptoms in 2009 (6-36 months after index delivery) among consenting women in the Stillbirth Collaborative Research Network's population-based case-control study conducted 2006-08 (n = 275 who delivered a stillbirth and n = 522 who delivered a healthy livebirth (excluding livebirths < 37 weeks, infants who had been admitted to a neonatal intensive care unit or who died). Women scoring > 12 on the Edinburgh Depression Scale were classified as currently depressed. Crude (cOR) and adjusted (aOR) odds ratios and 95% confidence intervals [CI] were computed from univariate and multivariable logistic models, with weighting for study design and differential consent. Marginal structural models examined potential selection bias due to low follow-up.

Results: Current depression was more likely in women with stillbirth (14.8%) vs. healthy livebirth (8.3%, cOR 1.90 [95% CI 1.20, 3.02]). However, after control for history of depression and factors associated with both depression and stillbirth, the stillbirth association was no longer significant (aOR 1.35 [95% CI 0.79, 2.30]). Conversely, for the 76% of women with no history of depression, a significant association remained after adjustment for confounders (aOR 1.98 [95% CI 1.02, 3.82]).

Conclusions: Improved screening for depression and referral may be needed for women's health care. Research should focus on defining optimal methods for support of women suffering stillbirth so as to lower the risk of subsequent depression.
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http://dx.doi.org/10.1111/ppe.12176DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4371866PMC
March 2015

Prediction of abnormal postpartum glucose tolerance testing in mild gestational diabetes mellitus.

J Reprod Med 2014 Jul-Aug;59(7-8):393-400

Objective: To describe the liikelihood of women with gestational diabetes mellitus (GDM)--who are at increased risk for developing overt diabetes--undergoing postpartum testing, and the patient characteristics associated with abnormal postpartum glucose tolerance testing (GTT) in mild GDM.

Study Design: This was a retrospective chart review that included mild GDM patients, defined as those with fasting plasma glucose levels < 95 mg/dL on a 3-hour 100-g oral glucose tolerance test (OGTT). Patients who underwent postpartum testing were assessed and predictive factors for abnormal results evaluated.

Results: Mild GDM was diagnosed in 414 (39.6%) women, 201 (48.6%) of whom completed a postpartum 2-hour 75-g OGTT. Abnormal testing was seen in 69 (34.3%), with diabetes in 6 (3%); those with abnormal testing had been diagnosed with GDM at an earlier gestational age, had higher 1-hour 50-g OGTT values, and were also more likely to require pharmacologic therapy. Combining several variables produced a predictive model with positive and negative predictive values of 50% and 84%, respectively.

Conclusion: Antenatal factors (alone or in combination) do not allow for prediction of abnormal postpartum OGTT results in mild GDM patients. Patients with mild GDM are at a slightly decreased postpartum risk of developing diabetes and prediabetes as compared to other patients with GDM.
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September 2014

Diagnosis of gestational diabetes.

Authors:
Donald R Coustan

Scand J Clin Lab Invest Suppl 2014 ;244:27-33; discussion 32-3

Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University , Providence, RI , USA.

