Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Combination Local Therapy of Genitourinary Menopausal Syndrome Symptoms

Abstract

Introduction: Genitourinary syndrome of menopause (GSM) is a pressing gynecological problem since the condition leads to the deterioration in the quality of life of postmenopausal women.

Objective: compare the efficacy of relief of GSM with intravaginal use of estriol monoproduct and a combination product containing estriol, micronized progesterone and Lactobacillus casei rhamnosus Doderleini.

Materials and Methods: the study enrolled 69 postmenopausal women aged 53.6±2.1 diagnosed with postmenopausal atrophic vaginitis. After screening, the patients were randomized into 2 groups: Group 1 (n=34) used 0.5 mg/day of estriol monoproduct intravaginal for 14 days, followed by a gradual dose reduction based on symptom relief until a maintenance dose was reached (i.e. 1 suppository 2 times a week), Group 2 (n=35) used intravaginal combination product in the form of capsules containing 0.2 mg of estriol, 2.0 mg of micronized progesterone and lyophilized culture of L. casei rhamnosus Doderleini – 341mg (2*107 CFU) (Trioginal, Besins Healthcare SA, Belgium). The product was prescribed to be taken at a dose of 2 capsules intravaginal 1 time/day for 20 days, then 1 capsule/day. Total duration of therapy in both groups was 12 weeks. After the end of therapy, patients were monitored for 12 weeks. To determine the efficacy of the treatment, subjective and objective clinical symptoms of GSM were evaluated using the adapted Nappi RE scale at the study visits. 5-point D. Barlow scale, vaginal pH, Bachmann’s Vaginal Health Index was additionally used. The main software for statistical analysis was the IBM SPSS 22 statistical package.

Results: After 12 weeks of treatment, complaints of dyspareunia resolved completely in 18 (52.9%) patients in Group 1 and 25 (71.5%) in Group 2, p<0.05; 12 weeks after the end of therapy: in 24 (70.6%) patients in Group 1 and in 34 (97.1%) patients in Group 2, p<0.05. Improvement in elasticity after 12 weeks of therapy was observed in 19 (55.9%) and 27 (77.1%) patients of Group 1 and Group 2, respectively (p<0.05); normal epithelial thickness was observed in 26 (76.5%) and 30 (85.7%) patients, respectively (p<0.05). 12 weeks after the end of treatment in Group 1 and Group 2, improvement in elasticity was observed in 22 (64.7%) and 30 (85.7%) patients; normal epithelial thickness was observed in 22 (64.7%) and 27 (77.1%) patients, respectively (p<0.05). For the rest of analysed parameters (D. Barlow scale, pH, Bachmann’s Vaginal Health Index) statistical analysis did not reveal any statistically significant differences between the groups in the dynamics of treatment and follow-up.

Conclusion: Thus, local combination hormone therapy with probiotic support can be an effective treatment option for genitourinary syndrome of menopause since it helps to enhance proliferative processes, improve blood circulation, restore biocenosis and relieve symptoms of coital pain. Compared with local estriol monotherapy, having a comparable effect on the condition of vaginal epithelium, it is significantly more effective for eliminating the symptoms of sexual dysfunction.

Keywords: Genitourinary syndrome of menopause; Vulvo-vaginal atrophy; Local hormone therapy

Introduction

Due to increasingly aging of the population the problem of relieving symptoms caused by age-related changes in the female uro genital tract during menopause remains one of the most pressing problems of the world gynaecology. The widely used terms “uro genital syndrome”, “atrophic vulvovaginitis”, including the diagnosis “postmenopausal atrophic vaginitis” in ICD-X (N95.2) and similar definitions do not reflect the entire scope of modern ideas about the cause, pathogenesis and clinical presentation of the syndrome.

In 2014, the new term “genitourinary syndrome of menopause” (GSM) was introduced into clinical practice to replace the term “vulvovaginal atrophy”, which was commonly accepted earlier and did not fully reflect the essence of the problem. The term GSM emphasizes the many genital, sexual and urinary symptoms associated with the anatomical and functional changes in the vulvovaginal tissues that occur during aging [1].

