Comparison of efficacy between levonorgestrel intrauterine system and dienogest in adenomyosis: a randomized clinical trial.

Background: Medical management of adenomyosis is an emerging perspective in modern gynecology. Though levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG) effectively relieve symptoms in adenomyosis, neither has been approved for the same indication. Our study aims to compare the efficacy and safety of these progestins in treating adenomyosis. Objective: To study the efficacy and safety of LNG-IUS versus DNG in patients with symptomatic adenomyosis. Design: Open-labeled, parallel, single-centered, randomized clinical trial. Methods: Patients with adenomyosis-associated pain with or without abnormal uterine bleeding were randomly allocated to either LNG-IUS group or DNG group. The primary outcome was a reduction in painful symptoms after 12 weeks of treatment measured by visual analog scale (VAS) score. Changes in menstrual blood loss (MBL), improvement in quality of life (QoL), and adverse drug reactions were also analyzed. Results: The VAS score significantly decreased from baseline in both groups. The baseline and post-treatment VAS scores in the LNG-IUS group were 6.41 ± 1.07 and 3.41 ± 1.04 (p = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 (p = <0.001), respectively. A significantly greater proportion of patients in the LNG-IUS group experienced lighter MBL as compared to the DNG group [27/30 (90%) in the LNG-IUS group versus 17/22 (77.2%) in the DNG group (p = 0.006)]. Both the groups had improvement in QOL scores calculated by the World Heath Organisation QOL scale (WHOQOL BREF) questionnaire; however, it was more pronounced in the DNG group [(28.76 ± 30.47 in the LNG-IUS group versus 48.26 ± 44.91 in the DNG group (p = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions. Conclusion: DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis. Trial registration: The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.

Comparison of effectiveness and safety of Mirena (LNG-IUS) with dienogest for treatment of adenomyosis Adenomyosis is a condition affecting women, typically aged 40­50, but its incidence is rising in younger women, impacting fertility. It causes painful symptoms like dysmenorrhea, dyspareunia, chronic pelvic pain, and heavy menstrual bleeding. Managing symptoms is crucial, and medical approaches include levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG). LNG-IUS is reversible contraception, approved for eight years, effectively treating symptoms. DNG, a newer progestin, is effective for endometriosis, but evidence for adenomyosis is limited. This single-center, open-label randomized clinical trial compared LNG-IUS and DNG in treating adenomyosis. Women over 20 with pelvic pain were diagnosed using ultrasound and met specific criteria. After informed consent, participants were assigned randomly to LNG-IUS or DNG groups. Treatment outcomes, including pelvic pain, quality of life (QoL), and adverse effects, were assessed over 12 weeks. Out of 84 assessed, 74 women were recruited, with 34 in each group analyzed. After 12 weeks, both groups showed significantly reduced pelvic pain (VAS scores), but no significant difference was found between the groups. LNG-IUS resulted in a significantly greater reduction in heavy menstrual bleeding (HMB), whereas DNG showed better improvement in overall QOL. Adverse effects were similar in both groups, with hot flushes reported in the DNG group. This study is one of the few comparing LNG-IUS and DNG for adenomyosis, finding both effective for symptom relief. Although LNG-IUS was superior in reducing HMB, DNG showed better overall improvement in QoL. Safety profiles were similar. Previous studies support the efficacy of DNG in reducing adenomyosis symptoms. To conclude, both LNG-IUS and DNG effectively alleviate adenomyosis symptoms, with LNG-IUS superior in reducing heavy menstrual bleeding and DNG showing better overall improvement in QOL. DNG is a viable and effective alternative to LNG-IUS.

Uterine Artery Pseudoaneurysm after Cervical Cerclage: A Rare Case and Its Management Through Uterine Artery Embolization.

