Alternate Birth Strategies.

Community birth is defined as birth that occurs outside the hospital setting. Birthing in a birth center can be safe for certain patient populations. Home birth can also be safe in well-selected patient with a well-established transfer infrastructure should an emergency occur. Unfortunately, many areas of the United States and the world do not have this infrastructure, limiting access to safe community birth. Immersion during labor has been associated with decreased need for epidural and pain medication. Delivery should not occur in water due to concerns for infection and cord avulsion. Umbilical cord non-severance (also called lotus birth) and placentophagy should be counseled against due to well-documented risks without clear benefit. Birth plans and options should be regularly discussed during pregnancy visits.

Birth plans: definitions, content, effects, and best practices.

The first written guide for birth plans was introduced in 1980 as a means for birthing people to document their choices in the child birthing experience. The birth plan offers an opportunity for the patient and the provider to discuss the birthing process and determine how to safely accommodate patient preferences. Patient satisfaction with birthing plans is variable and may depend on how many requests they have, how many of their plans are accomplished, route of delivery, and whether complications arise during or after delivery. Unmet expectations may lead to posttraumatic stress disorder, but following a birth plan may also be protective against it. Birthing people who use a birth plan may be less likely to use epidural anesthesia, have early amniotomy, or use oxytocin. The first stage of labor may be longer when a birth plan is used; however, there does not seem to be a decrease in the length of the second stage of labor among patients with a birth plan. Some providers believe that a disadvantage of birth plans is disappointment when birth plans are not able to be followed, and others consider that birth plans interfere with professional autonomy.

Are the Diagnosis and Treatment of Acute Cystitis in the Premenopausal, Pregnant, and Postmenopausal Women the Same? A Review of the Literature.

Importance: Acute cystitis is a common condition diagnosed in women. The diagnosis and treatment of this condition change throughout a woman's life. Understanding the differences in diagnosis and treatment in premenopausal, pregnant, and postmenopausal woman increases the likelihood of treatment success and decreases risk of complications from untreated or suboptimally treated infections. Objective: The aim of this review is to describe the incidence, risk factor, pathophysiology, diagnosis, and management of acute cystitis and the similarities and differences of these aspects of the condition in the premenopausal, pregnant, and postmenopausal woman. Evidence Acquisition: A PubMed, Web of Science, and CINAHL search was undertaken with the years 1990 to 2020 searched. Results: There were 393 articles identified, with 103 being the basis of review. Multiple risk factors for acute cystitis have been identified and are largely consistent throughout a woman's lifetime with few exceptions. The diagnoses by group with common diagnostic tools, such as urinalysis, vary in specificity and sensitivity between these groups. Management also varies between groups, with pregnancy having specific limitations related to drug safety in regard to possible fetal effects posed by certain medications commonly used to treat acute cystitis. Conclusions: Acute cystitis not only varies in presentation throughout a woman's lifespan, but also in appropriate diagnosis and treatment. Treatment of acute cystitis does have some commonalities between the groups; however, there are contraindications unique to each group. These differences are paramount to not only ensuring appropriate treatment but also treatment success. Relevance: Acute cystitis is a common condition with different diagnostic and management recommendations throughout a woman's lifespan.

Is a Surrogate Pregnancy a High-Risk Pregnancy?

IMPORTANCE: As assisted reproductive technology has advanced, there has been an increase in gestational carriers/surrogate pregnancies. Information is needed to determine if these pregnancies are high-risk pregnancies and should be managed by maternal fetal medicine or if they are not high risk and should be cared for by residency-trained obstetricians and gynecologists. OBJECTIVE: In this review of the literature, we explore whether surrogate pregnancies should be classified as high-risk pregnancies and managed by subspecialists. EVIDENCE ACQUISITION, RESULTS: Our literature search discovered 28 relevant studies that evaluated surrogate pregnancy and pregnancy complications/outcomes. We learned that the overall risk by using artificial reproductive technology and risks for hypertension, preterm delivery, cesarean delivery, low birth weight neonate, fetal anomalies, and stillbirth did not seem to increase maternal/perinatal risk to the level where a subspecialist was required for the inclusive management of a gestational surrogate. Given that the ideal gestational carrier is healthy, has previously had a term pregnancy, has a single embryo implanted, and has had no more than 3 prior cesarean deliveries, these pregnancies should be lower-risk pregnancies. CONCLUSIONS: We recommend that close monitoring and high index of suspicion should be maintained for complications, but care for the surrogate pregnancy can be accomplished by a residency-trained obstetrician-gynecologist. RELEVANCE: An uncomplicated surrogate pregnancy can be managed by a residency-trained obstetrician-gynecologist and does not need to be managed by high-risk obstetric subspecialists.

Surrogacy and Pregnancy.