According to the modern integrative definition, GSM is a complex of symptoms that includes physiological and anatomical changes that occur secondary not only to estrogen deficiency but also other sex steroids in women in the external genitalia, perineum, vagina, urethra and bladder. The use of the new term by all related specialists who deal with the problem of urogenital disorders in women is of high clinical significance since it allows us to consider the complex effect of all sex steroid hormones on the urogenital region [2-4].

According to modern recommendations for menopausal hormone therapy and maintaining the health of older women, local estrogen therapy is the “gold” standard for the treatment of vulvovaginal atrophy. Moreover, local estrogen therapy in low doses is preferable for women with complaints of vaginal dryness or associated discomfort during sexual activity. Vaginal oestrogens are generally more effective for alleviating urogenital symptoms than oral products due to no liver metabolism and a quick vaginal response [5,6]. The modern polyhormonal concept of the pathogenesis of GSM opens up new potential opportunities for studying ways to optimize its traditional local estrogen therapy by additionally prescribing topical forms of products of other sex hormones, for example, a combination of estriol with progesterone, androgens (DHEA), thus turning the hormonal local monotherapy of GSM into hormonal combination local therapy. As is shown in clinical practice, complex hormonal impact gives better results in a shorter time. After local saturation with estriol and progesterone, vaginal colonization with the necessary lactobacilli becomes more favourable, which is necessary to restore normal vaginal micro flora [7,8].

In Russia, in addition to estriol monoproduct, another product is used for intravaginal use in GSM, which is a combination of estriol with micronized progesterone and lactobacillus casei rhamnosus Doderleini (LCR) in vaginal capsules (Trioginal, Besins Healthcare SA, Belgium). The main advantage of the complex product is micronized progesterone in its content with its effects that are not related to the classical role of sexual reproduction. Oestrogens promote the growth and maturation of the vaginal epithelium, as well as the synthesis and accumulation of glycogen, which is a key substrate for the activity of lactobacilli, which must be in the lumen of the vagina in order to be utilized by lactobacilli. The process of release of glycogen from the vaginal epithelium requires participation of progesterone, which contributes to the formation of intermediate layers of vaginal epithelium and its natural desquamation. A similar situation takes place in the hormone-dependent tract of the lower urinary tract, where oestrogens perform the same critical physiological functions for urothelium, ensuring its growth and maturation, synthesis and accumulation of glycogen, as well as synthesis of local immunity factors (immunoglobulin’s) and protective mucopolysaccharides – glycosaminoglycan’s (hyaluronic acid and its sodium and zinc salts, chondroitin sulphate, glycoproteins, mucin) that make up the surface glycocalyx of the bladder mucosa – a powerful natural system of antibacterial and anti-inflammatory protection of the lower urinary tract [9-11]. However, complete natural antibacterial protection of the urothelium of the urethra and bladder in women is impossible without progesterone, which is related to the fact that oestrogens affect the synthesis of glycosaminoglycan’s in urothelium of the bladder, and progesterone affects their release by urothelium out into the lumen of the bladder [12-13]. Moreover, it is important to emphasize non-reproductive effects of micronized progesterone: analgesic – due to suppression of the synthesis of prostaglandins; neuroprotective and neuroreparative – due to selective effect on the receptors of neurotransmitters; regulatory – due to increased synthesis of muscle protein [14].

Thus, modern literature indicates that in order to ensure normal anatomical and functional state of the lower urinary and genital tracts in women, a sufficient level of both estrogen and progesterone is necessary [15-17]. Disorder of the synthesis and release of glycogen secondary to deficiency of sex hormones leads to rapid alkalization of the vagina and the development of dysbiotic processes – a decrease in the number of lactobacilli and an excessive growth of pathogenic and conditionally pathogenic microorganisms [18]. According to the data of Hillier SL, et al. in a detailed analysis of vaginal micro flora of 73 postmenopausal women who did not receive hormonal therapy, 49% had no lactobacilli at all, while in those who had the concentration was 10-100 times lower than in premenopausal women. According to other studies, lactobacilli predominate in the vaginal microflora only in 13% of postmenopausal women not taking hormonal therapy. In postmenopausal women, the most common microorganisms are anaerobic gram-negative bacilli and gram-positive cocci [19]. Thus, the normalization of vaginal microflora is one of the goals of treatment of GSM. Moreover, recently there has been evidence that normalization of vaginal microflora not only reduces the frequency of relapse of urinary tract infections in women in peri- and postmenopausal women, but also contributes to a more rapid relief of GSM symptoms [20-21]. The goal of lactobacilli in products for the treatment of GSM symptoms is to reduce pH and maintain normal biocenosis, preventing colonization of the vagina by pathogenic bacteria.

