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Objective: To evaluate the impact of introducing a uterine balloon tamponade (ESM‐UBT) device for managing severe postpartum hemorrhage (PPH), mainly due to uterine atony, in health facilities in India on the rates of PPH‐related maternal death and invasive procedures for PPH control. Methods: We used a quasi‐experimental, difference‐in‐difference (DID) design to compare changes in the rates of a composite outcome (PPH‐related maternal death and/or artery ligation, uterine compression sutures, or hysterectomy) among women delivering in nine intervention facilities compared with those delivering in two control facilities, before and after the introduction of ESM‐UBT. Results: The study sample included 214 123 deliveries (n = 78 509 before ESM‐UBT introduction; n = 47 211 during ESM‐UBT introduction; and n = 88 403 after ESM‐UBT introduction). After introduction of ESM‐UBT, there was a significant decline in the rate of the primary composite outcome in intervention facilities (21.0–11.4 per 10 000 deliveries; difference −9.6, 95% confidence interval −14.0 to −5.4). Change in the rate of the primary composite outcome was not significant in control facilities (11.7–17.2 per 10 000 deliveries; difference 5.4, 95% confidence interval −3.9 to 14.9). DID analyses showed there was a significant reduction in the rate of the primary composite outcome in intervention facilities relative to control facilities (adjusted DID estimate −15.0 per 10 000 points, 95% confidence interval −23.3 to −6.8; P = 0.005). Conclusion: Introduction of the ESM‐UBT in health facilities in India was associated with a significant reduction in PPH‐related maternal death and/or invasive procedures for PPH control. Introduction of a uterine balloon tamponade device for managing severe postpartum hemorrhage in health facilities in India significantly reduced maternal death and/or invasive procedures. [ABSTRACT FROM AUTHOR]

Objective: To understand facilitators, barriers, and perceptions of the Every Second Matters uterine balloon tamponade (ESM‐UBT) package implemented across 10 medical colleges in India, 3 years after the program was introduced. Methods: Semi‐structured interviews were conducted until thematic saturation in March 2020. Multiple provider cadres, including nurses, Obstetrics/Gynecology residents, professors, and program leads, were eligible. Interviews were transcribed and thematically coded using an inductive method. Results: Sixty‐two obstetric providers were interviewed. Facilitators of implementation included recurrent training, improved teamwork and communication, strong program leadership, and involvement of lower‐level facilities. Barriers to implementation included administrative hurdles, high staff turnover, language barriers, and resources required to reach and train lower‐level facilities. Overall, the majority of clinicians viewed the ESM‐UBT package as a useful intervention in aiding efforts to reduce maternal deaths from postpartum hemorrhage. Conclusions: Among 10 medical colleges in India the ESM‐UBT package is seen as a beneficial intervention for managing refractory atonic postpartum hemorrhage, and for reducing maternal morbidity and mortality. Identified facilitators of and barriers to implementation of the ESM‐UBT package in India should be used to guide future implementation efforts. Identified facilitators to implementation of the Every Second Matters uterine balloon tamponade should be leveraged for future implementation in other low‐resource settings. [ABSTRACT FROM AUTHOR]

Spermatogenesis is regulated by complex tissue specific gene expression in the testis to achieve normal male fertility. X‐chromosome specific TATA binding protein (TBP)‐associated factor 7L (hTAF7L) is one of the transcriptional regulator genes considered essential for spermatogenesis. The aim of this study was to evaluate the role of variants/mutations in the testis‐specific hTAF7L gene in non‐obstructive azoospermia and severe oligozoospermia male infertility. We studied 156 idiopathic non‐obstructive azoospermic, severe oligozoospermic infertile males and 50 fertile proven controls. Infertile males and control subjects were genotyped for variants of the hTAF7L gene using polymerase chain reaction and a direct Sanger sequencing approach. The odds ratio evaluated the association of hTAF7L gene variants with idiopathic male infertility. The variants found in the hTAF7L gene were subjected to an in‐silico analysis study. In infertile study subjects, we observed 11 single base pair nucleotide changes at various exons and three frameshift variants at exon 10 in the hTAF7L gene. We also found more than one variant in some non‐obstructive azoospermia and severe oligozoospermia infertile males along with control subjects. All these variants changed the amino acid sequences in the hTAF7L gene. However, similar changes were also seen in fertile subjects, and the differences were not statistically significant. In‐silico tools also predicted that the variants were likely to be benign. The variants in cDNA of the hTAF7L gene were typical SNPs. It is found that the hTAF7L gene is highly polymorphic and these missense variants are not directly associated with male infertility. However, we feel that more studies are needed to elucidate the role of multiple variants of the hTAF7L gene in the process of normal spermatogenesis. [ABSTRACT FROM AUTHOR]