Background: Uterine arterial pseudoaneurysm (UAP) is a rare cause of vaginal bleeding. Usually, UAP follows cesarean section, uterine curettage, vaginal delivery, or cervical conization and must be considered in the differential diagnosis. Here we report a very unusual case of UAP causing intra-abdominal and vaginal bleeding after cervical cerclage and its successful management through the endovascular route. Case Presentation: This 30-year-old P2L1A2 woman presented with vaginal bleeding after 7 days following hysterotomy for termination of pregnancy. At 16 weeks of her index pregnancy, she underwent cervical cerclage for cervical insufficiency, followed by an emergency hysterotomy at 20 weeks for profuse vaginal bleeding after failed medical management. On ultrasound and contrast-enhanced computed tomography (CECT), uterine dehiscence and a cervical pseudoaneurysm were detected. Dehiscence was repaired surgically, and pseudoaneurysm was successfully managed by uterine artery embolization. Conclusion: UAP is an uncommon cause of vaginal bleeding; however, it should be considered in the differential diagnosis of a woman with unusual vaginal bleeding, particularly in the postpartum or postoperative setting like cesarean section, uterine curettage, cervical conization, or cerclage. Endovascular uterine artery embolization is a minimally invasive, effective, preferred, and safe method for managing UAP.

Familial recurrent molar pregnancy: positive for KHDC3L gene mutation.

Recurrent hydatidiform moles are defined by the occurrence of two or more molar pregnancies in the same patient. These can be sporadic or familial where familial recurrent hydatidiform mole is rare and inherited as an autosomal recessive condition. Here, we present a case of four consecutive complete molar pregnancies with similar history in the sisters, who was diagnosed with fourth complete molar pregnancy. She underwent suction and evacuation followed by weekly serum ß-hCG. On genetic analysis, she was found to be homozygous for KHDC3L gene mutation. She was advised for evaluation of her sisters and to consider In vitro fertilization (IVF) with donor ovum or adoption. Prompt suspicion and diagnosis along with counselling of the couple regarding the fertility options available to them are the main aspects of this disease to protect them from repeated physical as well as psychological trauma.

Individualized lifestyle intervention in PCOS women (IPOS): a study protocol for a multicentric randomized controlled trial for evaluating the effectiveness of an individualized lifestyle intervention in PCOS women who wish to conceive.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine condition which affects women in the reproductive age group. South Asian women with PCOS have a higher risk of insulin resistance and metabolic disorder compared to women from other ethnic backgrounds. Lifestyle interventions such as dietary advice and physical exercise are recommended as a first-line management option for infertile women with PCOS. Most of the randomized controlled trials evaluating the role of lifestyle interventions in infertile PCOS women were characterized by methodological issues. The uptake of lifestyle modifications as a treatment strategy in the South Asian population is complicated by a difficult-to-change conventional high-carbohydrate diet and limited availability of space for physical activity in the region. METHODS: The study is designed as an open-label, multicentre, randomized controlled trial in South Asian women with PCOS. Women attending the fertility clinic will be screened for eligibility, and women aged between 19 and 37 years who have been diagnosed with PCOS and wishing to conceive will be invited to participate in the trial. We will include women with body mass index (BMI) between ≥ 23 and ≤ 35 kg/m2 and duration of infertility ≤ 3 years. We plan to randomize women with PCOS into two groups: group A will receive the intervention which will consist of individualized advice on diet and physical exercise along with a telephonic reminder system and follow-up visits, and group B (control) will receive one-time advice on diet and physical exercise. Both groups will receive up to three cycles of ovulation induction with letrozole after 3 months of randomization during the 6-month treatment period. The primary outcome of the trial will be the live birth following conception during the intervention period. The secondary outcomes include clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, ectopic pregnancy rate, stillbirth, time to pregnancy, mean weight loss, differences in anthropometric parameters, improvement in menstrual regularity and quality of life score. DISCUSSION: The IPOS trial results could help clarify and provide more robust evidence for advocating an individualized lifestyle intervention in PCOS women who wish to conceive. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023.

Identification of Candidate Immune System MicroRNAs Differentially Found in Colostrum and Milk Exosomes.