Abstract Previous approaches to diagnosing gestational diabetes mellitus (GDM) have included 50 g, 75 g and 100 g glucose challenges, lasting 1-3 hours, with 1 or 2 elevations required. Thresholds were validated by their predictive value for subsequent diabetes, or were the same thresholds used in non-pregnant individuals. None were based on their prediction of adverse pregnancy outcomes. Diagnostic paradigms vary throughout the world, making comparisons impossible and severely limiting communication among investigators. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study collected outcome data on > 23,000 pregnancies recruited prospectively in nine countries after a blinded 75 g, 2-hour oral glucose tolerance test (OGTT) at 24-28 weeks gestation. Primary outcomes (LGA, PCS, neonatal hypoglycemia, high cord C-peptide), and most secondary outcomes (e.g. preeclampsia, preterm birth, shoulder dystocia and birth injury), were significantly, directly and continuously related to each of the three plasma glucose measurements. The International Association of Diabetes in Pregnancy Study Groups (IADPSG) developed recommendations for the use of a 75 g, 2-h OGTT, ≥ 1 elevation diagnosing GDM, with thresholds: fasting plasma glucose ≥ 5.1 mmol/L (92 mg/dL) , 1 h ≥ 10 mmol/L (180 mg/dL) and 2 h ≥ 8.5 mmol/L (153 mg/dL). These have generated wide discussion and are currently being considered throughout the world. They are pregnancy outcome-based; the 75 g glucose load will bring consistency to GTTs; universal adoption will lead to consistency of diagnostic criteria worldwide; studies of treatment at similarly mild levels of glycemia have demonstrated improvement in outcomes; use of a single abnormal value will obviate the confusion arising when one elevated value is encountered. The primary argument against the recommendations is that prevalence of GDM will rise to 16-18 %, increasing health care costs. Balanced against this is the world-wide epidemic of obesity, prediabetes and diabetes.
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http://dx.doi.org/10.3109/00365513.2014.936677DOI Listing
April 2015

Counterpoint: Establishing consensus in the diagnosis of GDM following the HAPO study.

Curr Diab Rep 2014 Jun;14(6):497

University of Queensland, Mater Medical Research Institute Level 3, South Brisbane, Queensland, Australia,

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) recommended a new protocol of 1-step testing with a 75 g oral glucose tolerance test for gestational diabetes in 2010. Since that time, these recommendations have been carefully scrutinized and accepted by a variety of organizations, but challenged or rejected by others. In the current review, we present more details regarding the background to the development of the IADPSG recommendations and seek to place them in context with the available epidemiologic and randomized controlled trial data. In this "counterpoint," we also provide specific rebuttal for errors of fact and disputed contentions provided by Long and Cundy in their 2013 article in Current Diabetes Reports.
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http://dx.doi.org/10.1007/s11892-014-0497-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4039030PMC
June 2014

Fetal growth and risk of stillbirth: a population-based case-control study.

PLoS Med 2014 Apr 22;11(4):e1001633. Epub 2014 Apr 22.

Columbia University Medical Center, New York, New York, United States of America.

Background: Stillbirth is strongly related to impaired fetal growth. However, the relationship between fetal growth and stillbirth is difficult to determine because of uncertainty in the timing of death and confounding characteristics affecting normal fetal growth.

Methods And Findings: We conducted a population-based case-control study of all stillbirths and a representative sample of live births in 59 hospitals in five geographic areas in the US. Fetal growth abnormalities were categorized as small for gestational age (SGA) (<10th percentile) or large for gestational age (LGA) (>90th percentile) at death (stillbirth) or delivery (live birth) using population, ultrasound, and individualized norms. Gestational age at death was determined using an algorithm that considered the time-of-death interval, postmortem examination, and reliability of the gestational age estimate. Data were weighted to account for the sampling design and differential participation rates in various subgroups. Among 527 singleton stillbirths and 1,821 singleton live births studied, stillbirth was associated with SGA based on population, ultrasound, and individualized norms (odds ratio [OR] [95% CI]: 3.0 [2.2 to 4.0]; 4.7 [3.7 to 5.9]; 4.6 [3.6 to 5.9], respectively). LGA was also associated with increased risk of stillbirth using ultrasound and individualized norms (OR [95% CI]: 3.5 [2.4 to 5.0]; 2.3 [1.7 to 3.1], respectively), but not population norms (OR [95% CI]: 0.6 [0.4 to 1.0]). The associations were stronger with more severe SGA and LGA (<5th and >95th percentile). Analyses adjusted for stillbirth risk factors, subset analyses excluding potential confounders, and analyses in preterm and term pregnancies showed similar patterns of association. In this study 70% of cases and 63% of controls agreed to participate. Analysis weights accounted for differences between consenting and non-consenting women. Some of the characteristics used for individualized fetal growth estimates were missing and were replaced with reference values. However, a sensitivity analysis using individualized norms based on the subset of stillbirths and live births with non-missing variables showed similar findings.