Objective Design Setting Population Methods Main outcome measures Results Conclusions To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low‐dose oral misoprostol is superior to intravenous oxytocin.Open‐label, superiority randomised trial.Government hospitals in India.Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture.Participants received misoprostol (25 micrograms, orally, 2‐hourly) or titrated oxytocin through an infusion pump. All women had one‐to‐one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring.Caesarean birth.A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81–1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207–244 min, vs 194 min, 179–210 min; aOR 1.137; 95% CI 1.023–1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203–1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups.Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial. [ABSTRACT FROM AUTHOR]

The SRY initiates cascade of gene expression that transforms the undifferentiated gonad, genital ridge into testis. Mutations of the SRY gene is associated with complete gonadal dysgenesis in females with 46,XY karyotype. Primary amenorrhea is one of the clinical findings to express the genetic cause in 46,XY sex reversal. Here, we report a 26‐year‐old married woman presenting with primary amenorhea and complete gonadal dysgenesis. The clinical phenotypes were hypoplastic uterus with streak gonad and underdeveloped secondary sexual characters. The cytogenetic analysis confirmed 46,XY sex reversal karyotype of a female. Using molecular approach, we screened open reading frame of the SRY gene by PCR and targeted DNA Sanger sequencing. The patient was confirmed with nucleotide substitution (c.226C>A; p.Arg76Ser) at in HMG box domain of SRY gene that causes 46,XY sex reversal female. Mutation prediction algorithms suggest that alteration might be disease causing mutation and mutated (p.Arg76Ser) amino acid deleteriously affects HMG box nNLS region of SRY protein. Clinical phenotypes and in silico analysis confirmed that missense substitution (p.Arg76Ser) impaired nNLS binding Calmodulin‐mediated nuclear transport of SRY from cytoplasm to nucleus. The mutation affects down regulation of male sex differentiation pathway and is responsible for 46,XY sex reversal female with gonadal dysgenesis. [ABSTRACT FROM AUTHOR]

Introduction: HIV self-testing can increase coverage of essential HIV services. This study aimed to establish the acceptability, concordance and feasibility of supervised HIV self-testing among pregnant women in rural India.Methods: A cross-sectional, mixed methods study was conducted among 202 consenting pregnant women in a rural Indian hospital between August 2014 and January 2015. Participants were provided with instructions on how to self-test using OraQuick® HIV antibody test, and subsequently asked to self-test under supervision of a community health worker. Test results were confirmed at a government-run integrated counselling and testing centre. A questionnaire was used to obtain information on patient demographics and the ease, acceptability and difficulties of self-testing. In-depth interviews were conducted with a sub-sample of 35 participants to understand their experiences.Results: In total, 202 participants performed the non-invasive, oral fluid-based, rapid test under supervision for HIV screening. Acceptance rate was 100%. Motivators for self-testing included: ease of testing (43.4%), quick results (27.3%) and non-invasive procedure (23.2%). Sensitivity and specificity were 100% for 201 tests, and one test was invalid. Concordance of test result interpretation between community health workers and participants was 98.5% with a Cohen’s Kappa (k) value of k=0.566 with p<0.001 for inter-rater agreement. Although 92.6% participants reported that the instructions for the test were easy to understand, 18.7% required the assistance of a supervisor to self-test. Major themes that emerged from the qualitative interviews indicated the importance of the following factors in influencing acceptability of self-testing: clarity and accessibility of test instructions; time-efficiency and convenience of testing; non-invasiveness of the test; and fear of incorrect results. Overall, 96.5% of the participants recommended that the OraQuick® test kits should become publicly available.Conclusions: Self-testing for HIV status using an oral fluid-based rapid test under the supervision of a community health worker was acceptable and feasible among pregnant women in rural India. Participants were supportive of making self-testing publicly available. Policy guidelines and implementation research are required to advance HIV self-testing for larger populations at scale. [ABSTRACT FROM AUTHOR]

