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Publication Record


Association between First Trimester Antidepressant Use and Risk of Spontaneous Abortion.
Wu P, Velez Edwards DR, Gorrindo P, Sundermann AC, Torstenson ES, Jones SH, Chan RL, Hartmann KE
(2019) Pharmacotherapy 39: 889-898
MeSH Terms: Abortion, Spontaneous, Adult, Antidepressive Agents, Female, Humans, Pregnancy, Pregnancy Trimester, First, Proportional Hazards Models, Prospective Studies, Serotonin Uptake Inhibitors, United States, Young Adult
Show Abstract · Added August 5, 2020
STUDY OBJECTIVE - The potential for maternal antidepressant use to influence the risk of spontaneous abortion, one of the most important adverse pregnancy outcomes, is not clear. We aimed to assess whether first trimester antidepressant exposure was associated with an increased risk of spontaneous abortion.
DESIGN - Community-based prospective cohort study (Right from the Start).
SETTING - Eight metropolitan areas in North Carolina, Tennessee, and Texas.
PARTICIPANTS - A total of 5451 women (18 years of age or older) who were planning to conceive or were pregnant (before 12 weeks of completed gestation) and were enrolled in the study between 2000 and 2012; of those women, 223 used antidepressants (selective serotonin reuptake inhibitors [SSRIs] only [170], SSRIs and non-SSRIs [9], and non-SSRIs only [44]) during their first trimester, and 5228 did not (never users). Measurements and Main Results First trimester antidepressant use was determined during a first trimester telephone interview. Spontaneous abortion was self-reported and verified by medical records. The association of first trimester antidepressant use and spontaneous abortion was assessed by using Cox proportional hazard regression. Among the 5451 women enrolled, 223 (4%) reported first trimester antidepressant use, and 659 (12%) experienced a spontaneous abortion. SSRIs were the most common class of antidepressants used (179 [80%]). Compared with women who never used antidepressants during the first trimester of pregnancy, women who reported antidepressant use were 34% (adjusted hazard ratio [aHR] 1.34, 95% confidence interval [CI] 0.97-1.85) more likely to experience a spontaneous abortion after adjusting for covariates. Women who reported ever using SSRIs were 45% (aHR 1.45, 95% CI 1.02-2.06) more likely to experience a spontaneous abortion compared with never users. When time of loss relative to the time of interview was taken into consideration, the association between first trimester SSRI use and spontaneous abortion was significant only among those with losses before the interview (aHR 1.49, 95% CI 1.04-2.13) but was not significant among those with losses after the interview (aHR 0.43, 95% CI 0.06-3.15).
CONCLUSION - The association between use of first trimester antidepressants, particularly SSRI use, and spontaneous abortion was significant only among women whose exposure status was assessed after loss. In this instance, reporting bias may create a spurious association. Future studies should take the timing of data collection relative to the timing of loss into consideration.
© 2019 Pharmacotherapy Publications, Inc.
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In vivo Raman spectroscopy for biochemical monitoring of the human cervix throughout pregnancy.
O'Brien CM, Vargis E, Rudin A, Slaughter JC, Thomas G, Newton JM, Reese J, Bennett KA, Mahadevan-Jansen A
(2018) Am J Obstet Gynecol 218: 528.e1-528.e18
MeSH Terms: Adult, Cervix Uteri, Female, Healthy Volunteers, Humans, Parturition, Postpartum Period, Pregnancy, Pregnancy Trimester, First, Pregnancy Trimester, Second, Pregnancy Trimester, Third, Spectrum Analysis, Raman
Show Abstract · Added March 31, 2018
BACKGROUND - The cervix must undergo significant biochemical remodeling to allow for successful parturition. This process is not fully understood, especially in instances of spontaneous preterm birth. In vivo Raman spectroscopy is an optical technique that can be used to investigate the biochemical composition of tissue longitudinally and noninvasively in human beings, and has been utilized to measure physiology and disease states in a variety of medical applications.
OBJECTIVE - The purpose of this study is to measure in vivo Raman spectra of the cervix throughout pregnancy in women, and to identify biochemical markers that change with the preparation for delivery and postpartum repair.
STUDY DESIGN - In all, 68 healthy pregnant women were recruited. Raman spectra were measured from the cervix of each patient monthly in the first and second trimesters, weekly in the third trimester, and at the 6-week postpartum visit. Raman spectra were measured using an in vivo Raman system with an optical fiber probe to excite the tissue with 785 nm light. A spectral model was developed to highlight spectral regions that undergo the most changes throughout pregnancy, which were subsequently used for identifying Raman peaks for further analysis. These peaks were analyzed longitudinally to determine if they underwent significant changes over the course of pregnancy (P < .05). Finally, 6 individual components that comprise key biochemical constituents of the human cervix were measured to extract their contributions in spectral changes throughout pregnancy using a linear combination method. Patient factors including body mass index and parity were included as variables in these analyses.