Conclusions: Stillbirth is associated with both growth restriction and excessive fetal growth. These findings suggest that, contrary to current practices and recommendations, stillbirth prevention strategies should focus on both severe SGA and severe LGA pregnancies. Please see later in the article for the Editors' Summary.
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http://dx.doi.org/10.1371/journal.pmed.1001633DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3995658PMC
April 2014

Response to: improving postpartum screening rates.

Arch Gynecol Obstet 2014 Jun;289(6):1161

Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, 6431 Fannin MSB 3.286, Houston, TX, 77030, USA,

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http://dx.doi.org/10.1007/s00404-014-3214-8DOI Listing
June 2014

Impact of an intensive follow-up program on the postpartum glucose tolerance testing rate.

Arch Gynecol Obstet 2014 Jun 31;289(6):1177-83. Epub 2014 Jan 31.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, UT Health Science Center at Houston, 6431 Fannin MSB 3.286, Houston, TX, 77030, USA,

Objective: Gestational diabetes mellitus (GDM) is a strong risk factor for the development of diabetes. We assessed the impact of a 1-year intensive follow-up demonstration program, using direct nurse and outreach worker case management, aimed at increasing compliance with postpartum oral glucose tolerance testing (OGTT).

Study Design: During the year of implementation, a nurse or bilingual outreach worker contacted patients to encourage attendance at their scheduled postpartum 2-h 75-g OGTT and assisted in overcoming obstacles to testing. All patients with GDM seen in our specialty clinic the previous year served as a control group for comparison.

Results: One hundred eighty-one patients treated during the year prior to implementation were compared to the 207 in the demonstration program. Baseline characteristics were similar in both groups. After the program's implementation, postpartum OGTT adherence increased from 43.1 to 59.4 % (p < 0.01, hazard ratio 1.59; 95 % confidence interval 1.20-2.12). Had the program been in place the previous year, we calculated that 12 additional cases of diabetes or prediabetes would have been detected, increasing the total number from 33 to 45 such cases.

Conclusion: Implementation of direct nurse and outreach worker case management leads to a modest, but important increase in adherence to postpartum OGTT testing.
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http://dx.doi.org/10.1007/s00404-014-3157-0DOI Listing
June 2014

Association between stillbirth and illicit drug use and smoking during pregnancy.

Obstet Gynecol 2014 Jan;123(1):113-125

For a list of other members of the Stillbirth Collaborative Research Network, see the Appendix online at http://links.lww.com/AOG/A455. University of Utah School of Medicine, Salt Lake City, Utah; Rollins School of Public Health, Emory University, and Emory University School of Medicine, Atlanta, Georgia; the Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; RTI International, Research Triangle Park, North Carolina; Columbia University, New York, New York; the University of Texas Medical Branch at Galveston, Galveston, and the University of Texas Health Science Center at San Antonio, San Antonio, Texas; and Brown University School of Medicine, Providence, Rhode Island.

Objective: To compare illicit drug and smoking use in pregnancies with and without stillbirth.

Methods: The Stillbirth Collaborative Research Network conducted a case-control study from March 2006 to September 2008, covering more than 90% of deliveries to residents of five a priori-defined geographically diverse regions. The study attempted to include all stillbirths and representative liveborn controls. Umbilical cord samples from cases and controls were collected and frozen for subsequent batch analysis. Maternal serum was collected at delivery and batch analyzed for cotinine.

Results: For 663 stillbirth deliveries, 418 (63%) had cord homogenate and 579 (87%) had maternal cotinine assays performed. For 1,932 live birth deliveries, 1,050 (54%) had cord homogenate toxicology and 1,545 (80%) had maternal cotinine assays performed. A positive cord homogenate test for any illicit drug was associated with stillbirth (odds ratio [OR] 1.94, 95% confidence interval [CI] 1.16-3.27). The most common individual drug was cannabis (OR 2.34 95% CI 1.13-4.81), although the effect was partially confounded by smoking. Both maternal self-reported smoking history and maternal serum cotinine levels were associated in a dose-response relationship with stillbirth. Positive serum cotinine less than 3 ng/mL and no reported history of smoking (proxy for passive smoke exposure) also were associated with stillbirth (OR 2.06, 95% CI 1.24-3.41).

