A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial.

BACKGROUND: Innovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women. METHODS AND FINDINGS: This was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) ≤23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020. Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention. CONCLUSIONS: In this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context. TRIAL REGISTRATION: ClinicalTrials.gov NCT03079388.

Vaginal Dryness and Beyond: The Sexual Health Needs of Women Diagnosed With Metastatic Breast Cancer.

While research on the sexual health of women with early stage cancer has grown extensively over the past decade, markedly less information is available to support the sexual health needs of women diagnosed with advanced breast cancer. Semistructured interviews were conducted with 32 women diagnosed with metastatic breast cancer (ages 35 to 77) about questions they had concerning their sexual health and intimate relationships. All participants were recruited from a comprehensive cancer center at a large Midwestern university. Three themes were examined: the role of sexual activity and intimate touch in participants' lives, unmet information needs about sexual health, and communication with medical providers about sexual concerns. Findings indicated that sexual activities with partners were important; however, participants worried about their own physical limitations and reported frequent physical (e.g., bone pains) and vaginal pain associated with intercourse. When women raised concerns about these issues in clinical settings, medical providers often focused exclusively on vaginal lubricants, which did not address the entirety of women's problems or concerns. In addition, women diagnosed with metastatic breast cancer reported needing additional resources about specialized vaginal lubricants, nonpenetrative and nongenitally focused sex, and sexual positions that did not compromise their physical health yet still provided pleasure.

Undertreatment of menopausal symptoms and novel options for comprehensive management.

OBJECTIVE: There is currently a gap in treatment options for menopausal symptoms and a need for comprehensive therapies that are safe and effective for postmenopausal women. This review discusses challenges in the management of menopausal symptoms and the effect of the Women's Health Initiative (WHI) study findings on current treatment patterns. It also examines present and future therapies. RESEARCH DESIGN AND METHODS: A literature search was conducted using Medline, the Cochrane Database, and the National Heart Lung and Blood Institute WHI website with the following search terms: primary care, menopause, vasomotor symptoms, hormone therapy, osteoporosis, and vaginal atrophy. Searches were limited to articles published between 1995 and 2009. RESULTS: Comprehensive therapies that target several aspects of menopause, such as vasomotor symptoms and chronic disease prevention, are currently hormone based. These hormone-based approaches are considered more effective than currently available nonhormonal therapies for the relief of menopausal symptoms. However, hormone therapy is not recommended for women at high risk for venous thromboembolic events, cardiovascular disease, and/or breast cancer. A need exists for novel therapies that mitigate menopausal symptoms, provide protection from osteoporosis, and encourage patient compliance without promoting cancer, heart disease, or stroke. Emerging modalities and strategies, such as the tissue selective estrogen complex (TSEC), Org 50081, MF101, and desvenlafaxine, may provide improved options for postmenopausal women. CONCLUSIONS: Several new menopausal therapies that may help to address the ongoing unmet need for safe and effective therapies for postmenopausal women are currently in development. In particular, the TSEC, which provides the benefits of both a selective estrogen receptor modulator and conjugated estrogens with an improved tolerability profile, may offer advantages over currently available treatment options. Limitations of this review include the narrow search criteria and limited search period.

[Ultrasonographic assessment of pregnancy development after endometriosis treatment]. / Ultrasonograficzna ocena rozwoju ciazy u kobiet leczonych z powodu endometriozy.

Investigated group comprised pregnant women after sterility treatment, which underwent obstetrical care in Institute of Obstetrics and Gynaecology Medical Academy of Lódz in years 1998-2000. In the first group were 25 pregnant women after endometriosis treatment, the second one 23 healthy pregnant women. At term were performed ultrasound examinations (biometry and estimated fetal weight) than were assessed neonatal weight in both groups. There were found the similar mean age in both groups, but in the group after treatment more women in age over 30 years were observed (not significant). The higher weights were observed in the group of healthy pregnant women in ultrasound fetal estimation before delivery (about 343.5 g) and neonatal weight after delivery (about 407 g) but without significance. There is possibility of the better vascular development in the feto-maternal circulation in the course of pregnancy in healthy women than after endometriosis treatment, but for the correct conclusions should be made further research on larger collectives. Ultrasound assessment is a useful method in prenatal diagnostic with possibility of precise analysis of the fetal development.