The goal of this study was to compare the efficacy of the relief of symptoms of genitourinary syndrome of menopause with intravaginal use of estriol monoproduct and a combination product containing estriol, micronized progesterone and Lactobacillus casei rhamnosus Doderleini.

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Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Ultra Sonographic Mirror Depiction of Enormous Bizarre Intramural Myomas - Laparoscopic Dissection

Abstract

Leiomyomas represent the most common type of benign tumours of the female genital tract. Assiduous preoperative imaging findings reflect proper therapeutic mapping. In cases of female patients of reproductive age, the ultimate goal remains the fertility preservation and the quality of life of the patient.

According to recent bibliography, bizarre leiomyomas remain a controversial issue regarding the preoperative and postoperative therapeutic mapping. Giant cells with pleomorphic nuclei and little or no mitotic activity compose the microscopic analysis of such lesions.

Multidisciplinary approach is mandatory in order to establish ultimate diagnosis and treatment. Bizarre leiomyomas still represent a gray scale among the whole scientific community.

Keywords: Bizarre myomas; Laparoscopic dissection; Mirror depiction

Introduction

Incidence of uterine fibroid tumours increases as women grow older, and they may occur in more than 30% of women 40-60 years of age [1].

Risk factors include null parity, obesity, family history, black race, and hypertension [2]. Uterine fibroids consist of smooth muscular tissue with always the possibility of malignant transformation.

Tumour size and anatomic location are strongly accompanied with assiduous therapeutic strategy. Therapeutic strategy is strongly accompanied with age and fertility capacity of the patient.

In cases of degenerated uterine fibroids in nulliparous patients, laparoscopic approach represents the gold standard of surgical confrontation. Focusing on current bibliography, classification of uterine myomas is mandatory in order to establish proper diagnosis and treatment.

Classification of uterine fibroids consists intramural, subserosal, sub mucosal and intraligamentary (inside parametrial area) [3].

Ultimate goal remains, especially in nulliparous women, extremely conservative approach, protection of fertility preservation and increase patient’s quality of life.

Objective of our study reflects thorough diagnosis and assiduous treatment of clinical symptomatic and ultra-sonographic mirror depiction of two enormous intramural myomas.

Case

We present a case of a 38-year old patient (G0, P0) admitted at our Department, complaining of severe episodes of menorrhagia followed by diffuse abdominal pain.

Analysing her atomic history, she reported reception of thyroxin agents, due to her history of hypothyroidism. Undergoing of cervical cryotherapy due to infiltration of HPV (Human papilloma virus). Transvaginal ultra-sonographic evaluation depicted presence of two enormous intramural myomas maximal diameter around 7cm (Figure 1).

Discussion

Many factors affect the therapeutic mapping of uterine myomas. Age of the patient, gynecologic or obstetrical history, previous surgical procedures and fertility preservation.

Uterine fibroids consist of smooth muscular tissue with always the possibility of malignant transformation [4]. Tumour size and anatomic location are strongly accompanied with assiduous therapeutic strategy [5].

Transvaginal ultrasonography reflects the first preoperative procedure, depending on the physician’s experience and technical sufficiency of the ultrasound machine. Imaging findings as areas of cystic degeneration, enlarged and asymmetric vascularization, papillary protrusions, and possibly increased tumour markers as Ca-125/Ca 15-3/Ca 19-9 reveal preoperative procedures of malignant metaplasia [6].

In such cases, abdominal MRI can, without a doubt, guide the preoperative management [6]. After WHO (World Health Organization) classification bizarre leiomyomas presented as fibroids with giant cells with pleomorphic nuclei and little or no mitotic activity [7].

In many cases they represent a histologic gray zone concerning the therapeutic mapping in female patients of reproductive age. Before final diagnosis is established, assiduous examination of the specimen is mandatory focusing on terms of atypia or necrosis (simple, moderate, or severe).