Conclusion: Cannabis use, smoking, illicit drug use, and apparent exposure to second-hand smoke, separately or in combination, during pregnancy were associated with an increased risk of stillbirth. Because cannabis use may be increasing with increased legalization, the relevance of these findings may increase as well.

Level Of Evidence: II.
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http://dx.doi.org/10.1097/AOG.0000000000000052DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3931517PMC
January 2014

Placental findings in singleton stillbirths.

Obstet Gynecol 2014 Feb;123(2 Pt 1):325-336

The Warren Alpert Medical School of Brown University, Providence, Rhode Island; Columbia University School of Medicine, New York, New York; RTI International, Durham, North Carolina; the University of Texas Health Science Center at San Antonio, San Antonio, and the University of Texas Medical Branch, Galveston, Texas; Emory University, Atlanta, Georgia; the University of Utah School of Medicine, Salt Lake City, Utah; Tufts University Medical Center, Boston, Masachusetts; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. For a list of members in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Stillbirth Collaborative Research Network, see the Appendix online at http://links.lww.com/AOG/A465.

Objective: To compare placental lesions for stillbirth cases and live birth controls in a population-based study.

Methods: Pathologic examinations were performed on placentas from singleton pregnancies using a standard protocol. Data were analyzed overall and within gestational age groups at delivery.

Results: Placentas from 518 stillbirths and 1,200 live births were studied. Single umbilical artery was present in 7.7% of stillbirths and 1.7% of live births, velamentous cord insertion was present in 5% of stillbirths and 1.1% of live births, diffuse terminal villous immaturity was present in 10.3% of stillbirths and 2.3% of live births, inflammation (eg, acute chorioamnionitis of placental membranes) was present in 30.4% of stillbirths and 12% of live births, vascular degenerative changes in chorionic plate were present in 55.7% of stillbirths and 0.5% of live births, retroplacental hematoma was present in 23.8% of stillbirths and 4.2% of live births, intraparenchymal thrombi was present in 19.7% of stillbirths and 13.3% of live births, parenchymal infarction was present in 10.9% of stillbirths and 4.4% of live births, fibrin deposition was present in 9.2% of stillbirths and 1.5% of live births, fetal vascular thrombi was present in 23% of stillbirths and 7% of live births, avascular villi was present in 7.6% of stillbirths and 2.0% of live births, and hydrops was present in 6.4% of stillbirths and 1.0% of live births. Among stillbirths, inflammation and retroplacental hematoma were more common in placentas from early deliveries, whereas thrombotic lesions were more common in later gestation. Inflammatory lesions were especially common in early live births.

Conclusions: Placental lesions were highly associated with stillbirth compared with live births. All lesions associated with stillbirth were found in live births but often with variations by gestational age at delivery. Knowledge of lesion prevalence within gestational age groups in both stillbirths and live birth controls contributes to an understanding of the association between placental abnormality and stillbirth.

Level Of Evidence: II.
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http://dx.doi.org/10.1097/AOG.0000000000000100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3948332PMC
February 2014

Treating mild gestational diabetes yields benefits with little or no evidence of harms.

Authors:
Donald Coustan

Evid Based Med 2014 Jun 26;19(3):88. Epub 2013 Nov 26.

Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island, Providence, Rhode Island, USA.

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http://dx.doi.org/10.1136/eb-2013-101520DOI Listing
June 2014

Can hemoglobin A1c in early pregnancy predict adverse pregnancy outcomes in diabetic patients?

J Diabetes Complications 2014 Mar-Apr;28(2):203-7. Epub 2013 Oct 23.

