Loop mediated isothermal amplification assay for detection of Trichomonas vaginalis in vaginal swabs among symptomatic women from North India.

Trichomonas vaginalis is one of the most common curable sexually transmitted pathogens infecting both men and women worldwide. Unlike traditional methods such as microscopy and culture, nucleic acid amplification tests rapidly detect this agent, assisting in treatment. Conventional polymerase chain reaction (PCR), the loop-mediated isothermal amplification (LAMP), and the Xpert TV assay were evaluated using 28 microscopy positive T. vaginalis samples and 125 microscopy negative samples from symptomatic females of reproductive age. The sensitivity of all tests was 100% and the specificity was 100%, 100%, and 99·2% for PCR, Xpert TV, and LAMP, respectively. The inter-rater reliability was excellent for PCR: Xpert TV (kappa-coefficient = 1) and good for LAMP assay: Xpert TV/PCR (kappa-coefficient = 0·98) and conventional PCR: LAMP (kappa-coefficient = 0·98). The study highlights the importance of PCR for screening T. vaginalis in women, particularly in laboratories where the Xpert-TV assay is not available or not affordable. The LAMP assay showed a lower positive predictive value which merits further evaluation. SIGNIFICANCE AND IMPACT OF THE STUDY: Trichomonas vaginalis is a common sexually transmitted pathogen associated with considerable morbidity and risk of complications. Due to the limitations of traditional diagnostic modalities, three molecular assays were compared: conventional polymerase chain reaction (PCR), Xpert TV assay, and loop mediated isothermal amplification (LAMP) assay for detecting T. vaginalis in symptomatic females. All tests had a sensitivity of 100% and the inter-rater reliability was excellent for PCR: Xpert TV, and good for LAMP assay: Xpert TV/PCR. The translational impact of this study lies in the possible use of conventional PCR and LAMP in laboratories where the Xpert TV assay is not available or not affordable.

INFIX/EXFIX: Innovation managing pelvic fractures in difficult scenarios.

Pelvic fractures complicated by the presence of visceral injuries, open fractures and urethral or bladder injuries pose a significant challenge to treat. In these conditions internal fixation is usually contraindicated. External fixators, though a potential solution, have disadvantages like loss of reduction, pin tract infection and loosening. INFIX, a novel technique has been effective in managing anterior ring fractures and can be used as a substitute for internal fixation. We describe use of INFIX as EXFIX in three case scenarios where passing INFIX rod internally was precluded with favorable outcomes.

The effect of spinal hyperbaric bupivacaine-fentanyl or hyperbaric bupivacaine on uterine tone and fetal heart rate in labouring women: a randomised controlled study.

The mechanism for fetal heart rate abnormalities following spinal opioids remains controversial. We evaluated uterine tone, using an intra-uterine pressure catheter, and fetal heart rate abnormalities in 30 women in spontaneous labour with cervical dilation of 3-5 cm having combined spinal-epidural analgesia. Women were randomly assigned to receive a spinal with 2.0 mg hyperbaric bupivacaine plus 15 µg fentanyl, or 2.5 mg hyperbaric bupivacaine. The primary outcome measure was an increase > 10 mmHg in baseline uterine tone in the 30-min period following spinal injection. Only three (20%) women who had a bupivacaine-fentanyl spinal showed a > 10 mmHg increase in baseline tone vs. none who had bupivacaine (p = 0.63). The mean (SD) baseline uterine tone after the spinal injection was 13.3 (7.0) mmHg in the bupivacaine-fentanyl group and 7.7 (2.5) mmHg in the bupivacaine group (p = 0.01). Seven (47%) in the bupivacaine-fentanyl group showed new onset fetal heart rate changes during the 30-min period after the spinal, compared with two (13%) in the bupivacaine group (p = 0.04); however, these were transient and responded to intra-uterine resuscitation. Pain scores, sensory and motor block as well as neonatal outcomes were comparable between the groups. We found that raised baseline uterine tone was not more frequent when using bupivacaine-fentanyl rather than bupivacaine in the spinal component of combined spinal-epidural, although absolute values of baseline tone were higher, and fetal heart rate changes more frequent, in the former group.

