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1.  Are pregnancy planning and pregnancy timing associated with maternal psychiatric illness, psychological distress and support during pregnancy? 
Background
Pregnancy planning and timing may be associated with psychiatric illness, psychological distress and support during pregnancy.
Methods
We performed secondary analyses of a prospective cohort of 2,654 pregnant women evaluating the impact of depression on preterm birth. We used multivariable logistic regression to test associations between pregnancy planning (“Was this pregnancy planned? Yes/No”) and/or timing (“Do you think this is a good time for you to be pregnant?”) with Composite International Diagnostic Interview generated psychiatric diagnoses and measures of psychological distress and support.
Results
37% and 13% of participants reported an unplanned or poorly timed pregnancy, respectively. Unplanned pregnancies were associated with a Major Depressive Episode (MDE) (adjusted odds ratio (aOR) 1.69, 95%CI 1.23–2.32) and the Cohen Perceived Stress Scale’s (CPSS) highest quartile (aOR 1.74, 95%CI 1.40–2.16). Poorly timed pregnancies were associated with a MDE (aOR 3.47, 95%CI 2.46–4.91) and the CPSS’s highest quartile (aOR 5.20, 95%CI 3.93–6.87). Poorly timed pregnancies were also associated with General Anxiety Disorder (GAD; aOR 1.60, 95%CI 1.07–2.40), and the modified Kendler Social Support Inventory’s (MKSSI) lowest quartile (aOR 1.64, 95%CI 1.25–2.16). Psychiatric conditions were strongly associated with planned pregnancies that were subsequently deemed poorly timed (MDE=aOR 5.08, 95%CI 2.52–10.25; GAD=aOR 2.28, 95%CI 1.04–5.03); high CPSS=aOR 6.48, 95%CI 3.59–11.69; and low MKSSI=aOR 3.19, 95%CI 1.81–5.62).
Limitations
Participant characteristics may limit generalizability of findings.
Conclusions
Pregnancy timing was a stronger predictor of maternal psychiatric illness, psychological distress and low social support than pregnancy planning in our cohort.
doi:10.1016/j.jad.2016.06.058
PMCID: PMC5048515  PMID: 27423065
unplanned pregnancy; psychological distress; depression; anxiety; social support
2.  Proceedings of the 14th annual conference of INEBRIA 
Holloway, Aisha S. | Ferguson, Jennifer | Landale, Sarah | Cariola, Laura | Newbury-Birch, Dorothy | Flynn, Amy | Knight, John R. | Sherritt, Lon | Harris, Sion K. | O’Donnell, Amy J. | Kaner, Eileen | Hanratty, Barbara | Loree, Amy M. | Yonkers, Kimberly A. | Ondersma, Steven J. | Gilstead-Hayden, Kate | Martino, Steve | Adam, Angeline | Schwartz, Robert P. | Wu, Li-Tzy | Subramaniam, Geetha | Sharma, Gaurav | McNeely, Jennifer | Berman, Anne H. | Kolaas, Karoline | Petersén, Elisabeth | Bendtsen, Preben | Hedman, Erik | Linderoth, Catharina | Müssener, Ulrika | Sinadinovic, Kristina | Spak, Fredrik | Gremyr, Ida | Thurang, Anna | Mitchell, Ann M. | Finnell, Deborah | Savage, Christine L. | Mahmoud, Khadejah F. | Riordan, Benjamin C. | Conner, Tamlin S. | Flett, Jayde A. M. | Scarf, Damian | McRee, Bonnie | Vendetti, Janice | Gallucci, Karen Steinberg | Robaina, Kate | Clark, Brendan J. | Jones, Jacqueline | Reed, Kathryne D. | Hodapp, Rachel M. | Douglas, Ivor | Burnham, Ellen L. | Aagaard, Laura | Cook, Paul F. | Harris, Brett R. | Yu, Jiang | Wolff, Margaret | Rogers, Meighan | Barbosa, Carolina | Wedehase, Brendan J. | Dunlap, Laura J. | Mitchell, Shannon G. | Dusek, Kristi A. | Gryczynski, Jan | Kirk, Arethusa S. | Oros, Marla T. | Hosler, Colleen | O’Grady, Kevin E. | Brown, Barry S. | Angus, Colin | Sherborne, Sidney | Gillespie, Duncan | Meier, Petra | Brennan, Alan | de Vargas, Divane | Soares, Janaina | Castelblanco, Donna | Doran, Kelly M. | Wittman, Ian | Shelley, Donna | Rotrosen, John | Gelberg, Lillian | Edelman, E. Jennifer | Maisto, Stephen A. | Hansen, Nathan B. | Cutter, Christopher J. | Deng, Yanhong | Dziura, James | Fiellin, Lynn E. | O’Connor, Patrick G. | Bedimo, Roger | Gibert, Cynthia | Marconi, Vincent C. | Rimland, David | Rodriguez-Barradas, Maria C. | Simberkoff, Michael S. | Justice, Amy C. | Bryant, Kendall J. | Fiellin, David A. | Giles, Emma L. | Coulton, Simon | Deluca, Paolo | Drummond, Colin | Howel, Denise | McColl, Elaine | McGovern, Ruth | Scott, Stephanie | Stamp, Elaine | Sumnall, Harry | Vale, Luke | Alabani, Viviana | Atkinson, Amanda | Boniface, Sadie | Frankham, Jo | Gilvarry, Eilish | Hendrie, Nadine | Howe, Nicola | McGeechan, Grant J. | Ramsey, Amy | Stanley, Grant | Clephane, Justine | Gardiner, David | Holmes, John | Martin, Neil | Shevills, Colin | Soutar, Melanie | Chi, Felicia W. | Weisner, Constance | Ross, Thekla B. | Mertens, Jennifer | Sterling, Stacy A. | Shorter, Gillian W. | Heather, Nick | Bray, Jeremy | Cohen, Hildie A. | McPherson, Tracy L. | Adam, Cyrille | López-Pelayo, Hugo | Gual, Antoni | Segura-Garcia, Lidia | Colom, Joan | Ornelas, India J. | Doyle, Suzanne | Donovan, Dennis | Duran, Bonnie | Torres, Vanessa | Gaume, Jacques | Grazioli, Véronique | Fortini, Cristiana | Paroz, Sophie | Bertholet, Nicolas | Daeppen, Jean-Bernard | Satterfield, Jason M. | Gregorich, Steven | Alvarado, Nicholas J. | Muñoz, Ricardo | Kulieva, Gozel | Vijayaraghavan, Maya | Adam, Angéline | Cunningham, John A. | Díaz, Estela | Palacio-Vieira, Jorge | Godinho, Alexandra | Kushir, Vladyslav | O’Brien, Kimberly H. M. | Aguinaldo, Laika D. | Sellers, Christina M. | Spirito, Anthony | Chang, Grace | Blake-Lamb, Tiffany | LaFave, Lea R. Ayers | Thies, Kathleen M. | Pepin, Amy L. | Sprangers, Kara E. | Bradley, Martha | Jorgensen, Shasta | Catano, Nico A. | Murray, Adelaide R. | Schachter, Deborah | Andersen, Ronald M. | Rey, Guillermina Natera | Vahidi, Mani | Rico, Melvin W. | Baumeister, Sebastian E. | Johansson, Magnus | Sinadinovic, Christina | Hermansson, Ulric | Andreasson, Sven | O’Grady, Megan A. | Kapoor, Sandeep | Akkari, Cherine | Bernal, Camila | Pappacena, Kristen | Morley, Jeanne | Auerbach, Mark | Neighbors, Charles J. | Kwon, Nancy | Conigliaro, Joseph | Morgenstern, Jon | Magill, Molly | Apodaca, Timothy R. | Borsari, Brian | Hoadley, Ariel | Scott Tonigan, J. | Moyers, Theresa | Fitzgerald, Niamh M. | Schölin, Lisa | Barticevic, Nicolas | Zuzulich, Soledad | Poblete, Fernando | Norambuena, Pablo | Sacco, Paul | Ting, Laura | Beaulieu, Michele | Wallace, Paul George | Andrews, Matthew | Daley, Kate | Shenker, Don | Gallagher, Louise | Watson, Rod | Weaver, Tim | Bruguera, Pol | Oliveras, Clara | Gavotti, Carolina | Barrio, Pablo | Braddick, Fleur | Miquel, Laia | Suárez, Montse | Bruguera, Carla | Brown, Richard L. | Capell, Julie Whelan | Paul Moberg, D. | Maslowsky, Julie | Saunders, Laura A. | McCormack, Ryan P. | Scheidell, Joy | Gonzalez, Mirelis | Bauroth, Sabrina | Liu, Weiwei | Lindsay, Dawn L. | Lincoln, Piper | Hagle, Holly | Wallhed Finn, Sara | Hammarberg, Anders | Andréasson, Sven | King, Sarah E. | Vargo, Rachael | Kameg, Brayden N. | Acquavita, Shauna P. | Van Loon, Ruth Anne | Smith, Rachel | Brehm, Bonnie J. | Diers, Tiffiny | Kim, Karissa | Barker, Andrea | Jones, Ashley L. | Skinner, Asheley C. | Hinman, Agatha | Svikis, Dace S. | Thacker, Casey L. | Resnicow, Ken | Beatty, Jessica R. | Janisse, James | Puder, Karoline | Bakshi, Ann-Sofie | Milward, Joanna M. | Kimergard, Andreas | Garnett, Claire V. | Crane, David | Brown, Jamie | West, Robert | Michie, Susan | Rosendahl, Ingvar | Andersson, Claes | Gajecki, Mikael | Blankers, Matthijs | Donoghue, Kim | Lynch, Ellen | Maconochie, Ian | Phillips, Ceri | Pockett, Rhys | Phillips, Tom | Patton, R. | Russell, Ian | Strang, John | Stewart, Maureen T. | Quinn, Amity E. | Brolin, Mary | Evans, Brooke | Horgan, Constance M. | Liu, Junqing | McCree, Fern | Kanovsky, Doug | Oberlander, Tyler | Zhang, Huan | Hamlin, Ben | Saunders, Robert | Barton, Mary B. | Scholle, Sarah H. | Santora, Patricia | Bhatt, Chirag | Ahmed, Kazi | Hodgkin, Dominic | Gao, Wenwu | Merrick, Elizabeth L. | Drebing, Charles E. | Larson, Mary Jo | Sharma, Monica | Petry, Nancy M. | Saitz, Richard | Weisner, Constance M. | Young-Wolff, Kelly C. | Lu, Wendy Y. | Blosnich, John R. | Lehavot, Keren | Glass, Joseph E. | Williams, Emily C. | Bensley, Kara M. | Chan, Gary | Dombrowski, Julie | Fortney, John | Rubinsky, Anna D. | Lapham, Gwen T. | Forray, Ariadna | Olmstead, Todd A. | Gilstad-Hayden, Kathryn | Kershaw, Trace | Dillon, Pamela | Weaver, Michael F. | Grekin, Emily R. | Ellis, Jennifer D. | McGoron, Lucy | McGoron, Lucy
doi:10.1186/s13722-017-0087-8
PMCID: PMC5606215
3.  Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial 
Background
Substance use in pregnancy is associated with severe maternal and fetal morbidities and substantial economic costs. However, few studies have evaluated the cost-effectiveness of substance use treatment programs in pregnant women. The purpose of this study was to evaluate the economic impact of a behavioral intervention that integrated motivational enhancement therapy with cognitive behavioral therapy (MET-CBT) for treatment of substance use in pregnancy, in comparison with brief advice.
Methods
We conducted an economic evaluation alongside a clinical trial by collecting data on resource utilization and performing a cost minimization analysis as MET-CBT and brief advice had similar effects on clinical outcomes (e.g., alcohol and drug use and birth outcomes). Costs were estimated from the health care system’s perspective and included intervention costs, hospital facility costs, physician fees, and costs of psychotropic medications from the date of intake assessment until 3-month postpartum. We compared effects of MET-CBT on costs with those of brief advice using Wilcoxon rank sum tests.