RESULTS - Raman peaks indicative of extracellular matrix proteins (1248 and 1254 cm) significantly decreased (P < .05), while peaks corresponding to blood (1233 and 1563 cm) significantly increased (P < .0005) in a linear manner throughout pregnancy. In the postpartum cervix, significant increases in peaks corresponding to actin (1003, 1339, and 1657 cm) and cholesterol (1447 cm) were observed when compared to late gestation, while signatures from blood significantly decreased. Postpartum actin signals were significantly higher than early pregnancy, whereas extracellular matrix proteins and water signals were significantly lower than early weeks of gestation. Parity had a significant effect on blood and extracellular matrix protein signals, with nulliparous patients having significant increases in blood signals throughout pregnancy, and higher extracellular matrix protein signals in early pregnancy compared to patients with prior pregnancies. Body mass index significantly affected actin signal contribution, with low body mass index patients showing decreasing actin contribution throughout pregnancy and high body mass index patients demonstrating increasing actin signals.
CONCLUSION - Raman spectroscopy was successfully used to biochemically monitor cervical remodeling in pregnant women during prenatal visits. This foundational study has demonstrated sensitivity to known biochemical dynamics that occur during cervical remodeling, and identified patient variables that have significant effects on Raman spectra throughout pregnancy. Raman spectroscopy has the potential to improve our understanding of cervical maturation, and be used as a noninvasive preterm birth risk assessment tool to reduce the incidence, morbidity, and mortality caused by preterm birth.
Copyright © 2018. Published by Elsevier Inc.
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Prospective Cohort Study of Uterine Fibroids and Miscarriage Risk.
Hartmann KE, Velez Edwards DR, Savitz DA, Jonsson-Funk ML, Wu P, Sundermann AC, Baird DD
(2017) Am J Epidemiol 186: 1140-1148
MeSH Terms: Abortion, Spontaneous, Adult, Comorbidity, Confidence Intervals, Confounding Factors, Epidemiologic, Female, Humans, Interviews as Topic, Leiomyoma, Medical History Taking, North Carolina, Pregnancy, Pregnancy Trimester, First, Proportional Hazards Models, Prospective Studies, Reproductive History, Tennessee, Texas, Ultrasonography, Young Adult
Show Abstract · Added February 21, 2019
We sought to determine the relationship of fibroids to pregnancy loss in a prospective cohort in which fibroid status was uniformly documented in early pregnancy. Participants had an intake interview, transvaginal ultrasonography, computer-assisted telephone interview, and follow-up assessment of outcomes. We recruited diverse participants for the Right From the Start study from 8 metropolitan areas in 3 states in the United States during 2000-2012. Participants were at least 18 years of age, trying to become pregnant or at less than 12 weeks' gestation, not using fertility treatments, fluent in English or Spanish, and available for telephone interviews. Miscarriage was defined as loss before 20 weeks' gestation. Fibroid presence, number, type, and volume were assessed using standardized ultrasonography methods. We used proportional hazards models to estimate associations. Among 5,512 participants, 10.4% had at least 1 fibroid, and 10.8% experienced a miscarriage. Twenty-three percent had experienced a prior miscarriage and 52% prior births. Presence of fibroids was associated with miscarriage in models without adjustments. Adjusting for key confounders indicated no increase in risk (adjusted hazard ratio = 0.83, 95% confidence interval: 0.63, 1.08). No characteristic of fibroids was associated with risk. Prior evidence attributing miscarriage to fibroids is potentially biased. These findings imply that surgical removal of fibroids to reduce risk of miscarriage deserves careful scrutiny.
© The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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20 MeSH Terms
Pregnancy Intention and Maternal Alcohol Consumption.
Pryor J, Patrick SW, Sundermann AC, Wu P, Hartmann KE
(2017) Obstet Gynecol 129: 727-733
MeSH Terms: Adult, Alcohol Drinking, Cohort Studies, Female, Health Promotion, Humans, Intention, Pregnancy, Pregnancy Trimester, First, Pregnancy, Unplanned, Preventive Health Services, Reproductive Behavior, Reproductive Health Services, Risk Reduction Behavior, Tennessee
Show Abstract · Added February 21, 2019
OBJECTIVE - To evaluate whether women planning a pregnancy are less likely to use alcohol in early pregnancy than those with unintended pregnancies.