Along with genetic predisposition and ovarian hormone stimulation, many growth factors are identified. Besides genetic predisposition and ovarian hormones that play a major role in tumour expansion, a large number of growth factors have also been identified which favour expansion.

These are insulin-like growth factor (IGF), epidermal growth factor (EGF) and platelet-derived growth factor (PDGF), transforming growth factor beta (TGF beta), and basic fibroblast growth factor (BFGF) [8]. These may have a role to play in tumour expansion. The major differential dilemma remains the establishment of bizarre uterine myomas versus endometrial stromal sarcoma (ESS).

The main characteristics of ESS consist of infiltrative myometrium growth and vascular invasion, presence of necrotic areas, and mitotic activity [9].

Due to infiltration of the myometrial basal membrane, surgical dissection after staging of the lesion represents the gold standard. Multidisciplinary approach is mandatory in order to establish proper postoperative treatment.

In cases of metastatic ESS, neoadjuvant therapy or series of radiotherapy will under stage the tumour expansion and make the tumour staging surgically feasible. On the other hand, patients with positive progesterone or estrogen receptors (ER+, PR+), can be treated postoperatively with hormonal agents such as progestogens [10].

Conclusion

Bizarre uterine fibroids represent a controversial scientific zone in the current bibliography. More studies must be conducted in order to establish proper diagnosis and treatment. Multidisciplinary approach is mandatory in cases of patients of reproductive age. Ultimate goal remains in such cases, always fertility preservation.

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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).

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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.

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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].

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Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Tranexamic Acid versus Carbetocin for Reduction of Blood Loss during Abdominal Myomectomy: A Randomized Clinical Trial

Abstract

Introduction: Uterine fibroids are benign tumours of the uterus. They represent the most common benign tumour of the female genital tract during reproductive period. The aim of this study was to decrease blood loss during myomectomy using carbetocin in comparison with tranexamic acid.

Material and Methods: In this randomized clinical trial, 132 patients with uterine fibroids were enrolled for our study at Gynaecology outpatient clinic, Suez Canal University Hospitals, from May 2016 to May 2018. Patients were assessed by full history, clinical examination, transvaginal ultrasound and laboratory investigations. After patients’ counselling and consent, they were randomly assigned into 2 groups (66 patients each); the first group received 30 ml of sodium chloride with added 50mg tranexamic acid, while the second group received 30 ml of sodium chloride with added 100 mg Carbetocin. Both drugs were delivered at the time of skin incision by intravenous infusion. The amount of blood loss was estimated intra-operatively and post-operatively and the collected data were statistically analysed.

Results: Total blood loss was significantly lower in the carbetocin group (399.27 ± 28.94ml) than the tranexamic acid group (535.15 ± 80.30ml) (p <0.001). Intra-operative blood loss was significantly lower in the carbetocin group (371.39 ± 27.54 ml) than the tranexamic acid group (478.48 ± 60.4ml) (p <0.001). Post-operative blood loss was significantly lower in the carbetocin group (27.88 ± 32.32 ml) than the tranexamic acid group (56.67 ± 53.13ml) (p 0.001).

Conclusion: Carbetocin is more effective than tranexamic acid on reduction of blood loss during abdominal myomectomy.

Keywords: Fibroids; Myomectomy; Blood loss; Tranexamic acid; Carbetocin

Introduction

Uterine leiomyomas represent the most common benign tumours encountered in women, originating from myometrium smooth muscle cells. These tumours are estrogen dependent and grow during the reproductive period with incidence of approximately 70% in the general population [1]. Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. However, their true prevalence is probably under-estimated [2].

The standard approach for treating leiomyoma is hysterectomy for women who do not want to have more children and myomectomy for those who want to preserve fertility [3]. Bleeding during myomectomy is one of the major complications which can result in significant morbidity and mortality. Despite advances in reducing excessive haemorrhage during the procedure, it still remains a major challenge for gynecologic surgeons [4].

Several interventions have been developed to control bleeding during this operation such as dissection and embolization of uterine artery, use of mechanical tourniquets, use of uterotonic medications such as oxytocin, Carbetocin, ergometrine, misoprostol and manipulation of the coagulation cascade with antifibrinolytic treatment, especially aprotinin, tranexamic acid, epsilonaminocaproic acid, desmopressin and recombinant factor VIIa [5].