BACKGROUND: The fetus grows in a sterile womb environment. After birth, the newborn immune system has two immediate hurdles to clear. First immediate suppression of the womb compatible immune system and turn on the immune system of the newborn that can counter the antigenic world. The underlying mechanism of immune fluctuation by milk microRNAs (miRNAs) can be crucial for the treatment of critical or premature newborn. METHODS: We collected fourteen samples of each colostrum and mature milk from lactating mothers, four samples of each were used for microarray analysis, and the other ten were used for miRNA expression profiling by real-time PCR. RESULTS: From the microarray, 154 differentially expressed miRNAs were identified, whereas 49 miRNAs were revealed as immune-related miRNAs based on a literature study. Among the 49 miRNAs, 33 were already shown as strongly validated immune-related miRNAs (validated by qPCR, Western Blot, and Luciferase assay) and were considered for further analysis. Twenty-two miRNA expressions were analysed by real-time PCR as their Ct values were within considerable limits. Twelve numbers of miRNAs were significantly downregulated in mature milk compared to colostrum, which were again subjected to bioinformatics analysis to predict the biological mechanisms behind the differentially expressed miRNAs. CONCLUSION: This study shed light on the human milk exosome miRNA expression dynamics during lactation and their possible role in the gradual skewing of the newborns' immune system. The information is crucial for the development and onset of sepsis in premature newborns in the NICU.

Burden of congenital rubella syndrome (CRS) in India based on data from cross-sectional serosurveys, 2017 and 2019-20.

BACKGROUND: India has set a goal to eliminate measles and rubella/Congenital Rubella Syndrome (CRS) by 2023. Towards this goal, India conducted nationwide supplementary immunization activity (SIA) with measles-rubella containing vaccine (MRCV) targeting children aged between 9 months to <15 years and established a hospital-based sentinel surveillance for CRS. Reliable data about incidence of CRS is necessary to monitor progress towards the elimination goal. METHODS: We conducted serosurveys in 2019-20 among pregnant women attending antenatal clinics of 6 hospitals, which were also sentinel sites for CRS surveillance, to estimate the prevalence of IgG antibodies against rubella. We systematically sampled 1800 women attending antenatal clinics and tested their sera for IgG antibodies against rubella. We used rubella seroprevalence data from the current survey and the survey conducted in 2017 among antenatal women from another 6 CRS surveillance sites to construct a catalytic models to estimate the incidence and burden of CRS. RESULT: The seroprevalence of rubella antibodies was 82.3% (95% CI: 80.4-84.0). Rubella seropositivity did not differ by age group and educational status. Based on the constant and age-dependent force of infection models, we estimated that the annual incidence of CRS in India was 225.58 per 100,000 live births (95% CI: 217.49-232.41) and 65.47 per 100,000 live births (95% CI: 41.60-104.16) respectively. This translated to an estimated 14,520 (95% CI: 9,225-23,100) and 50,028 (95% CI: 48,234-51,543) infants with CRS every year based on age-dependent and constant force of infection models respectively. CONCLUSIONS: Our findings indicated that about one fifth of women in the reproductive age group in India were susceptible for rubella. The estimates of CRS incidence will serve as a baseline to monitor the impact of MRCV SIAs, as well progress towards the elimination goal of rubella/CRS.

Predictors of posterior reversible encephalopathy syndrome in women with hypertension in pregnancy: A prospective observational study.