Background. Postpartum hemorrhage is the most common cause of maternal deaths worldwide, the majority of which occur in low-resource settings. Uterine balloon tamponade (UBT) is an effective method of addressing uncontrolled postpartum hemorrhage (PPH) from uterine atony; however, UBT devices are often not affordable. We report on three novel uses of an ultra-low-cost condom uterine balloon tamponade (ESM-UBT) device. Cases. ESM-UBT devices were used in innovative ways to arrest severe uncontrolled pregnancy-related hemorrhage among three women in India and Tanzania. The first had sustained deep vaginal lacerations, the second a cervical pregnancy, and the third a complete molar pregnancy. Conclusion. The ESM-UBT device may be useful for control of obstetric hemorrhage caused by complex vaginal tears as well as cervical and molar pregnancies. [ABSTRACT FROM AUTHOR]

Introduction: The chromosomal anomalies are the most significant cause of human genetic disorders. Various types of structural and numerical chromosome aberrations have been identified in clinically suspect of genetic disorders. These aberrations are involved in different kinds of syndromes, infertility, amenorrhea, recurrent pregnancy loss, developmental delay, disorder of sexual development, congenital abnormalities and dysmorphic features etc. Aim: To determine various types of structural and numerical chromosome aberrations and its frequencies from hospital referred patients. Materials and Methods: In the present cross-sectional study, chromosomal analysis was done for various types of suspected 2215 referred patients. The patients were referred from, mainly, Obstetrics and Gynaecology, Paediatrics departments of Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India during the period of January 2000 to June 2019. Results: The overall frequency of chromosomal abnormalities was 12.23% (271/2215). Out of 271 cytogenetic abnormal patients, numerical chromosome abnormalities were found in 204 (75.28%) and structural chromosome abnormalities were detected in 67 (24.72%) patients. Abnormal cytogenetic findings were observed in 164 of 342 Down syndrome (47.95%), 36 of 383 Primary amenorrhea (9.40%), 20 of 768 recurrent pregnancy loss (2.60%), 30 of 473 male infertility (6.34%), 6 of 72 Ambiguous genitalia (8.33%), 13 of 147 congenital abnormalities (8.84%), 2 of 30 psychiatric disorder (6.66%) of patients. Conclusion: Cytogenetic analysis is essential for diagnosis of genetic disorders and to provide precise diagnosis. Chromosomal analysis helps in appropriate genetic counseling to assess the risk of recurrences and to take measures for prevention and management of inherited genetic diseases and disorders. Moreover, there are no registries or databases of genetic disorders in India. Compilation of these kinds of studies will help in making databases or registries of genetic disorders. [ABSTRACT FROM AUTHOR]

Nitika Pant Pai and colleagues report the results of offering a round-the-clock rapid HIV testing program in a rural labor ward setting in India. [ABSTRACT FROM AUTHOR]