Labour induction with an intermediate-dose oxytocin regimen has advantages over a high-dose regimen.

A total of 200 women planned for labour induction were randomised to receive high-dose oxytocin (6 mU/min with similar increments every 45 min) or intermediate-dose oxytocin (3 mU/min with similar increments every 45 min). Oxytocin solution was prepared with 30 units in 500 ml saline with which the infusion rate in ml/h is numerically equal to oxytocin in mU/min. We observed that the caesarean rate (18% vs 6%, p = 0.009), contraction abnormalities (35% vs 14%, p = 0.0005) and neonatal bilirubin levels (7.99 ± 2.70 vs 6.80 ± 2.65, p = 0.002) were higher with high-dose than with intermediate-dose. The induction-delivery interval (IDI) was similar (10 h 13 min with high-dose and 11 h 5 min with intermediate-dose; p = 0.237, NS). Nulliparous women benefited more with intermediate-dose as the caesarean rate was higher with high-dose (24.6% vs 7.9%, p = 0.011). Although the caesarean rate was higher in multiparous women with high-dose oxytocin, it was statistically not significant (5.7% vs 2.7%; p = 0.609). Oxytocin regimens for labour induction are usually high-dose (4-6 mU/min) or low-dose (1-1.5 mU/min). The former is associated with more contraction abnormalities and the latter with prolonged IDI; both result in an increased caesarean rate. In order to offset these disadvantages, an intermediate- dose regimen was selected. The increment interval of 45 min was selected in accordance with the pharmacokinetics of oxytocin. We observed a lower caesarean rate when compared with the high-dose regimen, without any increase in the IDI. Hence, we propose that the intermediate-dose oxytocin regimen should be preferred to the high-dose regimen for labour induction.

Mean gestation at delivery and histological chorioamnionitis correlates with early-onset neonatal sepsis following expectant management in pPROM.

This prospective observational study was carried out in India among 100 women with preterm pre-labour rupture of membranes (pPROM) between 26(0/7)-33(0/7) weeks on expectant management in order to correlate early-onset neonatal sepsis (EONS) with various features of chorioamnionitis. The incidence of pPROM during the study period of 1.5 years was 7%. The mean gestation at pPROM was 30(6/7) ± 1.8 weeks and at delivery was 32(1/7) ± 1 weeks. Features of chorioamnionitis in the form of clinical, microbiological, histological or a combination of these were observed in 70/100 women. Clinical chorioamnionitis was seen in 16%, bacterial isolates were present in 30% on cervical swab and in 39% on placental membrane culture and 19% had histological chorioamnionitis. EONS was present in 23/97 (24%). Clinical chorioamnionitis (p = 0.069), bacterial isolates on cervical swab (p = 0.56) or placental membranes (p = 0.39) were not found to predict EONS; whereas histological chorioamnionitis (p = 0.002) and lower gestation at delivery (p = 0.013) were significantly associated with EONS.

Systematic review of the results of fenestrated endovascular aortic repair in octogenarians.

INTRODUCTION: With the increasing life expectancy of Western populations, more octogenarians are presenting with large abdominal aortic aneurysm (AAA). Endovascular repair offers a less invasive alternative and older patients who may not have been offered open repair in the past are now being considered for elective repair with this approach. Age in isolation may not be the only consideration in recommending elective aneurysm repair. We aimed to review the literature on complex endovascular AAA repairs (mainly fenestrated endovascular aortic repair [FEVAR]) in octogenarians. METHODS: A literature search was conducted using the Ovid Medline®, Embase® and Cochrane Library databases for articles published up to January 2022. All English language publications from 1995 onwards were eligible for inclusion. Search terms included: "FEVAR", "F-EVAR", "fenestrated EVAR", "fenestrated endovascular aortic repair", "fenestrated endovascular aneurysm repair", "fenestrated AAA repair", "fenestrated endograft", "fenestrated stent graft", "fenestrated", "endograft", "EVAR", "octogenarian", "elderly", "above 80" and "over 80". METHODS: The literature search identified 134 potential articles. Following qualitative assessment by two independent appraisers, this was refined to 11 studies, in accordance with the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) statement. RESULTS: The primary outcome measure was 30-day mortality, which was highly variable, ranging from 0% to 9% in octogenarians and from 0% to 5% in non-octogenarians. However, these differences were only found to be statistically significant in two studies. The secondary outcome measures included technical success rates, major adverse events, reintervention rates, freedom from reintervention, target vessel patency, freedom from target branch instability, and length of hospital and intensive care unit stay. No statistically significant differences were found between octogenarians and non-octogenarians. Long-term survival was significantly lower for octogenarians in two studies. CONCLUSIONS: The perioperative outcomes of FEVAR in octogenarians are comparable with those of younger patients. FEVAR therefore appears to be an acceptable option for complex endovascular aneurysm repairs in carefully selected octogenarians. Nevertheless, this review highlights the paucity of published data on the outcomes of endovascular repair of complex aneurysms in octogenarians.