Results
Although the integrated MET-CBT therapy had higher intervention cost than brief advice (median = $1297/participant versus $303/participant, p < 0.01), costs of care during the prenatal period, delivery, and postpartum period, as well as for psychotropic medications, were comparable between the two groups (all p values ≥ 0.55). There was no statistically significant difference in overall cost of care (median total cost = $26,993/participant for MET-CBT versus $27,831/participant for brief advice, p = 0.90).
Conclusions
The MET-CBT therapy and brief advice resulted in similar clinical outcomes and overall medical costs. Further research incorporating non-medical costs, targeting women with more severe substance use disorders, and evaluating the impact of MET-CBT on participants’ quality of life will provide additional insights.
Trial registration
ClinicalTrials.gov NCT00227903. Registered 27 September 2005.
doi:10.1186/s12884-017-1260-5
PMCID: PMC5341449  PMID: 28270105
Cost minimization analysis; Economic evaluation; Substance use; Pregnancy; Randomized controlled trial
4.  Are pregnancy planning and timing associated with preterm or small for gestational age births? 
Fertility and sterility  2015;104(6):1484-1492.
Objective
Investigate whether unplanned or poorly timed pregnancies (self-reported at enrollment) are associated with preterm or small for gestational age births.
Design
Prospective cohort of 2,654 pregnant women with individual assessments.
Setting
Offices (n=137) providing prenatal care in Connecticut and Western Massachusetts March 2005 to May 2009.
Patient(s)
Women less than 18 weeks estimated gestational age with a singleton pregnancy.
Intervention(s)
None.
Main Outcome Measure(s)
Preterm and small for gestational age births.
Results
In adjusted analyses, pregnancy planning was not significantly associated with preterm (Odds Ratio 1.18, 95%CI 0.85-1.65) nor small for gestational age birth (Odds Ratio 1.17, 95%CI 0.69-1.97). Similarly, poorly timed pregnancies were not significantly associated with preterm (Odds Ratio 0.85, 95%CI 0.53-1.38) nor small for gestational age birth (Odds Ratio 0.92, 95%CI 0.65-1.29). Combining pregnancy planning (yes/no) and timing (yes/no) into a 4-level category showed no significant association with preterm birth or small for gestational age.
Conclusion(s)
In a large cohort with antenatally assessed pregnancy planning and timing, outcome data collected from medical record abstraction, and robust analysis adjusting for multiple confounding factors including maternal demographics, medical conditions, and other risk factors, neither pregnancy planning nor pregnancy timing showed a significant association with preterm or small for gestational age infants. This study improves upon previous analyses that lack adjustment for confounding, and use retrospective self-reporting to assess pregnancy planning and timing, and preterm and small for gestational age birth. Findings may differ in higher risk populations with higher prevalence of preterm or small for gestational age births.
Capsule
Neither pregnancy planning nor timing showed a significant association with preterm or small for gestational age births in this large prospective cohort controlling for confounders.
doi:10.1016/j.fertnstert.2015.08.012
PMCID: PMC4663160  PMID: 26364840
preterm birth; small for gestational age; unplanned pregnancy
5.  Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Multi-Site, Double-Blind, Randomized, Placebo-Controlled Trial 
JAMA psychiatry  2015;72(10):1037-1044.
Importance
Serotonin reuptake inhibitors (SRIs) are efficacious treatments for premenstrual dysphoric disorder (PMDD) when given either daily or for half the menstrual cycle during the luteal phase. Preliminary studies suggest SRI treatment can be shortened to the interval between symptom-onset and the beginning of menses.
Objective
Determine the efficacy of symptom-onset dosing with sertraline for treatment of PMDD.
Design, Setting, and Participants
A double-blind, placebo-controlled trial conducted between 2007 and 2012 at three university medical centers. Women with PMDD were instructed to start pills at symptom onset and continue until the first few days of menses for six menstrual cycles.
Intervention
Placebo or sertraline 50–100 mg daily during the symptomatic interval
Main Outcome Measures
Premenstrual Tension Scale (PMTS)(Primary outcome measure), Inventory of Depressive Symptomatology– Clinician-Rated (IDS-C), Daily Record of Severity of Problems (DRSP) (total and subscales), Clinical Global Impression (CGI) scales and Michelson SSRI Withdrawal Symptoms Scale.
Results
125 participants were randomized to sertraline and 127 to placebo. The improvement in IDS-C scores was greater in the sertraline than the placebo group (F(6,1183)=2.6; p=.02; estimated mean difference between intake and endpoint of 5.14 points between groups (95% CI=1.97–8.31)). Group differences in PMTS scores were at a trend level (F(6,448)=2.1; p=.06; estimated mean difference from intake to endpoint of 1.88 between groups (95% CI=0.01–3.75) points). Compared to the placebo group, those assigned to sertraline showed greater improvement on the Total (estimated mean difference of 1.09 points (95% CI=0.96–1.25) and Anger/Irritability subscale of the DRSP (estimated mean difference of 1.22 (95% CI=1.05–1.41) and were more likely to respond ((77 (67%) for sertraline and 65 (53%) for placebo, (Χ2(1)=5.23; p=0.02)). The number of symptomatic days before pill taking diminished over time (F(5,814)=5.3, p<.001) in both groups with no group differences on the Michelson SSRI Withdrawal Symptoms Scale.
Conclusions and Relevance
Women with PMDD may benefit from SRI treatment limited to the interval between the onset of premenstrual symptoms and the first few days of menses. Abrupt treatment cessation at the end of each cycle does not increase risk of discontinuation symptoms.
Trial Registration
ClinicalTrials.gov Identifier NCT00536198
doi:10.1001/jamapsychiatry.2015.1472
PMCID: PMC4811029  PMID: 26351969
6.  Perinatal Substance Use: A Prospective Evaluation of Abstinence and Relapse 
Drug and alcohol dependence  2015;150:147-155.
Background
Substance use decreases in pregnancy but little prospective data are available on the rates of abstinence and relapse for specific substances. This study compared rates of abstinence in pregnancy and relapse postpartum for nicotine cigarettes, alcohol, marijuana, and cocaine.
Methods
Data from 152 women drawn from a randomized controlled trial comparing psychological treatments for substance use in pregnancy were analyzed. Self-reports of substance use and urine for toxicology testing throughout pregnancy and 3-months, 12-months and 24-months post-delivery were collected. Multivariate Cox models were used to compare rates of abstinence and relapse across substances.
