Clinical Care Of Pregnant Women Research Articles

Canadian surveillance of COVID-19 in pregnancy: Epidemiology and maternal and infant outcomes

To describe the Canadian approach to rapid epidemic surveillance through the CANCOVID-Preg network. To assess the burden of COVID-19 in pregnancy and associated maternal and infant outcomes in Canada. We mobilized an established network of care providers in response to the global pandemic due to a paucity of data on COVID-19 in pregnancy. We engaged leads in each province/territory to develop an approach for identification of all cases of SARS-CoV-2 in pregnancy and collection of outcome data for women and infants. Women with documented infection in pregnancy are identified by public health and/or clinical identification and data collection is prospective via medical records. Data collection forms were designed to ensure harmonization between Canadian provinces/territories and with international networks (e.g. COVI-Preg, WHO). In Canada, it is not recommended that COVID-19 affected mother-infant pairs are separated. We will provide data to evaluate this practice. Data will be described using descriptive statistics. If sample size allows, comparisons of maternal/fetal outcomes will be made among variables (e.g., symptom severity, ventilation, treatments, maternal age, education, etc.) using regression analyses. The CANCOVID-Preg network and national surveillance for COVID-19 in pregnancy was rapidly implemented. Within 2 weeks of pandemic declaration, national meetings and study protocol development began. The first all-member meeting occurred at 7 weeks when organization structures had been launched in all regions. Dedicated funding was secured by 3 months. Between March 1, 2020 to June 24, 2020, 307 cases were identified in Canada, with regional distribution proportional to population. As of May 30, 2020, data have been collected for 22 pregnancies in British Columbia (BC) and 27 in Ontario (ON). In BC, mean gestational age at SARS-CoV-2 diagnosis was 20.3 weeks (±9.9, range: 5.3 - 38.3). Among those with detailed data, 31.6% (6/19) had a known positive contact in the community; 2 reported travel before diagnosis. Among 46 pregnancies (BC & ON), the most frequently documented symptoms were cough (37.0%), fever (32.6%). Two (9%) BC cases have been hospitalized due to COVID-19; no ICU admission or mechanical ventilation. Two (9%) BC and 21 (78%) ON cases have delivered. One infant (of 12 with results) in ON tested positive for SARS-CoV-2 and may represent a vertical transmission. Updated data will be presented at the IDSOG Annual Meeting. This national surveillance project was largely enabled by national care provider networks as well as provincially dedicated database software and routine perinatal data collection. Our team will provide national data on COVID-19 in pregnancy to support clinical care of pregnant women and their infants.

Differences in body mass index based on self-reported versus measured data from women veterans.

SummaryObjectiveThe objective was to compare differences in body mass index (BMI) calculated with self‐reported versus clinically measured pre‐conception data from women veterans in California.MethodsVeterans Health Administration (VHA) and California state birth certificate data were used to develop a cohort of women who gave birth from 2007–2012 and had VHA data available to calculate BMI (N = 1,326 mothers, 1,473 births). Weighted Kappa statistics assessed concordance between self‐reported and measured BMI. A linear mixed‐effects model with maximum likelihood estimation, adjusted for mother as a random effect, assessed correlates of differences in BMI.ResultsMean BMI was in the overweight range based on self‐reported (26.2 kg/m2, SD: 5.2) and measured (26.8 kg/m2, SD: 5.2) data. Weighted Kappa statistics indicated good agreement between self‐reported and measured BMI (0.73, 95% CI: 0.70, 0.76). Compared to the normal weight group, groups with overweight or obesity were significantly more likely to have lower BMIs when calculated using self‐reported versus measured heights and weights, in unadjusted and adjusted models. The finding was pronounced for class 3 obesity, which was associated with a BMI underestimation of 6.4 kg/m2.ConclusionsEpidemiologic research that guides the clinical care of pregnant women should account for potential under‐estimation of BMI in heavier women, and perform direct measurement where feasible.

Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks' gestation in naturally conceived and uncomplicated pregnancies resulting in live births.