Risk assessment, symptoms, and signs as predictors of vulvovaginal and cervical infections in an urban US STD clinic: implications for use of STD algorithms.

OBJECTIVE: To identify clinical epidemiological correlates of cervical and vaginal infections and assess alternative algorithms, including two new reproductive tract infection (RTI) algorithms, for syndromic management of these infections. DESIGN, SETTING AND SUBJECTS: We prospectively studied clinical manifestations and risk correlates of cervical and vaginal infections in a randomly sampled group of 779 female patients seeking evaluation for a new problem at a Seattle STD clinic. METHODS: One experienced clinician performed standardised history, physical examination, and microscopy. Reference laboratories performed microbiological tests. Three levels of retrospective evaluation of algorithms included risk assessment and symptom review (RAS) alone; addition of speculum and bimanual examinations; and further addition of microscopy. RESULTS: (1) Chief complaint of abnormal vaginal discharge predicted a significantly lower rate of gonorrhoea (GC) or chlamydial infection (CT) than rates observed with no complaint of vaginal discharge. Only the elicited symptom of yellow vaginal discharge (not the more common symptoms of increased or malodorous vaginal discharge) predicted GC or CT. Chief complaint of abnormal vaginal discharge itself predicted trichomoniasis (TV) and bacterial vaginosis (BV), not cervical infection. Candida albicans was strongly associated with the chief complaint of vulvar pruritus, not with the chief complaint of abnormal vaginal discharge. (2) Applying these algorithms in STD clinics only to women with the chief complaint of abnormal vaginal discharge, rather than to all women, decreases sensitivity for GC or CT, without increasing positive predictive value (PPV). Criteria for inclusion of patients have more effect on the performance of these algorithms than do the levels of evaluation used. (3) A modified World Health Organisation (WHO) algorithm applied only to patients with symptoms of vaginal discharge, involving treatment of RAS positives for cervical infection, followed by treatment of vaginal infections and cervicitis based on examination of RAS negatives and positives, had a sensitivity of 50% and PPV of 33% for cervical infection, and very low sensitivity for BV, TV, and for vulvovaginal candidiasis (VVC). (4) An RTI algorithm derived from these data, and applied to all STD patients, involving RAS and examination of all RAS negatives, provided treatment to all cases of BV and TV associated with symptoms of vaginal discharge; treatment of all VVC associated with symptoms of vulvar pruritus; treatment for GC and GT to all RAS positives (using easily elicited risk factors) and to RAS negatives with signs of cervicitis or PID. This algorithm had a sensitivity of 87% and a PPV of 33% for GC or CT in this population, with its 24% prevalence of GC or CT. The sensitivity for BV, TV, and VVC greatly exceeded that of the modified WHO algorithm. (5) A modified RTI algorithm, involving examination rather than treatment of RAS positive women, no examination of RAS negatives, decreased the sensitivity for cervical infection to 55% but increased the PPV to 51%. CONCLUSIONS: Syndromic management of vaginal discharge offers relief of symptoms, prevention of transmission of trichomonas, and perhaps prevention of complications of BV. The 51% PPV of the modified RTI algorithm probably would warrant treatment and partner notification for GC and CT in settings with similar rates of GC and CT where more specific tests are lacking. However, as the prevalence of GC or CT decreases, the ratio of uninfected to infected who receive treatment with these algorithms would increase greatly, making the algorithms potential victims of their own success.

Practical tips for assessment and management of vulvar and vaginal human papillomavirus.

Human papillomavirus (HPV) infection has been strongly associated with intraepithelial neoplasia and cancers of the lower genital tract. Due to either better detection or increased incidence of this infection, there is a greater demand for colposcopy. Historically, clinicians have focused their colposcopic investigation on the cervix, often neglecting evaluation of the vulva and vagina. Because HPV is a multicentric disease, these areas should not be overlooked. Nurse colposcopists need to assess and manage women who have HPV-related vulvovaginal lesions that are either symptomatic or have the potential to advance to cancer.