Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Validation and Clinical Use of the Non-Invasive Prenatal Test “Veracity”

Introduction

Cell-free DNA has been utilized as a novel analyse for the development of non-invasive approaches to prenatal genetic testing using different methodologies [1-4]. Following the publication of a number of major research and clinical studies that revealed high accuracy to detect fetal aneuploidies, the use of noninvasive prenatal testing (NIPT) has been widely adopted in clinical practice. NIPT technologies provide significant improvements over conventional invasive prenatal testing and consequently, international bodies endorse NIPT as a routine screening option [5,6]. This has resulted in many institutions adopting NIPT within the scope of standard of care for autosomal and sex chromosomal aneuploidy detection (SCA). Mother and Child Clinic is a primary clinical centre certified by the Russian Ministry of Health and specialises in screening and diagnosing prenatal chromosomal aneuploidies. NIPT has been offered as a prenatal screening option in our clinic since (May 2017). This study aims to summarize the NIPT results and clinical performance of NIPT in the detection of trisomy 13,18,21 and SCAs using the Veracity non-invasive prenatal test in a cohort of 1382 samples among mixed-risk participants. In this report we convey a complete and robust clinical picture of the performance of Veracity under routine NIPT testing conditions and describe examples of unique clinical cases.

Materials and Methods

Patient cohort

This study included 1382 pregnant women between the ages 18-52 between 9-28 gestational weeks who visited Mother and Child Clinic from May 2017 until October 2018. Of these women 1325 were singleton pregnancies, 37 were twin pregnancies, 20 were vanished twin pregnancies and 169 conceived by in-vitro fertilization including 65 with the use of egg donation. Testing options included detection of trisomy 13,18,21 and optional detection of Sex chromosome aneuploidies (SCAs) and fetal sex. The panel offered for SCAs includes 45X, XXX, XXY, XXYY and XYY constitution. Women provided informed consent and maternal blood (20ml) collected in BCT StreckTubes (Streck, Inc, Omaha, NE) and was sent via courier for testing at the CAP accredited, CLIA certified laboratory of NIPD Genetics Public company Ltd. Sample demographics and outcome information was provided by the clinician and was compiled and reviewed to determine the characteristics of this patient population, as well as estimate the assay performance in our clinical setting.

Pre-test and post-test counselling

Patients were provided with a careful and detailed counselling regarding the benefits, risks and limitations of NIPT testing and provided the relevant consent form. NIPT analysis was conducted immediately for each sample and results were delivered using an electronic web-system within 7 days from sample receipt at NIPD Genetics (Nicosia, Cyprus). Women with a positive NIPT were provided the option of invasive testing. Post-test counselling was given to all participants on the basis of their test results.

Invasive testing

For invasive testing chorionic villus sampling (CVS) or amniocentesis was performed. Comparative genomic hybridization (aCGH) analysis was performed using a customized 60K CGX Chip v2 (Perkin Elmer by Agilent Technologies, Inc, Finland) and the data were analysed by a Genoglyphix aCGH software (PerkinElmer, Finland). Banding cytogenetic was performed using routine techniques on G-banded metaphase chromosomes of CVS or cultured amniotic fluid cells. Centromeric probes were used for FISH analysis. Karyotypes were interpreted according to ISCN.

Results

The median gestational age of this patient cohort (n=1382) was 12+3 weeks (Table 1), and the median maternal age was 34.4 (IQR 7.2) years. The median weight was 61 kg (IQR) (Table 1). The overall distributions of gestational weeks and maternal age are depicted in Figure 1 and Figure 2 respectively. In this cohort twin pregnancy samples represented 2.68% of all referrals (Table 1). In this cohort of 1382 cases, 246 cases requested detection of trisomy’s 13,18 and 21, 47 cases requested detection of trisomy’s 13,18,21 and fetal sex and 1089 cases requested the detection of trisomy’s 13,18,21, fetal sex and SCAs. The detection of SCAs was not an available option in twin pregnancies. In this cohort, 1325 cases were singleton pregnancies, 37 were twin pregnancies and 20 were vanished twin pregnancies. The cohort included 169 pregnancies conceived by in-vitro fertilization out of which 65 were performed with the use of egg donation. In the cohort of twin pregnancies, 23 were dichorionic and 14 were monochorionic. The median fetal fraction of reported samples was 10.2% (Figure 3). The fetal fraction increased as gestational weeks increased and exhibited a weak positive correlation (r= 0.19) (Figure 4).

For More Open Access Journals in Iris Publishers Please click on:

https://irispublishers.com/

For More Articles in World Journal of Gynecology & Womens Health

https://irispublishers.com/wjgwh/

For More Information: https://irispublishers.com/wjgwh/fulltext/validation-and-clinical-use.ID.000573.php

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Gestational Weight Gain and Large for Gestational Age Neonates in a Predominantly Hispanic Population Community Hospital

Abstract

To analyse changes in Gestational Weight Gain (GWG) in different Body Mass Index (BMI) categories at start of pregnancy and neonatal birth weight outcomes in a predominantly Hispanic population living in a low-income environment.