Background Pregnancy introduces major physiological changes that also alter biochemical analytes. Maternal and perinatal health can be optimized by early intervention and therefore, pregnancy-specific reference intervals (RIs) for the local population are warranted. While the second and third trimester-specific changes are well described, the first trimester is less well characterized. We therefore wanted to facilitate early detection of abnormalities by generating first trimester reference values for 29 common analytes. Methods In a prospective early pregnancy (PEP) cohort (2016-2017), 203 pregnant women were recruited from 4 to 8 weeks' gestation. Consecutive blood samples were drawn every 2 weeks until an ongoing second trimester pregnancy (n = 164) or a miscarriage (n = 39) occurred. After exclusion of women with complicated pregnancies or deliveries (n = 42), 122 women were included. The serum samples collected at <6, 6-8, 8-10, 10-12 and >12 weeks' gestation were analyzed for 29 common analytes. Subsequently the RIs were calculated according to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommendations (2.5-97.5th percentiles) and compared with the conventional RIs for non-pregnant women. Results Human chorionic gonadotropin (hCG), progesterone (P4), estradiol (E2), pregnancy-associated plasma protein A (PAPP-A), cancer antigen 125 (CA125), thyroid stimulating hormone (TSH), creatinine (CREA) and albumin (ALB) showed an early pregnancy-dependent change compared with conventional limits. For ALB the change was seen at 5.5 weeks' gestation. Conclusions We report gestational age-specific RIs available from the early part of the first trimester applicable to everyday clinical care of pregnant women. Well-known alterations of RIs seen in later trimesters are also observed in the first.

Challenges of Zika Virus Testing in Pregnancy in the Setting of Local Mosquito-Borne Transmission

BackgroundZika Virus (ZIKV) infection in pregnancy is a major clinical concern. The CDC recommended that pregnant women living in an area with a ZIKV travel notice undergo ZIKV screening in the first and second trimesters of pregnancy. This study investigated the consequences of this screening on clinical management.MethodsAn IRB approved retrospective chart review was conducted using laboratory records of ZIKV testing on pregnant patients from January through December 2016 at multiple tertiary care centers in Miami, FL. Serum and/or urine samples were collected, based on CDC guidelines at the time, and evaluated for PCR and/or IgM evidence of ZIKV infection. Positive ZIKV PCR results indicated acute phase of infection. Previous infection was suggested by positive IgM antibody, but required confirmatory ZIKV plaque reduction neutralization testing (PRNT) testing due to IgM antibody cross reactivity with other flaviviruses.ResultsDuring 2016, 2,327 pregnant women were screened for ZIKV infection. At the peak in August 2016, 607 (26%) patients were tested and only 31 (5.1%) tests resulted within the month. Of those screened, 113 (4.85%) women tested positive for ZIKV PCR and/or IgM. In October 2016, 40 (35.4%) positive screening tests were received, the most positives resulting in a month. Confirmatory ZIKV PRNT testing was performed on those who were ZIKV IgM positive and PCR negative, with a total of 92 results received. Eighty-eight women were considered positive, 49 confirmed with positive titers (≥10). There were 28 women with negative titers (< 10), thus a false positive ZIKV screening rate of 30.4%, and 15 results were pending. Of women with false positive IgM screening, a median of 1 (range 0–4) additional ultrasound was done between receipt of the initial positive ZIKV screening and the subsequent receipt of the negative PRNT testing. Delays of results led to 21 (24%) positive tests reported after delivery and hospital discharge. Additionally, 18 (20.5%) women who tested PRNT positive had their originating sample drawn during admission for delivery with results available only after discharge.ConclusionBoth delays in ZIKV testing results and false positive screening with ZIKV IgM led to challenges in counseling and clinical care of pregnant women living in an area of ongoing ZIKV transmission.Disclosures All authors: No reported disclosures.

