Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

OBJECTIVE: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. METHODS: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. RESULTS: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. CONCLUSIONS: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.

Thoracotomy Patients Under General Anesthesia: A Comparison on Intra-Operative Anesthetic and Analgesic Requirements, When Combined with Either Epidural Analgesia or Continuous Unilateral Paravertebral Analgesia.

BACKGROUND AND OBJECTIVE: Regional analgesia is effective for post-thoracotomy pain. The primary objective of the study is to compare the intraoperative requirement of isoflurane and fentanyl between general anaesthesia (GA) with epidural analgesia and GA with paravertebral analgesia. METHODS AND MATERIAL: A prospective observational comparative study was conducted on 56 patients undergoing open thoracotomy procedures. The patients were divided into two groups of 28 by assigning the study participants alternatively to each group: Group GAE - received thoracic epidural catheterization with GA, and Group GAP - received ultrasound guided thoracic paravertebral catheterization on the operative side with GA. Intraoperative requirement of isoflurane, fentanyl, postoperative analgesia, stress response, need of rescue analgesics and adverse effects were observed and analysed. RESULTS: 25 patients in each group were included in the data analysis. The intraoperative requirement of isoflurane (32.28 ± 1.88 vs 48.31 ± 4.34 ml; p < 0.0001) and fentanyl (128.87 ± 25.12 vs 157 ± 30.92 µg; p = 0.0009) were significantly less in the GAE group than in the GAP group. VAS scores and need of rescue analgesics and blood glucose levels were not statistically significant during the postoperative period (p > 0.05). The incidence of adverse effects was comparable except for hypotension and urinary retention which were significantly higher in the GAE group. CONCLUSION: GA with epidural analgesia resulted in significant reduction in the intraoperative consumption of isoflurane and fentanyl in comparison to GA with paravertebral analgesia. However, both the techniques were equally effective in the postoperative period.

Mental health issues in antenatal women with prior adverse pregnancy outcomes: Unmasking the mental anguish of rainbow pregnancy.

Background & objectives: Mental health issues in pregnancy have adverse implications on the quality of life, however still they go unevaluated and underreported. Women with previous history of abortions or stillbirth may have a higher risk of experiencing mental health problems. The present investigation was aimed to study the prevalence of depression, anxiety, stress and domestic violence in antenatal women with prior pregnancy losses and the need for interventions to treat the same. Methods: One hundred pregnant women with a history of prior pregnancy losses (group 1) and 100 women without obstetrical losses (group 2) were enrolled in this cross-sectional study carried out in a tertiary care hospital in India. Women were screened for depression, anxiety, stress and domestic violence using various questionnaires: EPDS (Edinburgh postnatal depression scale), PRAQ-2 (pregnancy-related anxiety questionnaire-revised 2), GAD 7 (generalized anxiety disorder-7) and PSS (perceived stress scale). Results: The prevalence of depression (EPDS scale) and pregnancy specific anxiety (PRAQ-2 scale) was significantly higher in group 1 than in group 2 (27 vs. 10%, P=0.008; and 15 vs. 6%, P=0.03). The prevalence of general anxiety (GAD 7 scale) and stress (PSS), however, was high and comparable in both the groups (33 vs. 29%, P=0.44; and 33 vs. 27%; P=0.35 respectively). Recurrent abortions was found to be an independent risk factor for depression [adjusted odds ratio=26.45; OR=28]. In group 1, 31 per cent required counselling in the psychiatry department and nine per cent required medication. Interpretation & conclusion: Mental health issues, especially depression, are prevalent in antenatal women with previous losses. Unrecognised and untreated, there is a need for counselling and developing screening protocols at India's societal and institutional levels.

Efficacy of zoledronate, denosumab or teriparatide in postmenopausal women with type 2 diabetes mellitus at high risk of fragility fractures: protocol of an open, blinded endpoint randomized controlled pilot trial.