IMPORTANCE: Surrogacy allows for parenthood when it is otherwise impossible or exceedingly difficult; however, the risks of surrogate pregnancy for the gestational surrogate and the fetus are not well defined. OBJECTIVE: The aim of this study was to review the literature to examine the prevalence and requirements of surrogate pregnancy and maternal and perinatal outcomes. EVIDENCE ACQUISITION: A CINAHL and 2 PubMed searches were undertaken using the terms "surrogate mothers" OR "(surrogate or surrogacy)" AND "(mothers OR pregnancy OR pregnant)." The second search used these terms and pregnancy outcomes. The search was limited to the English language, but the years searched were unlimited. RESULTS: The search identified 153 articles, 36 of which are the basis for this review. The number of surrogate pregnancies is increasing in the United States. Fetal risks associated with surrogacy include low birth weight, increased risk of multiple gestation, and preterm birth. Maternal complications associated with surrogate pregnancy include hypertensive disorders of pregnancy, postpartum hemorrhage, and gestational diabetes. CONCLUSIONS AND RELEVANCE: Surrogacy is a route to parenting that is not without risk to the surrogate or the fetus, and surrogate pregnancy is increasing in frequency in the United States.

The Use of Electronic Cigarettes in Pregnancy: A Review of the Literature.

IMPORTANCE: Electronic cigarette (e-cigarette) use in pregnancy has been steadily increasing and has been hyped as being a safe alternative to cigarette smoking during pregnancy. This review discloses what is currently known about e-cigarette use in pregnancy and the effects of its use on pregnancy outcomes. OBJECTIVE: To determine what is currently known about the prevalence of e-cigarette use in pregnancy and the effects of e-cigarette use on pregnancy and perinatal/neonatal outcomes. EVIDENCE ACQUISITION: A PubMed, CINAHL, and EMBASE search was undertaken using the search terms "pregnancy" OR "pregnancy complications" OR "pregnancy outcome" OR "newborn" OR "neonate" OR "birth" AND "electronic cigarettes" OR "e-cigarettes" OR "ecigarettes" OR "vaping" OR "vape." The search was limited to the English language and between 2007 and October 12, 2017. RESULTS: The search identified 91 articles, 40 of which are the basis for this review. The prevalence of e-cigarette use is 0.6% to 15%. The amount of nicotine consumed by e-cigarette users is comparable to that consumed by cigarette smokers. Most of the animal model studies suggest a potential danger to the developing fetus primarily because of the nicotine consumed and that consumption has multiple effects on the immune system, neural development, lung function, and cardiac function. There is a widespread flawed perception that e-cigarettes are safe to use during pregnancy. CONCLUSIONS: The marketing of e-cigarette use as a safer alternative to cigarette smoking has led to an increasing use even in pregnancy. The nicotine consumed by e-cigarettes is similar to that consumed by cigarette smoking. Animal studies confirm the dangers of nicotine to the developing fetus. More research needs to be done specifically assessing e-cigarette use, pregnancy, and pregnancy outcomes. RELEVANCE: The amount of nicotine consumed in cigarette smoking is similar to the amount of nicotine consumed with e-cigarettes. The effects of nicotine exposure during fetal development are well known and include effects on multiple organ systems.

A phase I dose-escalation clinical trial of a peptide-based human papillomavirus therapeutic vaccine with Candida skin test reagent as a novel vaccine adjuvant for treating women with biopsy-proven cervical intraepithelial neoplasia 2/3.

PURPOSE: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. PATIENTS AND METHODS: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 µg per peptide). RESULTS: The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 µg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations (P = 0.02). CONCLUSION: This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that Candida, which induces interleukin-12 (IL-12) in vitro, may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.

Birth statistics of high birth weight infants (macrosomia) in Arkansas.

The incidence of macrosomia in Arkansas was relatively unchanged from 2004 to 2010 with the incidence being 7.7%. Some risk factors identified through the analysis of hospital discharge data include male fetus, gestational age, maternal weight gain during pregnancy, and pregestational and gestational diabetes.

Estimate of fetal weight by ultrasound within two weeks of delivery in the detection of fetal macrosomia.

BACKGROUND: Delivery of a macrosomic fetus can be linked with significant maternal and perinatal morbidity. Detection of the macrosomic fetus prior to delivery could have a significant impact on reducing that morbidity. AIMS: The purpose of this study was to determine the likelihood of detection of macrosomia at the time of labour and delivery admission using ultrasound. METHODS: Retrospective review using the electronic medical record and delivery room logs to identify women admitted to labour and delivery with a birthweight of ≥4000 g. RESULTS: There were 272 macrosomic neonates delivered between January 2010 and December 2012, of which, 91 (33.46%) were identified as macrosomic by ultrasound. Using Spearman correlation, the association between the estimated fetal weight by ultrasound and birthweight was r = 0.214 (95% CI: 0.098-0.325; P = 0.0004). In bivariate analyses, only White race was significant for macrosomia detection with 59 of 149 (39.6%) identified compared with 32 of 123 (26.02%) (P = 0.020) non-White people. In the multivariate model, race remained significant. The odds of being labelled macrosomia for White people was 2.051 (95% CI: 1.188-3.542) compared with non-White people (P = 0.010). CONCLUSIONS: Only 33% of fetuses whose birthweight was ≥4000 g were identified by a labour and delivery ultrasound. White race was the only significant factor that increased the odds of having a correct diagnosis of macrosomia by ultrasound.