2255

OBJECTIVES/SPECIFIC AIMS: (1) Characterize the prevalence and initial pharmacological management of chronic pain syndromes during pregnancy in a women’s mental health program. (2) Describe the severity and qualitative characteristics of chronic pain during pregnancy and the acute postpartum period. (3) Compare obstetrical and neonatal outcomes between pregnant women with and without chronic pain syndromes. METHODS/STUDY POPULATION: A chart review was conducted to identify all pregnant women who presented for an initial evaluation to the Women’s Mental Health Program (WMHP) at the University of Arkansas for Medical Sciences from July 2013 to June 2016. We excluded respondents &lt;18 years of age or who did not consent to having their information used for research purposes. Demographic information, past and current medical histories, and medication history were obtained from written and electronic medical records. Chronic pain complaints and medication history are presented as counts and percentages. In an ongoing prospective, longitudinal study of pregnant women with chronic pain, women are enrolled before 20 weeks gestation and followed throughout pregnancy and the first 3 months postpartum. Study visits occur at 4-week intervals; and pain characteristics, analgesic exposures, other medications, and depressive measures are collected. Obstetrical and neonatal outcomes are obtained following delivery. Subjects will be compared based on pain types (ie, neuropathic pain, non-neuropathic pain, and controls) and treatment exposures (eg, +/− opioids). Primary outcome measures include visual analog scale (VAS). Secondary outcome measures include other pain and depression assessments. Data will be analyzed using SAS 9.4. A p-value of&lt;0.05 was considered statistically significant. RESULTS/ANTICIPATED RESULTS: (1) Chronic pain conditions were reported by 28.2% (44/156) of the initial referrals to the WMHP. (2) 95.5% of respondents with chronic pain were taking at least 1 medication, and 59.5% were taking 2 or more medications. Mean number of medications used were 2.6±2.1.3. The most common medications reported were acetaminophen (43.2%), opioids (43.2%), and sedative/hypnotics (36.4%). Non-pharmacological therapy (eg, physical therapy and transcutaneous electrical nerve stimulation) was reported by 20.5% of respondents. (4) We anticipate that measures of pain severity will increase in pregnancy, peak in the third trimester, and decline in the postpartum period. (5) We foresee that the prospective results will confirm the chart review as indicated by a higher rate of medication exposures during pregnancy, including non-analgesic medications in the women with chronic pain syndromes. (6) We expect women with chronic pain syndromes to have a higher rate of obstetrical complications, specifically pre-term delivery and operative delivery. (7) Finally, we anticipate that chronic pain syndromes and management will result in a higher rate of neonatal complications, specifically neonatal intensive care unit admission, neonatal respiratory problems, and small for gestational age infants. DISCUSSION/SIGNIFICANCE OF IMPACT: Chronic pain syndromes are prevalent in more than one-quarter of pregnant women in our study with the majority of women using pharmacological agents to manage their condition. This prevalence is greater or equal to than other common obstetrical conditions, such as gestational diabetes or preterm delivery. The novel prospective data will be germane to the clinical care of pregnant women with chronic pain disorders. Clinical practice will be better informed by our data regarding the potential impact of chronic pain and its management on pregnancy course and perinatal outcomes. These data will provide the initial foundation for the development of treatment guidelines for the management of chronic pain syndromes during the perinatal period.

Drug Labeling in the Practice of Obstetric Anesthesia

This commentary outlines the current drug labeling practices that potentially compromise the clinical care of pregnant women and their children. We highlight the need for drug manufacturers and lawmakers to change the status quo and consider practices and regulations that will provide much-needed guidance to clinicians on the safe administration of drugs to certain populations such as pregnant and nursing women. Current practices have de facto contributed to a situation in which evidence is inadequate for individual physicians and patients to weigh the risks and benefits of drug administration and make informed decisions for drug use during pregnancy and lactation.

Challenges in cardiology research in pregnancy.

Research in pregnancy is challenging as it involves a special 'vulnerable' group due to the involvement of the mother and the fetus. These challenges, which are inherent in studying pregnancy in physiologic and pathologic states, have contributed to the scant research in pregnancy. Until recently, most studies in pregnancy were nonrandomized and retrospective in nature, representing prevailing clinical standards of practice and clinicians' biases. Prospective studies were generally limited to single centers, comprising of small sample sizes and were observational in nature, rather than randomized studies involving therapy. Ethical and legal factors, research mandates, patient factors, the protracted nature of pregnancy, institutional commitment to research, interdisciplinary clinical and research collaboration, funding support, administrative issues and the level of involvement of national cardiac and obstetric and gynecological societies have been barriers to research in pregnancy in developed countries. Even prospective observational studies are difficult to perform due the difficulties involved with obtaining consent, study recruitment and follow-up. Misconceptions regarding research have led to a lack of participation by women. The longitudinal nature of prospective studies in pregnancy, the problems associated with enrolling women before pregnancy and in the first trimester and the failure to understand the commitment required by the patient, as well as many social factors, have led to increased drop-out rates during pregnancy, as well as difficulty with follow-up in the post-partum state. These factors, along with the failure to supplement funding support due to longer study periods than anticipated, have led to studies of small sample sizes. Understanding patient factors that lead to a lack of participation in research or dropping out following initial consent could help make research participation more conducive for pregnant women. The involvement of national societies in the planning and funding of multicenter studies, interdepartmental and interinstitutional collaboration, institutional and extramural funding support and patient incentives are crucial for shortening study duration and ensuring adequacy of sample sizes for successful research in pregnancy. National health service structures, such as those found in Europe and Canada, makes multicenter collaboration for prospective studies more feasible than for countries such as the USA, in which the fees-for-service system is used. Utilization of telemedicine and handheld ultrasound systems and participation in prospective multicenter registries could not only improve the clinical care of pregnant women in underdeveloped countries, but also provide a platform for research during pregnancy. Multicenter and even global registries supported by European cardiac societies have been formed recently that are beginning to bring forth much-needed data regarding pathological states, such as peripartum cardiomyopathy and pregnancy in congenital heart disease. Such studies are largely confined to non-US countries and have started seeing participation from underdeveloped countries. Studies on pregnancy in connective tissue disorders, older women, post-chemoradiation therapy or organ transplantation and in the HIV state remain limited.