Results
In pregnancy, 83% of all women achieved abstinence to at least one substance. The mean (SE) days to abstinence was 145.81 (9.17), 132.01 (6.17), 151.52 (6.24), and 148.91 (7.68) for cigarettes, alcohol, marijuana and cocaine, respectively. Participants were more likely to achieve abstinence from alcohol (HR 7.24 (95% CI 4.47-11.72), marijuana (HR 4.06; 95% CI 1.87-6.22), and cocaine (HR 3.41; 95% CI 2.53-6.51), than cigarettes. Postpartum, 80% of women abstinent in the last month of pregnancy relapsed to at least one substance. The mean days to relapse was 109.67 (26.34), 127.73 (21.29), 138.35 (25.46), and 287.55 (95.85) for cigarettes, alcohol, marijuana and cocaine, respectively. Relapse to cocaine was only 34% (HR 0.34; 95% CI 0.15-0.77) that of cigarettes.
Conclusions
Pregnancy-related abstinence rates were high for all substances except cigarettes. Postpartum relapse was common, with cocaine using women being less likely to relapse after attaining abstinence compared to women using cigarettes, alcohol or marijuana.
doi:10.1016/j.drugalcdep.2015.02.027
PMCID: PMC4387084  PMID: 25772437
Pregnancy; postpartum; drug use; smoking; relapse; abstinence
7.  Obstetric and Neonatal Outcomes After Antipsychotic Medication Exposure in Pregnancy 
Obstetrics and gynecology  2015;125(5):1224-1235.
Objective
Antipsychotic medications are used by increasing numbers of women of reproductive age. The safety of these medications during pregnancy has not been well-described. We undertook a systematic review and meta-analysis of the adverse obstetric and neonatal outcomes associated with exposure to antipsychotics during pregnancy.
Data Sources
PubMed, Reprotox, and ClinicalTrials.gov were searched to identify potential studies for inclusion.
Methods of Study Selection
Case-control or cohort studies estimating adverse birth outcomes associated with antipsychotic exposure during pregnancy were included. Pooled odds ratios (OR) were used for dichotomous outcomes and weighted mean differences (WMD) were used for infant birth weight and gestational age. Thirteen cohort studies, including 6,289 antipsychotic-exposed and 1,618,039 unexposed pregnancies were included.
Tabulation, Integration, and Results
Antipsychotic exposure was associated with an increased risk of major malformations (Absolute Risk Difference = 0.03, 95% confidence interval [CI] 0.00 – 0.05, p=0.04, Z = 2.06), heart defects (Absolute Risk Difference =0.01, 95% CI 0.00 – 0.01, p<0.001, Z = 3.44), preterm delivery (Absolute Risk Difference = 0.05, 95% CI 0.03 – 0.08, p<0.001, Z = 4.10), small-for-gestational-age births (Absolute Risk Difference = 0.05, 95% CI 0.02 – 0.09, p = 0.006, Z = 2.74), elective termination (Absolute Risk Difference = 0.09, 95% CI 0.05 – 0.13, p<0.001, Z = 4.69) and decreased birth weight (WMD=−57.89g, 95%CI −103.69g – −12.10g, p=0.01). There was no significant difference in the risk of major malformations (test for subgroup differences: χ2 = 0.07, df = 1, p = 0.79) between typical (OR = 1.55, 95% CI 1.21 – 1.99, p = 0.006) and atypical (OR = 1.39, 95% CI 0.66 – 2.93, p = 0.38) antipsychotic medications. Antipsychotic exposure was not associated with risk of large for gestational age births, stillbirth, and spontaneous abortion. Although antipsychotic exposure during pregnancy was associated with increased risk of adverse obstetric and neonatal outcomes, this association does not necessarily imply causation. This analysis was limited by the small number of included studies and limited adjustment in studies for possible confounders.
Conclusion
Women requiring antipsychotic treatment during pregnancy appear at higher risk of adverse birth outcomes, regardless of causation, and may benefit from close monitoring and minimization of other potential risk factors during pregnancy.
doi:10.1097/AOG.0000000000000759
PMCID: PMC4418034  PMID: 25932852
8.  Early Childhood Adversity and Pregnancy Outcomes 
Maternal and child health journal  2016;20(4):790-798.
Objectives
To examine the association between adverse childhood experiences (ACEs) and pregnancy outcomes; to explore mediators of this association including psychiatric illness and health habits.
Methods
Exposure to ACEs was determined by the Early Trauma Inventory Self Report Short Form; psychiatric diagnoses were generated by the Composite International Diagnostic Interview administered in a cohort of 2303 pregnant women. Linear regression and structural equation modeling bootstrapping approaches tested for multiple mediators.
Results
Each additional ACE decreased birth weight by 16.33 g and decreased gestational age by 0.063. Smoking was the strongest mediator of the effect on gestational age.
Conclusions
ACEs have an enduring effect on maternal reproductive health, as manifested by mothers’ delivery of offspring that were of reduced birth weight and shorter gestational age.
doi:10.1007/s10995-015-1909-5
PMCID: PMC4849279  PMID: 26762511
Maternal mental health; Trauma; Adverse childhood experiences; Pregnancy outcomes; Smoking
9.  Clinical Correlates of Prescription Opioid Analgesic Use in Pregnancy 
Maternal and child health journal  2015;19(3):548-556.
Objective
A 2012 committee opinion from the American College of Obstetricians and Gynecologists highlights the considerable increase in opioid addiction in recent years, yet little is known about clinical correlates of prescribed opioids among pregnant women. This study examines clinical and demographic factors associated with the use of opioid analgesics in pregnancy.
Methods
Data were derived from a prospective cohort study of pregnant women. Participants were administered the Composite International Diagnostic Interview to identify depressive and anxiety disorders and data on medication use were gathered at three assessment points and classified according to the Anatomical Therapeutic Chemical Code (ATC) classification system ATC group N02A. Participants included 2,748 English or Spanish speaking pregnant women.