Background: In India, 3.6 million pregnancies are affected by preterm birth annually, with many infants dying or surviving with disability. Currently, there is no simple test available for screening all women at risk of spontaneous PTB in low income setting, although high resource settings routinely use cervical length measurement and cervico-vaginal fluid fetal fibronectin for identification and care of women at risk due to clinical history. In rural India, where the public health system has limited infrastructure, trained staff and equipment, there is a greater need to develop a low-cost screening approach for providing early referral, treatment and remedial support for pregnant women at risk of preterm birth. There is interest in the use of a salivary progesterone test as a screening tool preliminary evidence from India, Egypt and UK has shown promise for this type of test. The test requires further validation in a low resource community setting. Methods: The Promises study aims to validate and test the feasibility of introducing a low-cost salivary progesterone preterm birth prediction test in two rural districts in India with high rates of prematurity. It is a prospective study of 2000 pregnant women recruited from Panna and Satna in Madhya Pradesh over approximately 24 months. Demographic and pregnancy outcome data will be collected, and pregnancies will be dated by ultrasound sonography. Saliva progesterone will be measured by ELISA in samples obtained between 24–28 weeks of gestation. The association between salivary progesterone and preterm birth will be determined and the utility of salivary progesterone to predict preterm birth < 34, as well as < 30 and < 37 weeks assessed. Additional qualitative data will be obtained in terms of acceptability and feasibility of saliva progesterone testing and knowledge of PTB. Discussion: A validated cost-effective saliva test, which has potential for further adaptation to a 'point of care' setting will allow early identification of pregnant women at risk of preterm birth, who can be linked to an effective pathway of care and support to reduce preterm birth and associated adverse consequences. This will reduce both economic and emotional burden on the affected women and their families. [ABSTRACT FROM AUTHOR]

Background: Testing pregnant women for HIV at the time of labor and delivery is the last opportunity for prevention of mother-to-child HIV transmission (PMTCT) measures, particularly in settings where women do not receive adequate antenatal care. However, HIV testing and counseling of pregnant women in labor is a challenge, especially in resource-constrained settings. In India, many rural women present for delivery without any prior antenatal care. Those who do get antenatal care are not always tested for HIV, because of deficiencies in the provision of HIV testing and counseling services. In this context, we investigated the impact of introducing round-the-clock, rapid, point-of-care HIV testing and counseling in a busy labor ward at a tertiary care hospital in rural India.Methods and Findings: After they provided written informed consent, women admitted to the labor ward of a rural teaching hospital in India were offered two rapid tests on oral fluid and finger-stick specimens (OraQuick Rapid HIV-1/HIV-2 tests, OraSure Technologies). Simultaneously, venous blood was drawn for conventional HIV ELISA testing. Western blot tests were performed for confirmatory testing if women were positive by both rapid tests and dual ELISA, or where test results were discordant. Round-the-clock (24 h, 7 d/wk) abbreviated prepartum and extended postpartum counseling sessions were offered as part of the testing strategy. HIV-positive women were administered PMTCT interventions. Of 1,252 eligible women (age range 18 y to 38 y) approached for consent over a 9 mo period in 2006, 1,222 (98%) accepted HIV testing in the labor ward. Of these, 1,003 (82%) women presented with either no reports or incomplete reports of prior HIV testing results at the time of admission to the labor ward. Of 1,222 women, 15 were diagnosed as HIV-positive (on the basis of two rapid tests, dual ELISA and Western blot), yielding a seroprevalence of 1.23% (95% confidence interval [CI] 0.61%-1.8%). Of the 15 HIV test-positive women, four (27%) had presented with reported HIV status, and 11 (73%) new cases of HIV infection were detected due to rapid testing in the labor room. Thus, 11 HIV-positive women received PMTCT interventions on account of round-the-clock rapid HIV testing and counseling in the labor room. While both OraQuick tests (oral and finger-stick) were 100% specific, one false-negative result was documented (with both oral fluid and finger-stick specimens). Of the 15 HIV-infected women who delivered, 13 infants were HIV seronegative at birth and at 1 and 4 mo after delivery; two HIV-positive infants died within a month of delivery.Conclusions: In a busy rural labor ward setting in India, we demonstrated that it is feasible to introduce a program of round-the-clock rapid HIV testing, including prepartum and extended postpartum counseling sessions. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion (82%) of rural women who were unaware of their HIV status when admitted to the labor room. In addition, 11 (73%) of a total of 15 HIV-positive women received PMTCT interventions because of round-the-clock rapid testing in the labor ward. These findings are relevant for PMTCT programs in developing countries. [ABSTRACT FROM AUTHOR]