Variation in outcomes in trials reporting effects of diet and lifestyle based intervention on pregnancy outcomes: a systematic review.

Obesity is a growing threat to women of childbearing age. Increased maternal weight or excessive weight gain in pregnancy is associated with adverse pregnancy outcomes. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on a number of clinical outcomes. There is no consensus amongst the trialists on the core outcomes that need to be reported to inform the clinical care of pregnant women. The aim of this systematic review is to evaluate variation in the type and quality of outcomes reported in systematic reviews and randomised controlled trials on diet and lifestyle interventions on maternal and fetal outcomes. We will assess the correlation between the type of outcome, the quality of the studies and journal impact factor. We searched the major databases from the inception to October 2013 without language restrictions. We used current recommendations for quality of outcome reporting using a 6-point scale. The quality assessment of systematic reviews and RCTs was performed using the AMSTAR and Jadad scoring systems. Additionally we obtained journals' impact factor in the year of publication. We calculated Spearman rank coefficient to assess the correlation between the type of outcome, and study quality. An overview of outcome reporting will show the current attitude of the researchers towards outcomes of importance when conducting trials on diet and lifestyle management in pregnancy. If our abstract is accepted, we will provide the details of the results.

Drug labeling in the practice of obstetric anesthesia

This commentary outlines the current drug labeling practices that potentially compromise the clinical care of pregnant women and their children. We highlight the need for drug manufacturers and lawmakers to change the status quo and consider practices and regulations that will provide much-needed guidance to clinicians on the safe administration of drugs to certain populations such as pregnant and nursing women. Current practices have de facto contributed to a situation in which evidence is inadequate for individual physicians and patients to weigh the risks and benefits of drug administration and make informed decisions for drug use during pregnancy and lactation.

Obstetric Nephrology

This review highlights factors of importance for the clinical care of pregnant women with pregestational diabetes and microalbuminuria or diabetic nephropathy with particular focus on the role of intensive antihypertensive treatment during pregnancy. Most information in the literature comes from women with type 1 diabetes and diabetic nephropathy, but this is probably also valid for women with type 2 diabetes. Careful counseling of women with diabetic nephropathy before pregnancy with estimation of the risk for the mother and fetus is important. Pregnancy does not result in worsening of kidney function in women with diabetic nephropathy and normal serum creatinine, but pregnancy complications such as pre-eclampsia and preterm delivery are common. Intensive metabolic control before and during pregnancy, low-dose aspirin from 12 gestational weeks onward, and intensive antihypertensive treatment are important. Methyldopa, labetalol, and nifedipine are regarded safe in pregnancy, whereas angiotensin converting enzyme inhibitors, AngII antagonists, or statins should be paused before pregnancy. Case series and pathophysiological studies support the use of a stringent goal for BP and albumin excretion in pregnant women with diabetic nephropathy. Screening for diabetic retinopathy before and during pregnancy is mandatory and laser treatment should be performed if indicated. Pregnancy outcome in women with diabetic nephropathy has improved considerably with a take-home-baby rate of approximately 95%. Further research on the benefits and risks of intensive antihypertensive treatment in this population is needed.

Corrections to: Clinical Care of Pregnant Women with Epilepsy: Neural Tube Defects and Folic Acid Supplementation

Corrections to: Clinical Care of Pregnant Women with Epilepsy: Neural Tube Defects and Folic Acid Supplementation

Clinical Care of Pregnant Women with Epilepsy: Neural Tube Defects and Folic Acid Supplementation

Women with epilepsy (WWE) have a risk of bearing children with congenital malformations that is approximately twice that of the general population. Most antiepileptic drugs (AEDs) have been associated with such risk. Valproate and carbamazepine have been associated specifically with the development of neural tube defects (NTDs), especially spina bifida. Other factors may contribute to the risk, including concomitant diseases such as diabetes mellitus, occupational exposure to teratogens, excessive prepregnancy weight, and various nutrient deficiencies. In the general population, maternal folate deficiency, in particular, has been linked with the development of NTDs, and periconceptional folate supplementation with a reduction of risk. It is unclear whether folate supplementation has a comparable protective effect for WWE. Data concerning the risk for congenital malformations associated with the newer AEDs (gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, and zonisamide) are still limited. Several pregnancy registries for women taking AEDs have been established. Comprehensive postmarketing surveillance, regionally or nationally, might be the ideal method of monitoring medication safety, but government support for such an undertaking has for the most part been lacking. Despite uncertainty about the efficacy of periconceptional folate supplementation in WWE, these women should receive such supplementation at dosage levels recommended for the general population of women of childbearing age. Seizure control must not be neglected in a pregnant woman with epilepsy since seizures are associated with harm to the fetus as well as the mother. Risk may be minimized by using a single AED at the lowest effective dosage.