A new objective scoring system for the prediction of successful induction of labour.

A prospective study was done in 311 women undergoing induction of labour for the formulation of a new score, which will be more objective than the conventional Bishop's score. Pre-induction cervical assessment was done by the transvaginal sonographic parameters followed by the digital examination. Labour induction was successful in 79.09%. A new score was formulated using the parameters having independent association and weighting of individual components was given according to its regression coefficients. A new score with a maximum value of 13 was proposed. The best cut-off point for the new score in receiver operating characteristics curve was six with a sensitivity of 95.5% and specificity of 84.6%. The new score was found to have a better area under the curve than the conventional score.

Cervical length compared to Bishop's score for prediction of pre-term birth in women with pre-term labour.

Cervical length (by transvaginal sonography) was compared to Bishop's score (by digital examination of cervix) for prediction of pre-term birth in women with pre-term labour. The study group was 100 women with a singleton pregnancy with pre-term labour between 26-36 weeks' gestation. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cervical length ≤2.5 cm ( by TVS) to predict delivery within 48 h and 7 days of admission were 62.5%, 89.5%, 65.2%, 88.3%, and, 60.0%, 96.9%, 91.3%, 81.8%, respectively. Similar values of Bishop's score ≥5 were 62.5%, 85.52%, 57.69%, 87.83%, and, 62.8%, 93.8%, 84.6%, 82.4%, respectively. To conclude, both Bishop's score ≥5 and reduced cervical length of ≤2.5 cm (by TVS) can predict the risk of pre-term delivery within 48 h or 7 days.

Risk factors for early onset severe pre-eclampsia and eclampsia among north Indian women.

A case-control study was conducted in India between April 2007 and January 2008, to identify the clinical and historical risk factors associated with early onset pre-eclampsia/eclampsia (PE-E) in women attending a tertiary care hospital in North India. The study group comprised 100 women with early onset severe pre-eclampsia/eclampsia (≤34 weeks) and a control group of 100 women with mild non-proteinuric hypertension (>34 weeks). A detailed history including past, personal and family history, pregnancy outcome including delivery details and perinatal outcome and available investigations were recorded in a pre-designed proforma. Multiple logistic regression analysis was used to determine the risk factors for pre-eclampsia. The risk factors that were associated with increased risk of early onset severe PE-E were: history of PE-E in a previous pregnancy (adjusted odds ratio, aOR 71.40); exposure to passive smoking (aOR 16.40); inadequate antenatal supervision (aOR 15.21); family history of hypertension in one or more 1st-degree relative (aOR 8.92); living in a joint family (aOR 6.93); overweight (>120% to 150% of pre-pregnancy ideal body weight, aOR 4.65) and lower socioeconomic class (Kuppuswamy's class III-V) (aOR 3.00). Based on the above risk factors, a risk model can be constituted as practised in other places and implemented in the primary preventive measure of early-onset severe pre-eclampsia among the North Indian women attending this tertiary care hospital.

Cervical length and cervicovaginal HCG for prediction of pre-term birth in women with signs and symptoms of pre-term labour.