Results
Six percent (n=165) of women used opioid analgesics at any point in pregnancy. More pregnant women using opioids met diagnostic criteria for major depressive disorder (16% vs. 8% for non users), generalized anxiety disorder (18% vs. 9% for non users), post-traumatic stress disorder (11% vs. 4% for non users) and panic disorder (6% vs. 4% for non users). Women who reported opioid use were also significantly more likely than non users to report using illicit drugs and almost three times as likely to report smoking cigarettes in the second or third trimester of pregnancy (4% and 23%, respectively) as compared to non-opioid users (0.5% and 8%).
Conclusion
The use of opioids in pregnancy was associated with higher levels of psychiatric comorbidity and use of other substances as compared to non-opioid users.
doi:10.1007/s10995-014-1536-6
PMCID: PMC4272915  PMID: 24951127
10.  Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study 
The Lancet. Psychiatry  2014;1(5):360-367.
Background
Progesterone modulates multiple brain functions implicated in the pathogenesis ofdrug addiction. During high endogenous progesterone states, women reduce use of cocaine. We sought to test whether progesterone replacement reduces cocaine use in postpartum women with a cocaine use disorder (CUD).
Methods
A 12-week, double-blind, parallel, randomized, placebo-controlled pilot trial with a 3-month post trial follow-up. 25 women within 12 weeks of deliverywere randomized to placeboand 25 to100 mgs of oral micronized progesterone, administered twice daily. Participants were recruited from obstetrical clinics. Randomization and allocation were performed by the study biostatistician. Attrition was 18% and the analysis included all50participants. Outcomes were self-reported days of cocaine use and positive urine toxicology assays for cocaine metabolites.
Findings
Participants randomized to placebo compared to progesterone had increased likelihood of cocaine use per week (RR=1·19; 95% confidence interval (CI)=1·05 to 1·36; p<0·01). At the three-month post trial visit the difference between groups was not significant (Likelihood RatioΧ2 =5·16; P=·08). There were no group differences in rates of submission of a positive urine test. A post hoc analysis showed a higher rate of relapse for participants randomized to placebo (HR=4·71; 95% CI= 1·09 to 20·5). We did not observe groups differences in the rate of adverse events.
Interpretation
These preliminary findings support the promise of progesterone treatment in postpartum women with a CUD and could constitute a therapeutic break through.
Funding
US National Institute on Drug Abuse; Veterans Administration
doi:10.1016/S2215-0366(14)70333-5
PMCID: PMC4199242  PMID: 25328863
Cocaine Abuse; Cocaine Dependence; Cocaine Use Disorder; Postpartum; Progesterone; Obstetrics and Gynecology; Women
11.  See One, Do One, Order One: a study protocol for cluster randomized controlled trial testing three strategies for implementing motivational interviewing on medical inpatient units 
Background
General medical hospitals provide care for a disproportionate share of patients who abuse or are dependent upon substances. This group is among the most costly to treat and has the poorest medical and addiction recovery outcomes. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance use problems in that patients are accessible, have time for an intervention, and are often admitted for complications related to substance use that renders hospitalization a “teachable moment.”
Methods/Design
This randomized controlled trial will examine the effectiveness of three different strategies for integrating motivational interviewing (MI) into the practice of providers working within a general medical inpatient hospitalist service: (1) a continuing medical education workshop that provides background and “shows” providers how to conduct MI (See One); (2) an apprenticeship model involving workshop training plus live supervision of bedside practice (Do One); and (3) ordering MI from the psychiatry consultation-liaison (CL) service after learning about it in a workshop (Order One). Thirty providers (physicians, physician assistants, nurses) will be randomized to conditions and then assessed for their provision of MI to 40 study-eligible inpatients. The primary aims of the study are to assess (1) the utilization of MI in each condition; (2) the integrity of MI when providers use it on the medical units; and (3) the relative costs and cost-effectiveness of the three different implementation strategies.
Discussion
If implementation of Do One and Order One is successful, the field will have two alternative strategies for supporting medical providers’ proficient use of brief behavioral interventions, such as MI, for medical inpatients who use substances problematically.
Trial registration
Clinical Trials.gov (NCT01825057)
doi:10.1186/s13012-015-0327-9
PMCID: PMC4589113  PMID: 26420671
Primary care integration; Implementation strategies; Motivational interviewing
12.  Pregnancy-specific Stress, Preterm Birth, and Gestational Age Among High-risk Young Women 
Objective
There is evidence that pregnancy-specific stress is associated with preterm birth. The purpose of this study is to examine the association between change in pregnancy-specific stress over the course of pregnancy and birth outcomes (i.e., preterm birth and gestational age) in an understudied, but vulnerable group using a theoretically-derived model.
Methods
Multivariate linear and logistic regression techniques were used to examine the association between pregnancy-specific stress (measured in second and third trimester) and length of gestation (i.e. preterm birth and gestational age) among a sample of 920 Black and/or Latina adolescent and young women.
Results
Second trimester pregnancy-specific stress was not associated with preterm birth or gestational age. Third trimester pregnancy-specific stress was associated with preterm birth, but not with gestational age. Change in pregnancy-specific stress between second and third trimester was significantly associated with increased likelihood of preterm delivery and shortened gestational age, even after controlling for important biological, behavioral, psychological, interpersonal, and sociocultural risk factors.
Conclusions
Findings emphasize the importance of measuring pregnancy-specific stress across pregnancy, as the longitudinal change from second to third trimester was significantly associated with length of gestation measured both as a dichotomous variable (preterm birth) and a continuous variable (gestational age). Furthermore, this is the first study to observe the association of pregnancy-specific stress with length of gestation in this understudied population–unique in age, race, and ethnicity.
doi:10.1037/a0034586
PMCID: PMC4104268  PMID: 24447189
pregnancy-specific stress; pregnancy anxiety preterm birth; gestational age; birth outcomes
13.  Perinatal Smoking and Depression in Women with Concurrent Substance Use 
Addictive behaviors  2013;39(4):749-756.
Objective
The purpose of this report was to examine the course of smoking among pregnant women with concurrent substance use, and to assess the impact of depression on smoking.