OBJECTIVES: Posterior reversible encephalopathy syndrome (PRES) is a clinical neuro-radiologic abnormality associated with eclampsia and is diagnosed with magnetic resonance imaging (MRI). However, MRI scans to detect PRES may be difficult to obtain routinely. Thus, it would be useful to see whether standard demographic, clinical and laboratory parameters are predictive of PRES. STUDY DESIGN: Prospective observational cohort study. MAIN OUTCOME MEASURE: Prediction of PRES with standard parameters. RESULTS: 30 hypertensive pregnant women were enrolled. Brain MRI scans were performed after delivery till 7 days post-partum. Area under curves (AUC)s for clinical and laboratory parameters were generated for PRES prediction. A total of 8 women (5 with eclampsia and 3 with preeclampsia with features of severity) had PRES features in MRI. The most specific parameters for predicting PRES were age (<24 years), platelet count (<0.69 lacs/mm3), serum ALT (>129 IU/L) and AST (>55 IU/L), total bilirubin (>1.3 mg/dl), low hemoglobin (<8.7 g/dl) and presence of seizures. The most sensitive predicting parameters were serum uric acid > 5.2 mg/dl, systolic blood pressure (SBP) > 164 mm Hg, diastolic blood pressure > 100 mmHg and serum creatinine > 0.8 mg/dl. The best AUCs > 70% and good Youden indices were obtained for age < 24 years, SBP > 164 mm Hg, total bilirubin > 1.3 mg/dl, AST > 55 IU/L, hemoglobin < 8.7 mg/dl and uric acid > 5.2 mg/dl. CONCLUSION: In women with preeclampsia, younger age, raised SBP, elevated serum total bilirubin, uric acid and AST and low hemoglobin best predict PRES.

Cecal dermoid masquerading dermoid cyst of ovary: a case report and review of the literature.

BACKGROUND: The ovary is the most common site of occurrence of mature cystic teratomas (dermoid cysts). These are the most common ovarian germ cell tumor in the reproductive age group, accounting for 10-20% of all ovarian neoplasms, with a 1-2% risk of malignancy. A cecal dermoid cyst is a rare entity with only ten cases having been reported so far, eight of which could be retrieved as the rest were reported in different languages. None of these cases were managed laparoscopically. Here we present the first case of cecal dermoid managed laparoscopically. CASE PRESENTATION: A 35-year-old nulliparous Indian Hindu woman presented with complaints of on and off abdominal pain for 10 months. The abdominal examination revealed a well-defined mass of about 10 × 5 cm size, palpable in the right iliac fossa. On sonography, it was suggestive of a right-sided ovarian dermoid cyst. The lesion measured 10 × 7 × 5 cm on a contrast-enhanced computed tomogram (CT) scan. It was well defined and hypodense and located in the right lower abdomen. The ovarian tumor markers were normal. On laparoscopy, the uterus, bilateral tubes, and ovaries were found to be healthy. The cyst was seen arising from the right medial wall of the cecum at the ileocecal junction, which was excised laparoscopically. Histopathological study revealed it to be a mature cystic teratoma. CONCLUSION: Ovarian mature cystic teratoma commonly has an indolent course and can present with palpable abdominal mass, pain, or vomiting due to complications like torsion, hemorrhage, or infection. Alternatively, these cysts can be asymptomatic and incidentally detected. Clinicians should be aware of the variety of presentations of dermoid cysts of the bowel as well as mesentery. The exact location of the teratoma eluded us till the laparoscopy despite adequate imaging including a contrast-enhanced CT scan having been performed preoperatively. We are reporting this as it is a rare entity, and this knowledge will help gynecologists and surgeons make an appropriate surgical decision.

Serum Lysyl Oxidase Levels and Lysyl Oxidase Gene Polymorphism in Ovarian Cancer Patients of Eastern Indian Population.

(1) Background: Lysyl oxidase (LOX) plays a dual role in carcinogenesis and studies show a higher risk of cancer in LOX G473A variants. The present study evaluated the pattern of LOX G473A polymorphism (rs1800449) and serum LOX levels in ovarian cancer patients. (2) Methods: Serum LOX levels were estimated by enzyme linked immunosorbent assay (ELISA). A polymorphism of rs1800449 of LOX gene was detected by the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method. Selected samples were sequenced for external validation. (3) Results: A majority of study participants were from low socio-economic status. Serum LOX level was significantly higher in ovarian cancer patients as compared to control. Serum LOX level in early-stage ovarian cancer was significantly lower as compared to advanced stage (FIGO stage III & IV). Wild type GG genotype was used as reference. Genotypes AA were associated with a significant risk of epithelial ovarian cancer (OR 3.208; p value- 0.033). A allele of rs1800449 polymorphism of LOX gene, the odds ratio was 1.866 (95% Confidence Interval 1.112-3.16) p value = 0.017 (4) Conclusions: A allele of rs1800449 polymorphism of LOX gene presents an increased risk of ovarian cancer in East Indian population. Serum LOX levels could be a potential biomarker for the diagnosis and prognosis of ovarian cancer.