We conducted a cross sectional study of women with singleton gestation who delivered at Wyckoff Heights Medical Centre from January 1st to December 31st, 2017. BMI was categorized at first prenatal visit as normal weight (BMI= 18.5-24.9), overweight (BMI= 25-29.9) and obese (BMI >30). BMI was collected at 16-20, 24-28, and 36-38 weeks of gestation. Stratified by BMI, appropriate GWG were 25–35 pounds for normal weight (27.9%), 15–25 pounds for overweight (34.5%), and 11–20 pounds for obese (24.5%). Neonatal birth weight was categorized by Duryea percentiles and gestational age in weeks. From 831 women, normal weight (n=269), overweight (n=263), and obese (n=299) women were found. GWG was categorized as: inadequate, appropriate, or excessive based on the Institute of Medicine guidelines. The prevalence of excessive GWG was 23.1% for normal weight, 35.8% for overweight, and 37.5% for obese women. The prevalence of inadequate GWG was 48.9% for normal weight, 31.0% for overweight, and 40.6% for obese women. A significant association was found between obese women and >90 percentile neonatal birth weight (OR:2.3, 95% CI: 1.15-4.97). Obese women were more likely to have excessive GWG which is associated with maternal and neonatal adverse outcomes such as NICU admissions, gestational diabetes, hypertensive disorders in pregnancy, delivery by caesarean section, large for gestational age, and shoulder dystocia.

Keywords: Gestational weight gain; Maternal obesity; Pregnancy weight gain; Pregnancy complications

Introduction

Gestational weight gain (GWG) is the amount of weight one gains throughout the pregnancy. This weight gain can be influenced by many factors including: age, socioeconomic factors, ethnicity, and maternal comorbidities, such as pre-gestational obesity [1-4]. Excessive gestational weight can lead to numerous adverse maternal and neonatal events such as the development of gestational diabetes, gestational hypertension, and preeclampsia, delivery via caesarean section, macrosomia, neonatal hypoglycaemia and shoulder dystocia. Due to the complications that can arise, recommendations were set forth by The Institute of Medicine (IOM) designating the appropriate amount of weight women should gain based on her pre-pregnancy BMI [5]. Although these guidelines were set forth just eleven years ago in 2009, they are debatable and do not take into consideration various important factors such as: weight gain among different ethnic groups, those of low socioeconomic status and/or those with a lower education level [5].

In the United States, more than 40% of pregnant women exceed the Institute of Medicines guidelines [6]. Excessive gestational weight gain varies by ethnicity and socioeconomic status with low income populations and non-whites being at the greatest risk [1].

Hispanics are the largest minority group living in the United States. They have the highest rates of inadequate and excessive GWG and are the group with the highest birth rate [6]. Hispanic women, specifically those from the Caribbean, experience the greatest health disparity. Furthermore, this subgroup of women has the highest prevalence of maternal comorbidities including obesity and type 2 diabetes mellitus and exhibit adverse outcomes associated with poor nutrition [6].

Women who are classified as severely obese at conception have an increased risk of infant mortality, stillbirth, congenital malformations, large for gestation infants, hypertensive disorders of pregnancy, gestational diabetes, prolonged second stage of delivery, delivery via caesarean section and maternal mortality than non-obese women [7].

In our predominantly Hispanic population, we sought to determine whether the pattern of maternal gestational weight gain was associated with clinically significant changes in the neonatal birth weight.

Materials and Methods

Design and settings

We performed a single‐centre, retrospective study of patients enrolled in the prenatal service and delivered at Wyckoff Heights Medical Centre in Brooklyn, New York. The hospital is located in a community comprised of primarily Latinos living below the poverty line [8]. We enrolled women who received prenatal care and delivered a live born singleton gestation presenting to the obstetrics and gynaecology department between January 1st to December 31st, 2017 and delivered a singleton infant. This study was approved by our Institutional Review Board at Wyckoff Heights Medical Centre.

Study population

We enrolled a sample of adult women, 18 years or older, who received prenatal care and delivered at Wyckoff Heights Medical Centre. One thousand three hundred fifty-six charts were reviewed and eight hundred forty-five women met the inclusion criteria. Fourteen women who were classified as underweight at the initial prenatal visit were excluded due to inadequate sample size.