The study group consisted of 100 women with a singleton pregnancy with pre-term labour between 26-36 weeks' gestation. Cervicovaginal secretions were collected for HCG assay and cervical length was measured by transvaginal sonography (TVS). These parameters were analysed to predict pre-term birth. The pre-term delivery rate was 55%; 24% delivered within 48 h and 11% within 7 days of admission. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cervical length or=45 mIU/ml was the optimal cut-off, with a sensitivity, specificity, PPV and NPV for predicting delivery within 48 h and 7 days to be 95.8%, 73.7%, 53.5% and 98.2% and 85.7%, 80%, 69.8% and 91.2%, respectively. Combining either qualitative or quantitative HCG assay with cervical length significantly increased the sensitivity and NPV of cervical length alone for prediction of pre-term delivery both within 48 h and 7 days. It was concluded that increased cervicovaginal HCG and reduced cervical length predicted an increased risk of pre-term delivery in women with pre-term labour. Qualitative cervicovaginal HCG assay may be used as a bedside test to predict pre-term delivery within 48 h or within 7 days.

Advanced germ cell malignancies of the ovary: should neo-adjuvant chemotherapy be the first line of treatment?

Malignant germ cell tumours of the ovary, though classically known for 'young age' and 'early stage' at presentation, are not uncommonly identified at advanced stages. Little is available in literature on the role of neo-adjuvant chemotherapy (NACT) in this group of tumours. Two patients with advanced stage ovarian germ cell tumours, including one with 45XO/46XY chromosomal mosaicism, were treated at our Institute with neo-adjuvant chemotherapy with Bleomycin, Etoposide and Cisplatin followed by surgery. Besides marked clinical improvement, intraoperatively both the patients presented no difficulty otherwise expected with widespread tumours, and histopathology report revealed no evidence of viable tumour. The article discusses the experience and suggested course of management of these tumours with NACT, which could be offered to patients with advanced malignancy in whom high surgical morbidity is anticipated or in whom only an operative biopsy was performed at laparatomy. Behaviour and management guidelines of dysgenetic gonads with XY mosaicism have also been discussed.

Intravaginal use of natural micronised progesterone to prevent pre-term birth: a randomised trial in India.

In a prospective, randomised trial, 100 pregnant women with >/= one prior spontaneous pre-term birth were randomised into two groups. Group 1 women received 100 mg natural micronised progesterone intravaginally once daily from 20-24 weeks' gestation until 36 weeks. Group 2 women did not receive progesterone. Both groups were regularly supervised until delivery. Pre-term birth (<37 and <34 weeks) and other maternal, neonatal outcomes were primary and secondary outcomes, respectively. Chi-square test and Fisher exact test were used to compare categorical variables. Independent sample t-test and one-way ANOVA were used to compare continuous variables and multiple comparisons, respectively. Pre-term births <37 weeks were significantly lower in Group 1 (12% vs 38%, p = 0.002), but pre-term births <34 weeks were similar. The mean birth weight of neonates born to women in Group 1 was significantly higher (2800 vs 2,500 g, p = 0.023). We concluded intravaginal administration of 100 mg of natural micronised progesterone significantly reduced the incidence of pre-term birth <37 weeks in women with > or = one prior pre-term birth. Future research is warranted to assess the long-term safety and efficacy of progesterone.

First and second trimester induced abortions in women with cardiac disorders: a 12-year analysis from a developing country.

This was a retrospective analysis of induced abortions (1st and 2nd trimester) in women with cardiac disease over a 12-year period (September 1994-December 2006). Of the 3,096 women who underwent an induced abortion during this period, 65 (2.1%) had an associated cardiac disease (NYHA class I or II = 58, class III or IV = 7). Their mean age was 29.6 years and 48/65 (73.9%) had opted for concurrent sterilisation. Nearly all 1st trimester abortions (52/53) were performed by suction evacuation. Among the 12 women undergoing 2nd trimester abortions, seven received vaginal misoprostol with or without oral mifepristone, four received varying combinations of intracervical dinoprostone, extra-amniotic saline (EAS) and oxytocin and elective hysterotomy was performed in one. Complications observed among the 1st trimester terminations were incomplete abortion in 1/53 (1.8%) and prolonged bleeding in 3/53 (5.6%). Method failure was the only complication seen in 2/12 (16.6%) 2nd trimester abortions. There was no major morbidity or mortality. Mifepristone and misoprostol used for 2nd trimester induced abortions were found to be safe in the few women so treated.