Methods
Data were gathered as part of a randomized controlled trial assessing the efficacy of substance abuse treatment in pregnant women. Women (n=176) were recruited before 28 completed weeks of pregnancy, and followed until 3 months postpartum. Depression was assessed using the Inventory of Depressive Symptomatology and the MINI Neuropsychiatric Interview. Our outcome was the average number of cigarettes smoked per day. Linear mixed effects regression was used to measure differential changes in smoking.
Results
66% of women smoked in the three months before pregnancy, 42% of pre-pregnancy smokers achieved abstinence before delivery and 60% of the baseline cohort smoked postpartum. Smoking did not differ significantly between depressed and non-depressed groups. After delivery both groups increased smoking at similar rates.
Conclusion
Smoking was common among our cohort of pregnant women with a history of substance use. Women were able to discontinue or decrease smoking during pregnancy, but were likely to resume or increase smoking postpartum. Having clinically significant depressive symptoms or a diagnosis of depression did not have an obvious effect on smoking behaviors.
doi:10.1016/j.addbeh.2013.12.008
PMCID: PMC3944019  PMID: 24447885
14.  A meta-analysis of the relationship between antidepressant use in pregnancy and the risk of preterm birth and low birth weight 
General hospital psychiatry  2013;36(1):10.1016/j.genhosppsych.2013.08.002.
doi:10.1016/j.genhosppsych.2013.08.002
PMCID: PMC3877723  PMID: 24094568
antidepressants; pregnancy; prenatal; antenatal; adverse birth outcomes; low birth weight; preterm birth
15.  Fluoxetine Increases Suicide Ideation Less than Placebo During Treatment of Adults with Minor Depressive Disorder 
Journal of psychiatric research  2013;47(9):1199-1203.
Objective
Some reports suggest an increase in suicide ideations and behaviors in patients treated with antidepressants. This is an analysis of the impact of fluoxetine on suicide ideations in outpatients with Minor Depressive Disorder.
Methods
Research subjects were adult outpatients with Minor Depressive Disorder (N=162), who received fluoxetine or placebo in a prospective, 12-week, double blind randomized trial. The research participants were evaluated weekly with standard rating scales that included 4 suicide-related items; item 3 of the Hamilton Rating Scale for Depression (HRSD), item 18 of Inventory of Depressive Symptomatology (IDS-C), and items 15 and 59 of the Hopkins Symptom Checklist (SCL-90). Clinically significant intensification of suicide ideation was defined as an increase of ≥2 on any of these items.
Results
Overall 60/162 subjects (37%) had an increase of ≥1 point during treatment and 17/162 (10.5%) of ≥2 points on at least one suicide item, with 12/81 (14.8%) placebo and 5/81 (6.2%) fluoxetine treated subjects having a ≥2 point gain. Of the study participants with baseline suicide ideation, 9/22 (40.9%) placebo and 3/24 (12.5%) fluoxetine treated had ≥2 point increase (p=0.04). Survival analysis revealed that subjects on placebo were significantly more likely (p=0.050) to experience a ≥2 point increase on one or more item, a difference that emerged early and continued throughout the 12-week trial.
Conclusions
Compared to placebo, fluoxetine was not associated with a clinically significant increase in suicide ideation among adults with Minor Depressive Disorder during 12 weeks of treatment.
doi:10.1016/j.jpsychires.2013.05.025
PMCID: PMC3729337  PMID: 23786912
Minor Depressive Disorder; fluoxetine; antidepressant; treatment emergent suicide ideation
16.  Antidepressant Use in Pregnant and Postpartum Women 
Women in their reproductive years are at increased risk of experiencing depressive and anxiety disorders. As such, it is likely that pregnant women will undergo treatment with antidepressants. We review the risk of adverse pregnancy outcomes and perinatal and neonatal complications of the offspring related to in utero exposure to antidepressants. The literature shows that antidepressant exposure is associated with fetal growth changes and shorter gestations, although effects are small. There are a number of reports of transitory neonatal signs after exposure to antidepressants. No specific pattern of malformations has been consistently associated with antidepressants, with the possible exception of paroxetine and cardiac malformations. There is inconclusive evidence of a link between antidepressants in late pregnancy and persistent pulmonary hypertension in the newborn. While antidepressant use in pregnancy is well studied, confounding factors that can adversely affect pregnancy and birth outcomes may contribute to some of the findings.
doi:10.1146/annurev-clinpsy-032813-153626
PMCID: PMC4138492  PMID: 24313569
Pregnancy; Antidepressants; Serotonin Reuptake Inhibitors; Tricyclic Antidepressants; Adverse Effects
17.  Pregnant Women With Posttraumatic Stress Disorder and Risk of Preterm Birth 
JAMA psychiatry  2014;71(8):897-904.
IMPORTANCE
Posttraumatic stress disorder (PTSD) occurs in about 8% of pregnant women. Stressful conditions, including PTSD, are inconsistently linked to preterm birth. Psychotropic treatment has been frequently associated with preterm birth. Identifying whether the psychiatric illness or its treatment is independently associated with preterm birth may help clinicians and patients when making management decisions.
OBJECTIVE
To determine whether a likely diagnosis of PTSD or antidepressant and benzodiazepine treatment during pregnancy is associated with risk of preterm birth. We hypothesized that pregnant women who likely had PTSD and women receiving antidepressant or anxiolytic treatment would be more likely to experience preterm birth.
DESIGN, SETTING, AND PARTICIPANTS
Longitudinal, prospective cohort study of 2654 women who were recruited before 17 completed weeks of pregnancy from 137 obstetrical practices in Connecticut and Western Massachusetts.
EXPOSURES
Posttraumatic stress disorder, major depressive episode, and use of antidepressant and benzodiazepine medications.
MAIN OUTCOMES AND MEASURES
Preterm birth, operationalized as delivery prior to 37 completed weeks of pregnancy. Likely psychiatric diagnoses were generated through administration of the Composite International Diagnostic Interview and the Modified PTSD Symptom Scale. Data on medication use were gathered at each participant interview.