Vulvodynia in Arkansas: a survey of Arkansas gynecologists' practice experience and management of vulvar pain.

The objective of this survey was to determine the level of experience OB/GYN (Obstetrics & Gynecology) physicians in the state of Arkansas have in seeing and managing patients with vulvar pain, commonly known as vulvodynia. The 8 question, anonymous survey was mailed to Arkansas OB/GYN physicians. The survey assessed the experience of the providers, the age range of their patients, and whether or not they treat and/or refer. Thirty of 182 surveys were returned for a rate of 16.4%. The survey revealed that physicians are moderately comfortable treating vulvodynia within their practice and refer mostly for treatment failure.

Safe composition levels of transgenic crops assessed via a clinical medicine model.

Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. In the case of a food and feed crop, no single variety is considered the standard for safety or nutrition, so the substantial equivalence of transgenic crops is investigated relative to the array of commercial crop varieties with a history of safe consumption. Although used extensively in clinical medicine to compare new generic drugs with brand-name drugs, equivalence limits are shown to be a poor model for comparing transgenic crops with an array of reference crop varieties. We suggest an alternate model, also analogous to that used in clinical medicine, where reference intervals are constructed for a healthy heterogeneous population. Specifically, we advocate the use of distribution-free tolerance intervals calculated across a large amount of publicly available compositional data such as is found in the International Life Sciences Institute Crop Composition Database.

Compositional safety of event DAS-40278-9 (AAD-1) herbicide-tolerant maize.

Event DAS-40278-9 maize expresses the aryloxyalkanoate dioxygenase-1 enzyme, which was originally identified in the soil bacterium Sphingobium herbicidovorans. This enzyme degrades 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate herbicides (e.g., haloxyfop, cyhalofop, quizalofop, etc.); therefore, plants that contain this enzyme are tolerant to these herbicides. We employed the substantial equivalence approach to investigate the compositional safety of event DAS-40278-9 maize. A total of 82 different compositional analyses were conducted to evaluate the equivalence of event DAS-40278-9 and conventional maize. Analyte levels within the transgenic entries were either within literature ranges for non-transgenic maize or statistically indistinguishable from the non-transgenic near-isogenic hybrid, thus indicating substantial equivalence between event DAS-40278-9 and its conventional counterpart. These results agree with dozens of published studies for other transgenic events where input traits were found to have a negligible effect on crop composition compared with traditional breeding methods.

Compositional assessment of event DAS-59122-7 maize using substantial equivalence.

Event DAS-59122-7 (Herculex RW) maize (Zea mays L.) plants were transformed to express the Cry34Ab1 and Cry35Ab1 binary insecticidal crystal proteins originally isolated from Bacillus thuringiensis Berliner (Bt) strain PS149B1. These proteins protect maize roots from attack by corn rootworms, Diabrotica spp. DAS-59122-7 maize also contains the pat gene, originally isolated from Streptomyces viridochromogenes, which confers tolerance to glufosinate-ammonium herbicides (e.g. Liberty). We assessed the composition of these transgenic plants (with and without Liberty herbicide treatment), grown at a total of eight fields sites over 2 years, by applying the principle of substantial equivalence. Forage and grain samples were analyzed for proximates, fiber and minerals, and grain was further analyzed for amino acids, fatty acids, vitamins, secondary metabolites and anti-nutrients. Data plots were prepared that allow for efficient investigation of equivalency between event DAS-59122-7 maize and a non-transgenic near-isogenic maize line grown contemporaneously. Results demonstrated that DAS-59122-7 maize is equivalent to non-transgenic maize with respect to these important constituents.

Compositional equivalency of Cry1F corn event TC6275 and conventional corn (Zea mays L.).

Maize (Zea mays L.) plants have been transformed to express a Cry1F insecticidal crystal protein originally isolated from Bacillus thuringiensis Berliner. This protein controls lepidopteran pests of maize, including the European corn borer, Ostrinia nubilalis (Hübner). As part of the safety assessment for crops containing transgenes, a compositional analysis of the food and feed is conducted. This analysis is designed to detect unintended changes in the nutrient and antinutrient content of the raw commodities produced by the crop due to the insertion of the genes into the genomic DNA of the plant (pleotropic effects). Samples of transgenic and nontransgenic maize forage and grain were collected from six field sites located in the U.S. and Canada. Forage samples were analyzed for proximates and minerals, and grain was further analyzed for fatty acids, amino acids, vitamins, secondary metabolites, and antinutrients. Results demonstrated that maize expressing the Cry1F protein was equivalent to nontransgenic maize with respect to these important components. Comparison of the variability within the nontransgenic and transgenic hybrid, as compared to composition values reported in the literature, suggest that factors other than transgenes may contribute more substantially to the composition of crops.