METHODS - Right From the Start (2000-2012) is a prospective, community-based pregnancy cohort. Maternal demographic, reproductive, and behavioral data were collected in telephone interviews at enrollment (mean±standard deviation 48±13 days of gestation) and later in the first trimester (mean±standard deviation 85±21 days of gestation). Alcohol consumption characteristics were included in the interviews. We used logistic regression to investigate the association of pregnancy intention with alcohol use.
RESULTS - Among 5,036 women, 55% reported using alcohol in the first trimester with 6% continuing use at the first-trimester interview. Pregnancy was planned by 70% of participants. Alcohol use occurred in 55% and 56% of intended and unintended pregnancies, respectively (P=.32). Adjusting for confounders, women with intended pregnancies were 31% less likely to consume any alcohol in early pregnancy (adjusted odds ratio [OR] 0.69, 95% confidence interval [CI] 0.60-0.81) or binge drink (adjusted OR 0.68, 95% CI 0.54-0.86). Most women, regardless of intention, stopped or decreased alcohol consumption in early pregnancy.
CONCLUSION - The majority of women, irrespective of intention, stopped or decreased drinking after pregnancy recognition. This suggests promoting early pregnancy awareness could prove more effective than promoting abstinence from alcohol among all who could conceive.
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Validation of maternal recall of early pregnancy medication exposure using prospective diary data.
Sundermann AC, Hartmann KE, Jones SH, Torstenson ES, Velez Edwards DR
(2017) Ann Epidemiol 27: 135-139.e2
MeSH Terms: Adolescent, Adult, Anti-Inflammatory Agents, Non-Steroidal, Data Collection, Female, Humans, Interviews as Topic, Maternal Exposure, Mental Recall, Middle Aged, Nonprescription Drugs, North Carolina, Pregnancy, Pregnancy Complications, Pregnancy Trimester, First, Prescription Drugs, Prospective Studies, Sensitivity and Specificity, Tennessee, Texas, Young Adult
Show Abstract · Added February 21, 2019
PURPOSE - Data about maternal recall accuracy for classifying early pregnancy medication exposure are meager. Nonetheless, studies often rely on recall to evaluate potential impact of pharmaceuticals on the developing fetus.
METHODS - Right from the Start is a community-based pregnancy cohort that enrolled women from North Carolina, Tennessee, and Texas. A subset of 318 women participated in daily medication diaries initiated before conception (2006-2012). We examined nonsteroidal anti-inflammatory drugs (NSAIDs) as an example of a drug type that is difficult to study due to its intermittent and primarily over-the-counter use as well as its incomplete documentation in medical and pharmaceutical records. Selective serotonin reuptake inhibitors (SSRI) were assessed as a prescription medication comparator. Maternal recall of NSAID and SSRI use in early pregnancy was examined by comparing diary data (gold standard) to first-trimester interview.
RESULTS - Sensitivity and specificity for recall of NSAID exposure were 78.6% and 62.3%, respectively (kappa statistic: 0.41), with 72.3% agreement for exposure classification. Sensitivity and specificity for recall of SSRI exposure were 77.8% and 99.0%, respectively (kappa statistic: 0.79), with 97.8% agreement.
CONCLUSIONS - Our findings suggest the validity of maternal recall varies with medication type and prospective data collection should be prioritized when studying early pregnancy drug exposures.
Copyright © 2016 Elsevier Inc. All rights reserved.
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The Relationship between Total Fibroid Burden and First Trimester Bleeding and Pain.
Michels KA, Hartmann KE, Archer KR, Ye F, Edwards DR
(2016) Paediatr Perinat Epidemiol 30: 115-23
MeSH Terms: Adolescent, Adult, African Americans, European Continental Ancestry Group, Female, Humans, Pain, Pregnancy, Pregnancy Complications, Cardiovascular, Pregnancy Complications, Neoplastic, Pregnancy Trimester, First, Prospective Studies, United States, Uterine Hemorrhage, Uterine Neoplasms, Young Adult
Show Abstract · Added February 22, 2016
BACKGROUND - Few studies comment on the association between fibroids and symptoms among pregnant women. These studies generally are retrospective and do not to assess the influence of number of tumours or their volume on risk of symptoms.
METHODS - Right from the Start is a prospective cohort that enrolled pregnant women from the southeastern USA between 2000 and 2012. In the first trimester, all participants had standardised ultrasounds to determine the presence or absence of fibroids. Symptoms were queried in a telephone survey. We used polytomous logistic regression to model odds of bleeding, pain, or both symptoms in relation to increasing total fibroid number and volume among white and black women.