Tranexamic acid (TA), a synthetic lysine derivative with antifibrinolytic activity has been used since the 1960s in a variety of clinical settings where anti-fibrinolytic therapy is appropriate. It acts as an anti-fibrinolytic through the reversible blockade of lysine-binding sites on plasminogen molecules. It is an inhibitor of fibrinolysis. It has been routinely used for many years to reduce haemorrhage during and after surgical procedures. It has been shown to be very useful for reducing blood loss and blood transfusions [6].

Carbetocin is a synthetic long-acting oxytocin analogue. Its intravenous half-life is 85 to 100 min which is10 times longer than that of oxytocin. It has a rapid onset and long- lasting action. Carbetocin and uterine oxytocin receptors in the uterus caused rhythmic contraction, which can increase the frequency of existing contractions as well as uterine tone. During surgery, the uterine smooth muscles were made to contract, so that the tumour protrudes from the uterine surface and the level of the tumour cavity would be easy to find and peel [7].

There are no enough studies that compare the efficacy and safety of using intravenous tranexamic acid and intravenous Carbetocin for reduction of blood loss during myomectomy, therefore, this study aims to assess and compare between them for their ability to reduce blood loss during myomectomy.

Materials and Methods

This randomized clinical trial was carried out in the obstetrics and gynaecology department of Suez Canal University Hospital and included 132 female patients with uterine fibroids that necessitated abdominal myomectomy in the period from May 2016 to May 2018.

Inclusion criteria included patients with age ranging from 18 to 50 years with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within last 12 months, patients complaining of abnormal vaginal bleeding, chronic pelvic pain, pressure symptoms or reproductive disorders with pre-operative haemoglobin> 8g/ dl. Exclusion criteria included post-menopausal women together with patients previously treated with Depo-Lupron, Depo- Provera or oral contraceptive pills, patients with known bleeding/ clotting disorders, active liver, kidney or cardiovascular disease or receiving anticoagulant, NSAIDs or antiplatelet, previous history of gynecological malignancy, previous abdominal myomectomy or venous thromboembolism.

After approval to participate in the study by providing informed written consent, patients had been allocated to either group using Simple randomization by a randomization table created by a computer software program. A full history was taken included personal, menstrual, obstetrics, contraceptive, past and surgical histories. All patients had full clinical examination included general, abdominal and vaginal examinations. Laboratory investigations were done including haemoglobin, hematocrit, platelet count, prothrombin time and partial thromboplastin time. An abdominal or transvaginal ultrasound was done to assess the size, number, and location of myomas.

At the time of skin incision, the patients in the first group (n= 66) received 30 ml of sodium chloride with added 500mg tranexamic acid (Kapron 500 mg ampoule, Amoun pharmaceuticals) by intravenous infusion while cases in 2nd group (n=66) received 30 ml of sodium chloride with added 100 mcg Carbetocin (Pabal 100 mcg ampoule, Ferring Pharmaceuticals) also by intravenous infusion. The blood loss was assessed from the start of the operation till skin closure and also post-operative till the second post-operative day or till the removal of the drain. The weight of the dry surgical swabs (30g for each 30*30cm abdominal swabs) was measured before use and after being wet or soaked by blood. A highly accurate digital balance was used to measure the weight in grams. The weight difference was translated into the blood loss considering that 1g is equal to 1ml bl. The amount of intraoperative blood loss (ml) = (the weight of used towels–the weight of towels prior to surgery) + blood in suction apparatus. The amount of postoperative blood loss was assessed by the insertion of intraperitoneal tube drain and the calculation of amount of blood in the drain till the drain removed.

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Iris Publishers_ World Journal of Gynecology & Womens Health (WJGWH)

A Nomogram for Prediction of Risk Factors for Preeclampsia during Antenatal Care at a Tertiary Maternity Hospital

Abstract

Objective: The study aims to create a nomogram for prediction of risk factors for preeclampsia (PE) during antenatal care (ANC) in a tertiary maternity hospital.