Awareness and opinion about polycystic ovarian syndrome (PCOS) among young women: a developing country perspective.

OBJECTIVE: To explore the perception on PCOS and its prevalence among adolescent and young women. METHODS: The study was conducted over 2 year period in a tertiary care teaching hospital from Eastern India. A pre-formed, validated questionnaire was used to record the details. Descriptive statistics was used to report the findings. RESULTS: Of 965 young patients with mean (SD) age 20.64 (2.1) years, 27 (2.79 %) were aware of an entity called PCOS. Awareness among adolescents with PCOS was 25.9 % (7/27). All aware patients belonged to the urban sector with professionals constituting around 48%, of which 11% were students. The major source of information among aware patients was from doctors (40.7%), and friends and Internet (25.9%); rest being from books, newspapers, and teachers. Majority (70%) were aware that diet restriction and exercise were the primary modalities of treatment, whereas, only 3.7% knew about the role of contraceptive pills in PCOS. CONCLUSIONS: Awareness regarding PCOS among the young women is very low mainly in the rural set up. Doctors and health staffs should play a major role in spreading awareness of the entity to prevent long term complications.

Prevalence and risk factors of obstetric fistula: implementation of a need-based preventive action plan in a South-eastern rural community of India.

BACKGROUND: The study was conducted to estimate the prevalence and risk factors of obstetric fistula in the rural area of the south eastern community of India and the training of community health workers for its prevention. METHODS: A population-based cross-sectional analytical study was conducted in the south eastern rural community of India. A total of 3939 women were included in the study and Probability proportional to size sampling was used in the study. Frequency distribution and logistic regression were computed to analyse the data using STATA version 11.2. RESULTS: Out of 3939 participants interviewed, 23.7% women reported obstetric fistula symptoms whereas after clinical diagnosis and speculum examination the obstetric morbidity pattern was: Obstetric fistula 0.3%, stress urinary incontinence 20.0%, pelvic inflammatory diseases 1.2%, uterine prolapse 1.4% and urinary tract infection 3.8%. The awareness level of the rural women regarding the obstetric fistula was assessed by a structured knowledge questionnaire and found to be very poor, hence community based fistula training was implemented among community health workers as a health system based strategy for its prevention. Obstetric fistula found to be more prevalent among women of poor educational level, low socioeconomic status, less no of antenatal visits, delay in accessing the emergency obstetric care and prolonged labour (p ≤ 0.05). CONCLUSION: Finding of the study indicated that the prevalence and risk of developing obstetric fistula was associated with less number of antenatal visits, prolonged labour, delay in timely intervention, delay in accessing emergency obstetric care and more number of movements from home to the delivery place. Finally, our study suggests that emphasis needs to be placed on training of community health workers to facilitate early screening for identification and referral of women with obstetric fistula.

Impact of Community-Based Continuous Training on Promoting Birth Preparedness and Pregnancy Outcome in Rural Odisha, India: An Interventional Study.

BACKGROUND: Birth preparedness and complication readiness extends the maternal and neonatal health continuum of care and thus contributes to one of the important tools for pregnant women to experience better pregnancy outcome, strengthening family and community health, creating space for other interventions. The present study aimed to evaluate community-based birth preparedness and complication readiness training on pregnancy outcome. METHOD: The study adopted a quasi-experimental time series only one experimental design which was conducted in rural south-eastern India for 1 year among the reproductive age group 15-49 years (≤ 24 weeks pregnancy), and cases were followed up till postnatal period. A standardized birth preparedness assessment index (BPAI) was used to assess preparedness level of respondents. Community-based continuous training (CBCT) was introduced, and its effect was measured on birth preparedness level, involvement of family and their pregnancy outcomes. RESULT: CBCT interventional program was effective in promoting positive behaviors on birth preparedness and complication readiness as per BPAI: 13% of women were at level 1, 15% at level 2, 19% at level 3, 49% participants were at 4th level and 5% were at 5th level which represented the best level of preparedness for their present delivery. Pregnant mothers who completed their antenatal visits and were well prepared for delivery were found to be having two times favorable pregnancy outcome than those who had not (OR 2.79). CONCLUSION: BPCR intervention strategy can be utilized as a timely and effective community action plan for ensuring a favorable pregnancy outcome.