RESULTS - Among 4509 participants, the prevalence of fibroids was 11%. Among those reporting symptoms (70%), 11% reported only bleeding, 59% reported only pain, and 30% reported both symptoms. After adjusting for age, race, parity, hypertension, smoking, alcohol use, and study site, increasing number of fibroids was associated with pain [odds ratio (OR) 1.16, 95% confidence interval (CI) 1.00, 1.33] and both symptoms [OR 1.25, 95% CI 1.08, 1.45] but not with bleeding among all women. Fibroid volume was not associated with symptoms among black women, but white women with the smallest fibroid volumes were more likely to report both symptoms than those without fibroids [OR 1.79, 95% CI 1.17, 2.72].
CONCLUSIONS - Very large tumours are not requisite for experiencing symptoms, as small fibroids and increasing number of tumours are associated with pain and both symptoms.
© 2015 John Wiley & Sons Ltd.
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16 MeSH Terms
First-trimester antihistamine exposure and risk of spontaneous abortion or preterm birth.
Aldridge TD, Hartmann KE, Michels KA, Velez Edwards DR
(2014) Pharmacoepidemiol Drug Saf 23: 1043-50
MeSH Terms: Abortion, Spontaneous, Adolescent, Adult, Female, Histamine Antagonists, Humans, Maternal Exposure, Pregnancy, Pregnancy Trimester, First, Prospective Studies, Risk, United States, Young Adult
Show Abstract · Added June 27, 2014
PURPOSE - We tested whether antihistamine exposure during early pregnancy is associated with spontaneous abortion (SAB) or preterm birth (PTB).
METHODS - Women were enrolled in Right from the Start (2004-2010), a prospective pregnancy cohort. Data about first-trimester antihistamine use were obtained from screening and first-trimester interviews. Self-reported outcomes included SAB and PTB and were verified by medical records. Cox proportional hazards models were used to test for an association between antihistamine use and each outcome, both performed adjusting for confounders.
RESULTS - Among the 2685 pregnancies analyzed, 14% (n = 377) reported use of antihistamines. Among antihistamine users, 12% (n = 44) experienced SABs, and 6% (n = 21) had PTBs. Antihistamine exposure was not associated with SAB (adjusted hazard ratio [aHR] = 0.88, 95% confidence interval [CI] 0.64, 1.21) or PTB, which was modified by maternal race (aHR = 1.03, 95%CI 0.61, 1.72 among White women and aHR = 0.43, 95%CI 0.14, 1.34 among Black women).
CONCLUSIONS - Despite the biologic plausibility that antihistamine use may influence pregnancy outcomes, we did not detect evidence of an association with SAB or PTB. These data demonstrate the utility of large prospective cohorts for evaluating drug safety in pregnancy when concerns are raised from animal models.
Copyright © 2014 John Wiley & Sons, Ltd.
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13 MeSH Terms
Association of folic acid supplementation during pregnancy and infant bronchiolitis.
Veeranki SP, Gebretsadik T, Dorris SL, Mitchel EF, Hartert TV, Cooper WO, Tylavsky FA, Dupont W, Hartman TJ, Carroll KN
(2014) Am J Epidemiol 179: 938-46
MeSH Terms: Adolescent, Adult, Bronchiolitis, Viral, Cohort Studies, Dietary Supplements, Female, Folic Acid, Humans, Infant, Logistic Models, Male, Neural Tube Defects, Odds Ratio, Pregnancy, Pregnancy Trimester, First, Prenatal Care, Prenatal Exposure Delayed Effects, Retrospective Studies, Severity of Illness Index, Vitamin B Complex, Young Adult
Show Abstract · Added May 27, 2014
Viral bronchiolitis affects 20%-30% of infants; because there is no known effective treatment, it is important to identify risk factors that contribute to its pathogenesis. Although adequate folate intake during the periconceptional period prevents neural tube defects, animal data suggest that higher supplementation may be a risk factor for child respiratory diseases. Using a population-based retrospective cohort of 167,333 women and infants, born in 1995-2007 and enrolled in the Tennessee Medicaid program, we investigated the association between the filling of folic acid-containing prescriptions and infant bronchiolitis. We categorized women into the following 4 groups in relation to the first trimester: "none" (no prescription filled), "first trimester only," "after first trimester," and "both" (prescriptions filled both during and after the first trimester). Overall, 21% of infants had a bronchiolitis diagnosis, and 5% were hospitalized. Most women filled their first prescriptions after the fifth to sixth weeks of pregnancy, and most prescriptions contained 1,000 µg of folic acid. Compared with infants born to women in the "none" group, infants born to women in the "first trimester only" group had higher relative odds of bronchiolitis diagnosis (adjusted odds ratio = 1.17, 95% confidence interval: 1.11, 1.22) and greater severity (adjusted odds ratio = 1.16, 95% confidence interval: 1.11, 1.22). This study's findings contribute to an understanding of the implications of prenatal nutritional supplement recommendations for infant bronchiolitis.