Materials and Methods: A cross-sectional study was conducted between May 2016 and December 2017 in a tertiary maternity hospital. Two hundred thirty pregnant women were included, at first visit, personal data, family history of risk factors for PE, maternal medical, and obstetric history was collected. Physical examination, including blood pressure, weight, signs of edema, and urine analysis were done. Then follow up at 24 weeks and after 32 weeks gestation to know if she developed PE or not through the physician. Included nomogram, which was built based on the data of regression analysis, was used to predict the value of one or more responses from a set of predictors.

Results: The study included 230 women. Cases diagnosed with PE during all the follow up are 37 cases (16.1%). Five factors were not significant; maternal age (P=0.154, OR=1.076), consanguinity (P=0.821, OR=1.104), age at marriage (P=0.266, OR=1.404), age at first pregnancy (P=0.319, OR=0.735) and order of pregnancy (3rd or more) (P=0.951, OR=0.984). Only two factors significant; a history of diabetes mellitus (P=0.010, OR=5.923) and history of hypertension (P=0.045, OR=7.838). Probability of PE based on the finding of the nomogram was 68% with good discrimination.

Conclusion: History of diabetes mellitus and hypertension were the predictors in the final model among pregnant women for the development of preeclampsia.

Keywords: Prediction; Preeclampsia; Risk factors; Nomogram

Introduction

Hypertensive disorders of pregnancy are one of the leading causes of maternal and infant morbidity and mortality. Worldwide, hypertensive disorders of pregnancy affect 5-10% of all pregnancies and cause approximately 50,000 deaths among women every year [1]. The incidence of preeclampsia (PE) is influenced by parity, racial, genetic predisposition, and environmental factors may also have a role. The incidence of PE varies greatly worldwide. World Health Organization (WHO) estimates the incidence of PE to be seven times higher in developing countries (2.8% of live births) than in developed countries (0.4%) which is due to poor healthseeking behaviours and un-availability of health care facilities and personnel [2,3].

Maternal mortality due to PE varies between (2-30%) and is much higher in rural areas. In Egypt, the prevalence of PE is (10.7%) in a community-based study while, in hospital-based studies ranged from (9.1-12.5%) of all deliveries [1,4,5].

Prevention of PE may be primary, secondary. Primary prevention involves avoiding pregnancy in women at high risk for PE, modifying lifestyles or improving nutrients intake in the whole population to decrease the incidence of the disease. Therefore, probably most of the cases of PE are unpreventable. Secondary prevention is based on interruption of known pathophysiological mechanisms of the disease before its establishment. Recent efforts have focused on the selection of high-risk women and have proposed an effective intervention, as early as it is possible, to avoid the disease or its severe complications [6].

The aim of the study was to create a nomogram for prediction of PE causing risk factors during antenatal care at a tertiary maternity hospital.

Patients and Methods

A cross-sectional study was conducted at Antenatal Care Clinic (ANC) in Assiut Women Health Hospital. This clinic is the main largest clinic in Assiut Governorate which provides antenatal care services for pregnant women.

A convenience sampling of pregnant women who attended at ANC for six months period from the beginning of May 2016 till the end of December 2016 and follow up waves ended in (March 2017). The total number of the study sample composed of 230 pregnant women was included and continued until the end of the study. All pregnant women who agree to participate in the study were included if gestational age was from 4th to 18th weeks and without mental disorders.

Two tools were utilized in the current study:

Tool 1

Structured interview questionnaire developed after reviewing the literature and previous research which were relevant to the present study, it included the following (3) parts:

Part 1: included the following:

1. Personal data scale which included: Age, name, telephone number, level of education, occupation …etc.

2. Family history of risk factors for PE such as previous PE, a family history of (diabetes mellitus, chronic hypertension, chronic kidney disease, cardiovascular diseases, thrombophilia, lupus, and smoking).

3. Maternal medical and obstetric history such as Gestational age at the beginning of the current study, consanguinity, age at marriage, age at first pregnancy, history of (preeclampsia, hypertension, diabetes mellitus.etc.).

Part 2

Physical examination of pregnant women, including (blood pressure, weight, signs of edema, and urine analysis).

During the first contact with the women that were enrolled, the physical examination (blood pressure, urine analysis, and signs of edema) was done.

Part 3

It included following up the pregnant women through three waves after the first contact with the pregnant women (4:18 weeks)

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