Data collection and data management

Baseline demographic data were collected on all enrolled women and neonates (Table 1). Maternal data such as maternal age at delivery, height, body weight at: first prenatal visit, 16-20 weeks’ gestation, 24-28 weeks’ gestation, 36-38 weeks’ gestation, as well as reproductive characteristics such as gravidity, parity, mode of delivery, past medical history and blood which were extracted from the hospital medical record. Neonatal data including gestational age at delivery, birth weight, and neonatal intensive care unit admission (Figure 2) as well as length of stay were collected from the hospital medical record.

For More Open Access Journals in Iris Publishers Please click on:
https://irispublishers.com/
 
For More Articles in World Journal of Gynecology & Womens Health
https://irispublishers.com/wjgwh/

For More Information: https://irispublishers.com/wjgwh/fulltext/gestational-weight-gain.ID.000572.php

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Pregnancy Treatment in Covid-19 Pandemic: General Considerations

Editorial

The recent COVID-19 pandemic turned the obstetric scientific community on alert, since the information available during pregnancy is still limited [1]. Chinese data seems to demonstrate that symptoms during pregnancy would be similar to those of general population - fever, cough, dyspnoea, and asthenia. It is important to note that most of time; the symptoms (when present) will be mild and similar to “flu” [2].

The severity of cases is linked to serious respiratory impairment, once pregnant women have decreased residual pulmonary capacity, with a dropping “reserve” and increased rate of oxygen consumption, which generates tendency to hypoxia [2].

In fact, there is no specific treatment for COVID-19. Proposed treatments are being analysed over the days. The main action is clinical support during pregnancy. Antibiotics are indicated in cases when secondary bacterial infection involvement is suspected or confirmed, or even when it cannot be ruled out.

Antibiotic protocols proposed for treating pneumonia in pregnancy classically include the use of beta lactams (3rd generation cephalosporin) with association of a macrolide (clarithromycin or azithromycin). This can be scaled according to the patient’s clinical situation and antibiogram [3]. The use of Oseltamivir 75mg is also indicated for all cases of flu syndrome in all risk populations, such as pregnant women [3].

Hydroxychloroquine is an approved medication for malaria treatment and rheumatological disorders and is also approved in pregnancy. Initial studies have shown a possible action of this medication against COVID-19, but its use is being classified by societies of infectious diseases as “experimental rescue”, therefore, must be restricted to critically ill patients within clinical protocols approved by ethics committees. Its routine or prophylactic use in just confirmed cases is not recommended [4-6].

Fluids infusion is an integral part of treatment for sepsis, especially when hypotension (systolic blood pressure <90) or hypo perfusion is present. The Sepse Surviving Campaign recommends an initial bolus of 30ml/Kg, which in pregnancy can be “too much” because of the reduction in colloid osmotic pressure and the tendency to leak into the third space, worsening ventilator parameters. It seems reasonable to infuse 1-2 litres of crystalloid solution in septic and hypotensive pregnant women. In addition, only half of septic patients are “fluid responders” - justifying conservative fluid management [7].

If patient remains hypotensive (medium arterial pressure less than 60mmHg) despite volume resuscitation, the use of vasopressors is indicated. In pregnancy, noradrenaline is the vasopressor of choice and its use should not be delayed [7].

Fetal gas exchange depends on two variables - maternal PaO2/PaCO2 and utero-placental flow. Our efforts should focus on maintaining a maternal PaO2> 70mmHg, which would be equivalent to a saturation ≥ 95% and sufficient for adequate fetal oxygenation. The gasometry of a pregnant woman usually presents changes secondary to the increase in tidal volume - pH 7.40-7.47 (tendency to respiratory alkalosis) due to a drop in maternal PCO2 around 30mmHg. The drop in maternal PCO2 and the maintenance of placental uterine flow are the main responsible for fetal CO2 clearance [7].

The concept of fetal viability is the gestational age which the new-born has more than 50% chance of survival and at least 50% of the survivors present no severe long-term squeal. Below fetal viability (24 to 26 weeks) only fetal beats auscultation may suffice. After this period, more detailed evaluation using ultrasound and Doppler is desirable, with frequency of revaluation depending on fetal maternal condition [8].

COVID 19 infection is not an isolated indication for early delivery. Delivery may be necessary in those patients with progressive clinical worsening. The route must follow obstetric indications, since there is no evidence until this moment of caesarean section benefit in women with COVID infection19. This may be necessary in critically ill patients, especially those on mechanical ventilation [2]. Between 24 - 26 weeks to 34 weeks, if delivery is necessary, consider the possibility of corticotherapy and magnesium sulphate infusion for fetal neuroprotection [2].

For More Open Access Journals in Iris Publishers Please click on:
https://irispublishers.com/
 
For More Articles in World Journal of Gynecology & Womens Health
https://irispublishers.com/wjgwh/

For More Information: https://irispublishers.com/wjgwh/fulltext/pregnancy-treatment-in-covid-19.ID.000571.php