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21 MeSH Terms
Racial differences in risk of spontaneous abortions associated with periconceptional over-the-counter nonsteroidal anti-inflammatory drug exposure.
Velez Edwards DR, Hartmann KE
(2014) Ann Epidemiol 24: 111-115.e1
MeSH Terms: Abortion, Spontaneous, Adult, African Americans, Anti-Inflammatory Agents, Non-Steroidal, European Continental Ancestry Group, Female, Gestational Age, Healthcare Disparities, Humans, Incidence, Interviews as Topic, Nonprescription Drugs, Pregnancy, Pregnancy Outcome, Pregnancy Trimester, First, Prevalence, Proportional Hazards Models, Prospective Studies, Regression Analysis, Risk Factors, Socioeconomic Factors, United States, Young Adult
Show Abstract · Added March 5, 2014
PURPOSE - Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most common medications reported in pregnancy. NSAIDs directly impact prostaglandin pathways and have been proposed as potential risk factors for spontaneous abortions (SABs, gestation <20 weeks). SAB risk and drug response across several medications differ by race; therefore, we evaluated whether associations between NSAIDs and SAB risk differ by race.
METHODS - Women were enrolled in the Right from the Start (2004-2010) prospective cohort. Data regarding over-the-counter NSAIDs up to the sixth week of pregnancy were obtained from interviews. Race was self-reported. Cox proportional hazards regression models were used to estimate the association between NSAID exposure and SAB, adjusted for confounders.
RESULTS - Among 2493 pregnancies, 12% were African American and 88% were Caucasian. NSAID exposure was reported by 40% (n = 124) of African Americans and 43% (n = 945) of Caucasians. Race-stratified analyses showed protection from SAB among African Americans (adjusted hazard ratio [aHR], 0.84; 95% confidence interval [CI], 0.73-0.96) but no effect in Caucasians (aHR, 1.01; 95% CI 0.88-1.16).
CONCLUSIONS - Our findings suggest that risk for SAB due to over-the-counter NSAIDs in early pregnancy is modified by race. Further investigation of dose, timing in gestation, and indication may help to further reconcile the relationship between race, NSAIDs, and SAB.
Copyright © 2014 Elsevier Inc. All rights reserved.
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23 MeSH Terms
Periconceptional over-the-counter nonsteroidal anti-inflammatory drug exposure and risk for spontaneous abortion.
Edwards DR, Aldridge T, Baird DD, Funk MJ, Savitz DA, Hartmann KE
(2012) Obstet Gynecol 120: 113-22
MeSH Terms: Abortion, Spontaneous, Adult, Anti-Inflammatory Agents, Non-Steroidal, Female, Gestational Age, Humans, Nonprescription Drugs, Pregnancy, Pregnancy Outcome, Pregnancy Trimester, First, Proportional Hazards Models, Prospective Studies, Risk, Ultrasonography, Prenatal
Show Abstract · Added March 5, 2014
OBJECTIVE - To estimate the association between over-the-counter nonsteroidal anti-inflammatory drug (NSAID) exposure during the early first trimester and risk for spontaneous abortion (gestation before 20 weeks of gestation) in a prospective cohort.
METHODS - Women were enrolled in the Right from the Start study (2004-2010). Exposure data regarding over-the-counter NSAID use from the last menstrual period (LMP) through the sixth week of pregnancy were obtained from intake and first-trimester interviews. Pregnancy outcomes were self-reported and verified by medical records. Gestational age was determined from the LMP. Stage of development before loss was determined from study ultrasonography. Cox proportional hazards regression models were used to estimate the association between NSAID exposure and pregnancy outcome taking into account candidate confounders.
RESULTS - Among 2,780 pregnancies, 367 women (13%) experienced a spontaneous abortion. NSAID exposure was reported by 1,185 (43%) women. NSAID exposure was not associated with spontaneous abortion risk in unadjusted models (hazard ratio [HR] 1.01, 95% confidence interval [CI] 0.82-1.24) or models adjusted for maternal age (adjusted HR 1.00, 95% CI 0.81-1.23).
CONCLUSION - Our findings suggest that use of nonprescription over-the-counter NSAIDs in early pregnancy does not put women at increased risk of spontaneous abortion.
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14 MeSH Terms