RESULTS
Recursive partitioning analysis showed elevated rates of preterm birth among women with PTSD. A further split of the PTSD node showed high rates for women who met criteria for a major depressive episode, which suggests an interaction between these 2 exposures. Logistic regression analysis confirmed risk for women who likely had both conditions (odds ratio [OR], 4.08 [95% CI, 1.27–13.15]). For each point increase on the Modified PTSD Symptom Scale (range, 0–110), the risk of preterm birth increased by 1% to 2%. The odds of preterm birth are high for women who used a serotonin reuptake inhibitor (OR, 1.55 [95% CI, 1.02–2.36]) and women who used a benzodiazepine medication (OR, 1.99 [95% CI, 0.98–4.03]).
CONCLUSIONS AND RELEVANCE
Women with likely diagnoses of both PTSD and a major depressive episode are at a 4-fold increased risk of preterm birth; this risk is greater than, and independent of, antidepressant and benzodiazepine use and is not simply a function of mood or anxiety symptoms.
doi:10.1001/jamapsychiatry.2014.558
PMCID: PMC4134929  PMID: 24920287
18.  Costs of a Motivational Enhancement Therapy Coupled with Cognitive Behavioral Therapy versus Brief Advice for Pregnant Substance Users 
PLoS ONE  2014;9(4):e95264.
Objectives
To determine and compare costs of a nurse-administered behavioral intervention for pregnant substance users that integrated motivational enhancement therapy with cognitive behavioral therapy (MET-CBT) to brief advice (BA) administered by an obstetrical provider. Both interventions were provided concurrent with prenatal care.
Methods
We conducted a micro-costing study that prospectively collected detailed resource utilization and unit cost data for each of the two intervention arms (MET-CBT and BA) within the context of a randomized controlled trial. A three-step approach for identifying, measuring and valuing resource utilization was used. All cost estimates were inflation adjusted to 2011 U.S. dollars.
Results
A total of 82 participants received the MET-CBT intervention and 86 participants received BA. From the societal perspective, the total cost (including participants’ time cost) of the MET-CBT intervention was $120,483 or $1,469 per participant. In contrast, the total cost of the BA intervention was $27,199 or $316 per participant. Personnel costs (nurse therapists and obstetric providers) for delivering the intervention sessions and supervising the program composed the largest share of the MET-CBT intervention costs. Program set up costs, especially intervention material design and training costs, also contributed substantially to the overall cost.
Conclusions
Implementation of an MET-CBT program to promote drug abstinence in pregnant women is associated with modest costs. Future cost effectiveness and cost benefit analyses integrating costs with outcomes and benefits data will enable a more comprehensive understanding of the intervention in improving the care of substance abusing pregnant women.
doi:10.1371/journal.pone.0095264
PMCID: PMC3997437  PMID: 24760017
19.  ISPMD consensus on the management of premenstrual disorders 
Archives of women's mental health  2013;16(4):279-291.
The second consensus meeting of the International Society for Premenstrual Disorders (ISPMD) took place in London during March 2011. The primary goal was to evaluate the published evidence and consider the expert opinions of the ISPMD members to reach a consensus on advice for the management of premenstrual disorders. Gynaecologists, psychiatrists, psychologists and pharmacologists each formally presented the evidence within their area of expertise; this was followed by an in-depth discussion leading to consensus recommendations. This article provides a comprehensive review of the outcomes from the meeting. The group discussed and agreed that careful diagnosis based on the recommendations and classification derived from the first ISPMD consensus conference is essential and should underlie the appropriate management strategy. Options for the management of premenstrual disorders fall under two broad categories, (a) those influencing central nervous activity, particularly the modulation of the neurotransmitter serotonin and (b) those that suppress ovulation. Psychotropic medication, such as selective serotonin reuptake inhibitors, probably acts by dampening the influence of sex steroids on the brain. Oral contraceptives, gonadotropin-releasing hormone agonists, danazol and estradiol all most likely function by ovulation suppression. The role of oophorectomy was also considered in this respect. Alternative therapies are also addressed, with, e.g. cognitive behavioural therapy, calcium supplements and Vitex agnus castus warranting further exploration.
doi:10.1007/s00737-013-0346-y
PMCID: PMC3955202  PMID: 23624686
Premenstrual syndrome; Premenstrual dysphoric disorder; Variant premenstrual disorder; Core premenstrual disorder; Premenstrual exacerbation; PMS; PMDD
20.  Neurobehavioral assessment of infants born at term and in utero exposure to serotonin reuptake inhibitors 
Early human development  2012;89(2):81-86.
Background
Some studies report neurobehavioral symptoms in neonates exposed to serotonin reuptake inhibitors (SRIs) in utero. However, maternal psychiatric illness during the last trimester of pregnancy, as a confounding factor, has not always been assessed.
Aims
In this prospective study we compared neurobehavioral complications among neonates who were born to euthymic women who either took or did not take an SRI during the last trimester of pregnancy.
Study design
Exposed and unexposed infants were assessed for: 1) temperament as measured by the Neonatal Behavioral Assessment Scale (NBAS); 2) activity via Actiwatch electronic monitoring; 3) sleep state using trained observer ratings; and 4) perinatal complications through medical record review. T-tests, Fisher's exact tests, and analyses of covariance were used to assess the relationship between clinical and neurobehavioral factors and exposure status.
Subjects
67 infants (61 controls and 6 exposed to SRIs).
Outcome measures
Neonatal Assessment Behavioral Scale, APGAR scores, infant sleep state (% sleep, % wakeful), startles and tremulousness, gestational age, birth weight, and head circumference.
Results
Infants exposed to SRIs in the third trimester had poorer motor development, lower 5-minute APGAR scores, and shorter mean gestational age as compared to unexposed infants.
Conclusion
Results of this study show differences in autonomic and gross motor activity between neonates who were or were not exposed to SRIs in utero after controlling for active maternal psychiatric illness. Future longitudinal work should compare longer term outcomes of exposed and unexposed infants of depressed mothers.
doi:10.1016/j.earlhumdev.2012.08.001
PMCID: PMC3921021  PMID: 22999988
Selective serotonin reuptake inhibitors; Perinatal depression
21.  DEPRESSION and SEROTONIN REUPTAKE INHIBITOR TREATMENT AS RISK FACTORS FOR PRETERM BIRTH 
Epidemiology (Cambridge, Mass.)  2012;23(5):677-685.