Obstetric fistula: A challenge to public health.

Obstetric fistula (OF) is one of the most important consequences of a prolonged obstructed labor, a big issue for low-income countries (LICs) like India. The objective is to identify and explore the knowledge regarding OF as a public health problem in LICs from peer review literature. The PubMed, Google Scholar, and Science Direct databases were searched to identify the prevalence, risk factors, and management of OF in LICs. Quantitative evidence-based paper reviewed. Twenty-seven articles met the inclusion criteria. The 15 provided population-based OF prevalence data of OF and 12 provided risk factors and social causes of OF rates associated with the birth that caused an OF. OF has one of the big public health problems. There is a lack of scientific research on the prevalence and risk factors of OF in LICs. This review helps to eradicate or alleviate the problem of OF in LICs like India.

Lipoleiomyoma of the left broad ligament with dermoid cyst in ipsilateral ovary and synchronous multiple benign lesions of female genital tract: An unusual association.

Lipoleiomyoma of the uterus is a rare variant of leiomyoma, and lipoleiomyoma of the broad ligament is still rarer, with only a handful of cases being reported. The present case was a perimenopausal woman who presented with a huge lower abdominal mass. Ultrasonography and computed tomography showed a heterogeneous solid mass in the left adnexa. The histopathological findings confirmed the nature of the lesions as a benign lipoleiomyoma with dermoid cyst of the left ovary and its other associated benign lesions, were the interesting features seen in this case which were not suspected clinically and radiologically.

Bilateral Simultaneous Tubal Ectopic Pregnancy: A Case Report, Review of Literature and a Proposed Management Algorithm.

Bilateral simultaneous Tubal Ectopic Pregnancy (BTP) is the rarest form of ectopic pregnancy. The incidence is higher in women undergoing assisted reproductive techniques or ovulation induction. The clinical presentation is unpredictable and there are no unique features to distinguish it from unilateral ectopic pregnancy. BTP continues to be a clinician's dilemma as pre-operative diagnosis is difficult and is commonly made during surgery. Treatment options are varied depending on site of ectopic pregnancy, extent of tubal damage and requirement of future fertility. We report a case of BTP which was diagnosed during surgery and propose an algorithm for management of such patients.

Uterine Fibroid (Leiomyoma) with Acute Urinary Retention: A Case Series.

Uterine leiomyomas are an extremely rare cause of acute urinary retention in women. The delay in diagnosing uterine leiomyomas presenting with acute urinary retention further complicates the management. The rarity of the condition makes it difficult to plan either prospective or retrospective trials. Hence, most of the evidence comes from case reports or series. We report a case series of acute urinary retention in women with uterine leiomyomas and discuss the pathophysiology, diagnosis and management options.

Bilateral Serous Psammocarcinoma of Ovary: Rare Variant Low Grade Serous Carcinoma.

Serous psammocarcinoma is a rare variant of serous carcinoma arising from either ovary or peritoneum, characterized by massive psammoma body formation, low grade cytologic features, and invasiveness. Its clinical behavior is similar to serous borderline tumors with relatively favorable prognosis. We report herein a case of a 60-year-old postmenopausal woman who presented with abdominal distension. Contrast enhanced computed tomography (CECT) revealed calcified pelvic masses with ascites. Elevated serum CA-125 (970 U/mL) suggested malignant ovarian neoplasm. Patient underwent exploratory laparotomy with primary debulking surgery. Histopathology showed bilateral serous psammocarcinoma of ovary with invasive implants on omentum. Adjuvant chemotherapy was advised in view of advanced stage disease, although its benefits are poorly defined due to rarity of the tumor. However, patient opted out of it and is now on follow-up.