Obstetrics and Gynecology, Division of MFM, Women & Infants Hospital of RI, Providence, RI 02905; The Warren Alpert Medical School of Brown University, Providence, RI 02806.

Objective: To examine the association of elevated early pregnancy hemoglobin A1c (HbA1c) levels with adverse pregnancy outcomes in women with preexisting diabetes mellitus.

Study Design: Retrospective cohort study of 330 women with preexisting diabetes enrolled in a Diabetes in Pregnancy Program at an academic institution between 2003 and 2011 who had an early HbA1c determination. The frequencies of composite maternal adverse pregnancy outcomes (birth at<37 weeks, preeclampsia, and medically indicated birth <39 weeks), and composite fetal adverse pregnancy outcomes [shoulder dystocia, Apgar scores<7 at 5 minutes, small for gestational age (SGA), large for gestational age (LGA), and stillbirth] were compared between HbA1c categories (<6.5, 6.5-7.4, 7.5-8.4 and ≥ 8.5%).

Results: There was no statistically significant difference between composite adverse maternal pregnancy outcomes and composite adverse fetal pregnancy outcomes as well as other individual outcomes between different HbA1c categories. Of the vaginally delivered women in our cohort, the 37 patients with HbA1c levels of ≥ 8.5% had a significantly higher frequency of fetal shoulder dystocia than the 62 with HbA1c levels of < 8.5% (24.2 vs. 1.6%, P = 0.002). Neonates of patients with HbA1c ≥ 8.5% were more likely to have low five minute Apgar scores than neonates of patients with HbA1c < 8.5%, but this was of borderline statistical significance (7.4% vs. 0.5%, P = 0.05).

Conclusion: In patients with preexisting diabetes mellitus, HbA1c levels of ≥ 8.5% during early pregnancy are not useful in predicting most adverse outcomes, although there may be an increased risk for shoulder dystocia.
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http://dx.doi.org/10.1016/j.jdiacomp.2013.10.004DOI Listing
November 2014

Bile acids in a multicenter, population-based case-control study of stillbirth.

Am J Obstet Gynecol 2014 May 8;210(5):460.e1-9. Epub 2013 Nov 8.

Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.

Objective: We sought to compare bile acids in women with and without stillbirth in a population-based study.

Study Design: The Stillbirth Collaborative Research Network conducted a multisite, population-based case-control study of stillbirth (fetal deaths ≥20 weeks). Maternal sera were obtained at the time of enrollment and frozen at -80°C until assay for bile acids.

Results: Assays were performed in 581 women with stillbirth and 1546 women with live births. Bile acid levels were slightly higher in women with stillbirth (geometric mean [95% confidence interval {CI}] = 3.2 [3.0-3.5]) compared to live births (2.9 [2.7-3.1], P = .0327). However, the difference was not significant after adjustment for baseline risk factors for stillbirth. The proportion of women with elevated levels (≥10 or ≥40 μmol/L) was similar in stillbirths and live births. Results were similar when the analysis was limited to subsets of stillbirths and live births. In women with stillbirths not associated with fetal anomalies or obstetric complications bile acid levels were higher than in women with term live births (geometric mean [95% CI] = 3.4 [3.0-3.8] vs 2.9 [2.7-3.0], P = .0152, unadjusted; P = .06, adjusted). However, a similar proportion of women in both groups had levels ≥10 μmol/L (10.7 vs 7.2%; odds ratio [OR], 1.54; 95% CI, 0.97-2.44; adjusted OR, 1.29; 95% CI, 0.78-2.15) and ≥40 μmol/L (1.7 vs 0.7%; OR, 2.58; 95% CI, 0.85-7.84; adjusted OR, 2.28; 95% CI, 0.79-6.56).

Conclusion: Our data do not support testing for bile acids in cases of stillbirth in the absence of clinical evidence of intrahepatic cholestasis of pregnancy.
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http://dx.doi.org/10.1016/j.ajog.2013.11.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413928PMC
May 2014