Background
Major depressive disorder as well as the use of serotonin reuptake inhibitors in pregnancy have been associated with preterm birth. Studies that have attempted to separate effects of illness from treatment have been inconclusive. We sought to explore the separate effects of serotonin reuptake inhibitor use and major depressive episodes in pregnancy on risk of preterm birth.
Methods
We conducted a prospective cohort study of 2793 pregnant women, oversampled for a recent episode of major depression or use of a serotonin reuptake inhibitor. We extracted data on birth outcomes from hospital charts and used binary logistic regression to model preterm birth (<37 weeks’ gestation). We used ordered logistic regression to model early (<34 weeks’ gestation) or late (34-36 weeks) preterm birth, and we used nominal logistic regression to model preterm birth antecedents (spontaneous preterm labor/preterm premature rupture of membranes/preterm for medical indications/term).
Results
Use of a serotonin reuptake inhibitor, both with (odds ratio=2.1 [95% confidence interval=1.0—4.6]) and without (1.6=[1.0—2.5]) a major depressive episode, was associated with preterm birth. A major depressive episode without serotonin reuptake inhibitor use (1.2; [0.68—2.1]) had no clear effect on preterm risk. None of these exposures was associated with early preterm birth. Use of serotonin reuptake inhibitors in pregnancy was associated with increases in spontaneous but not medically indicated preterm birth.
Conclusions
Serotonin reuptake inhibitor use increased risk of preterm birth. Although the effect of a major depressive episode alone was unclear, symptomatic women undergoing antidepressant treatment had elevated risk.
doi:10.1097/EDE.0b013e31825838e9
PMCID: PMC3415566  PMID: 22627901
22.  Motivational Enhancement Therapy Coupled with Cognitive Behavioral Therapy versus Brief Advice; A Randomized Trial for Treatment of Hazardous Substance Use in Pregnancy and After Delivery 
General hospital psychiatry  2012;34(5):439-449.
Objective
To compare the efficacy of motivational enhancement therapy coupled with cognitive behavioral therapy (MET-CBT) to brief advice for treatment of substance use in pregnancy.
Method
This was a randomized, parallel, controlled trial that was yoked to prenatal care and delivered at hospital outpatient clinics. We enrolled 168 substance using women who had not yet completed an estimated 28 weeks of pregnancy. Obstetrical clinicians provided brief advice and study nurses administered manualized MET-CBT. The primary outcome was percentage of days in the prior 28 days, that alcohol and/or drugs were used immediately before and three months post delivery.
Results
There were no significant differences across groups in terms of self-reported percentage of days that drugs or alcohol were used prior to and three months post delivery. Biological measures showed similar results. There was a trend (p=0.08) for lower risk of preterm birth among those who received MET-CBT.
Conclusions
The tested interventions had similar therapeutic effects. Hence, both treatments may be suitable for pregnant substance users, depending on the population, setting, and provider availability. Interventions that are intensified after delivery may decrease postpartum ‘rebound’ effects in substance misuse.
doi:10.1016/j.genhosppsych.2012.06.002
PMCID: PMC3428516  PMID: 22795046
23.  Perinatal Depression and Birth Outcomes in a Healthy Start Project 
Maternal and child health journal  2011;15(3):401-409.
Given the risk of adverse perinatal outcomes associated with a depressive disorder, the Health Resources and Services Administration’s (HRSA) Maternal and Child Health Bureau (MCHB) from 2001–2005 devoted resources through the Federal Healthy Start Initiative to screen pregnant women for depression and link them with services. In this report, we present the evaluation of a program that screened for depression and provided services for women with depressive symptoms or psychiatric distress in pregnancy to assess whether the program was associated with a reduction in babies born low birth weight, small for gestational age, or preterm. The program impact was examined among 1,100 women in three cohorts enrolled from 2001–2005 that included: (1) subjects recruited prior to the inception of the Healthy Start Initiative; (2) subjects enrolled in the Healthy Start Initiative; and (3) a comparison group recruited during the project period but not enrolled in the Healthy Start Initiative. After adjustment for covariates, women with probable depression were over one and a half times more likely to give birth to a preterm baby than non depressed women. Neither adjusted nor unadjusted risks for delivery of preterm, low birth weight or small for gestational age infants were significantly lower for women enrolled in Healthy Start as compared to women not enrolled in Healthy Start. However, regardless of enrollment in Healthy Start, women who delivered babies after the Healthy Start program began were 85% less likely to deliver preterm babies than women giving birth before the program began. Depression status conferred increased risk of adverse birth outcomes, results that were not altered by participation in the Healthy Start program. We cannot exclude the possibility that the community activities of the Healthy Start program promoted increased attention to health issues among depressed women and hence enhance birth outcomes.
doi:10.1007/s10995-010-0595-6
PMCID: PMC3757503  PMID: 20300813
Perinatal depression; Birth outcomes; Healthy start; Evaluation
24.  Self-report of illicit substance use versus urine toxicology results from at-risk pregnant women 
Journal of substance use  2011;16(5):372-389.
Introduction
Many factors comprise a patient's decision to disclose use of drugs. Pregnant women may report drug use because they would like help with their addiction but the stigma associated with drug use may dampen their willingness to disclose. Knowledge about the accuracy of self-reported drug use as compared to urine toxicology screens can assist clinicians in the management of substance use in pregnancy.
Method
We compared the urine toxicology screens and self-reported use of marijuana or cocaine for 168 women enrolled in an integrated obstetrical/substance abuse treatment program. We stratified by various periods of self-reported use and race and utilized Cohen's kappa to measure overall agreement between self-report and toxicology tests.
Results
Most women with a positive toxicology screen reported use in the past 28 days (78% for marijuana, 86% for cocaine). However, many women reported their most recent use to be outside of the assays’ detection window (14% for marijuana, 57% for cocaine). We did not find differences in self-report for women with positive urine between Whites and non-Whites (p = 1.00). Agreement over the previous month was good (Kappa = 0.74 and 0.70 for marijuana and cocaine, respectively.)
Summary
A question about use of marijuana or cocaine during the preceding month rather than the prior few days may be a better indicator of use.
doi:10.3109/14659891003721133
PMCID: PMC3744375  PMID: 23956685
Cocaine; marijuana; self-disclosure; urine toxicology

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