Pregnancy complicated by severe chronic hypertension: a 10-year analysis from a developing country.

OBJECTIVE: To assess pregnancy outcome in patients with severe chronic hypertension. METHODS: A retrospective analysis of a 10-year period (1995-2004) in a referral hospital in northern India. The outcome was compared with those women with mild chronic hypertension who registered in the hypertensive disorders with pregnancy clinic immediately before and after each woman with severe chronic hypertension. RESULTS: Hospital data identified 25 such women. Superimposed preeclampsia (36.4% versus 8%), preterm delivery (86.4% versus 42%), and perinatal mortality (27.2% versus none) were increased in patients with severe chronic hypertension as compared to those with mild hypertension. CONCLUSIONS: The small number of cases reflects the lack of antenatal supervision in developing countries. A much larger number of women are referred in the third trimester with eclampsia or severe preeclampsia, at which time it is not possible to identify whether or not they had underlying hypertension. Adverse events were found to occur more often in patients with severe chronic hypertension compared with those with mild hypertension.

A polyherbal vaginal pessary with spermicidal and antimicrobial action: evaluation of its safety.

A polyherbal vaginal pessary (Praneem) has been formulated that has antimicrobial properties against genital pathogens in addition to spermicidal action. Thus, it has dual potential as a barrier method for contraception and for providing protection against some sexually transmitted infections. The present study reports the findings of a multicentre trial that was conducted to evaluate the safety of this product. Trials were carried out in 23 women in three centres in India: the Postgraduate Institute of Medical Education and Research, Chandigarh; Safdarjang Hospital, New Delhi; and Kamla Nehru Memorial Hospital, Allahabad. Thorough clinical and pelvic examinations were carried out as well as cervical cytology, blood biochemistry and haematology before and after use of the polyherbal pessary intravaginally once daily for 7 consecutive days. No toxicity was observed on clinical examination or by laboratory investigations. Daily intravaginal use of this pessary for 7 days had no adverse effects on cervical cytology or on metabolic and organ functions.

HMG I/Y regulates long-range enhancer-dependent transcription on DNA and chromatin by changes in DNA topology.

The nature of nuclear structures that are required to confer transcriptional regulation by distal enhancers is unknown. We show that long-range enhancer-dependent beta-globin transcription is achieved in vitro upon addition of the DNA architectural protein HMG I/Y to affinity-enriched holo RNA polymerase II complexes. In this system, HMG I/Y represses promoter activity in the absence of an associated enhancer and strongly activates transcription in the presence of a distal enhancer. Importantly, nucleosome formation is neither necessary for long-range enhancer regulation in vitro nor sufficient without the addition of HMG I/Y. Thus, the modulation of DNA structure by HMG I/Y is a critical regulator of long-range enhancer function on both DNA and chromatin-assembled genes. Electron microscopic analysis reveals that HMG I/Y binds cooperatively to preferred DNA sites to generate distinct looped structures in the presence or absence of the beta-globin enhancer. The formation of DNA topologies that enable distal enhancers to strongly regulate gene expression is an intrinsic property of HMG I/Y and naked DNA.

LXIII Cold Spring Harbor Symposium on Quantitative Biology: Mechanisms of Transcription, 3-8 June 1998.

A new perspective is emerging in the transcription field towards understanding gene regulation not only at its most fundamental level but also in the context of chromatin, nuclear compartmentalization, and physiological processes. This direction is being fueled by several key observations. Among them is the discovery of multi-protein complexes whose components reveal a link between gene activity, nuclear structure, and cellular signaling pathways. This information will no doubt be extended by identifying expanded regulatory circuitry using the microchip oligonucleotide array technology. In addition to elucidating the regulatory consequences of these intricate connections, another frontier will be to analyze gene expression within chromosomes. This requires deciphering the mechanism of action of a variety of DNA elements that create a genetic domain such as locus control regions, distal enhancers, insulators, silencers, and matrix attachment regions. Hopefully, with the development of new assays these elements can be as rigorously defined as promoters have been. We can also look forward to capturing critical transcriptional processes by increasingly refined structural analyses. Thus, the scope of problems being addressed in gene regulation has been greatly expanded and the opportunity exists to answer very sophisticated questions in the future.