Background: People with type 2 diabetes (T2D) are at high risk of fragility fractures; however, there are no randomized controlled trials evaluating the efficacy of anti-osteoporosis drugs as a primary pre-specified endpoint in T2D. Objectives: To compare the efficacy of anti-osteoporotic drugs in postmenopausal women with T2D. Design: Prospective, randomized, open, blinded endpoint clinical pilot trial. Methods: Postmenopausal women (⩾50 years) with T2D (duration ⩾5 years), HbA1c 7-10%, eGFR ⩾45 mL/min/1.73 m2 and prior vertebral (clinical/morphometric), hip, radius, humeral fragility fracture or bone mineral density (BMD) T-score (adjusted for diabetes) at lumbar spine/femoral neck ⩽-2.5 and high FRAX score will be eligible for inclusion. Subjects with secondary causes of osteoporosis, prior exposure to bone-active therapies or history of use of glucocorticoids/pioglitazone/thiazides/canagliflozin will be excluded. Finally, eligible subjects will undergo estimation of serum calcium, phosphate, alkaline phosphatase, parathyroid hormone, 25-hydroxyvitamin D and bone turnover markers (BTMs) (total procollagen type I N-propeptide, ß-CTX) along with trabecular bone score (TBS) and high-resolution peripheral quantitative computed tomography (HR-pQCT) of non-dominant hand and leg. After a 2-week run in phase, they will be randomized in a 1:1:1:1 ratio to receive yearly zoledronate, or biannually denosumab or daily teriparatide (in addition to standard of care, i.e., calcium 1000 mg/day and cholecalciferol 1000 IU/day) or only standard of care (control). The primary endpoints will be change in areal BMD and frequency of incident fractures at 18 months. The secondary endpoints will be change in HR-pQCT parameters, TBS and BTMs at 18 months. Adverse events will be recorded for all randomized participants. Ethics: The study has been approved by the Institute Ethics Committee. Written informed consent will be obtained from each participant. Discussion: The trial is expected to provide information regarding optimal anti-osteoporotic therapy in people with T2D and bone fragility. Registration: Prospectively registered in Clinical Trial Registry of India (CTRI/2022/02/039978).

Stillbirths in India: Current Status, Challenges, and the Way Forward.

Stillbirth is a major public health challenge and a multifaceted issue that leads to significant financial, physical, mental, financial, and psychosocial implications. India has made substantial progress in stillbirth reduction. Yet, many challenges continue and the absolute number of stillbirths remain high. This paper presents the national and state level burden of stillbirths and discusses about the magnitude, risk factors, causes and inequities in stillbirths. A few additional approaches for reduction of preventable stillbirths have been suggested. The authors argue that the institutional mechanisms need to be developed to ensure all stillbirths are registered in a timely manner. There is a need for standard definition for classification of stillbirths and document the cause, to roll-out suitable interventions. There is a need for state specific interventions to address different causes, as Indian states have variable stillbirth rates. The stillbirth audits should be institutionalised as a continuous quality improvement exercise to bring local accountability and reduce stillbirth rate. The healthcare system and providers must be trained to offer bereavement support to the affected mothers and families. These approaches should be implemented through primary healthcare system as well.

Burden, Differentials and Causes of Stillbirths in India: A Systematic Review and Meta Analysis.

India contributes the highest absolute number of stillbirths in the world. This systematic review and meta-analysis was conducted to synthesize the burden, timing and causes of stillbirths in India. Forty-nine reports from 46 studies conducted in 21 Indian states and Union Territories were included. It was found that there was no uniformity/standardization in the definition of stillbirths and in the classification system used to assign the cause. The share of antepartum stillbirths was estimated to be two-third while remaining were intrapartum stillbirths. Maternal conditions and fetal causes were found to be the leading cause of stillbirth in India. The maternal condition was assigned as the commonest cause (25%) followed by fetal (14%), placental cause (13%), congenital malformation (6%) and intrapartum complications (4%). Approximately 20% of the stillbirths were assigned as unknown or unexplained. This review demonstrates that there is a paucity of quality stillbirth data in India. Other than the state level differences in stillbirth rates, no other data is available on inequities in stillbirths in India. There is an urgent need for strengthening availability and quality of stillbirth data in India on both stillbirth rates as well as the causes. There is a need to conduct additional research to know the timing of the stillbirths, causes of death and actual burden. India needs to strengthen stillbirth audits along with registry to find out the modifiable factors and delays for making country specific preventive strategies. The policy makers, academic community and researchers need to work together to ensure accelerated and equitable reduction in stillbirths in India.

Successful in vitro fertilization following conservative surgery for synchronous endometrioid tumor of ovary and uterus.

BACKGROUND: Successful pregnancy outcome in women with synchronous ovarian and endometrial cancers is very rare. We report successful pregnancy outcome in a young woman managed conservatively for synchronous endometrial and ovarian cancer. CASE PRESENTATION: Thirty years old nulliparous lady presented following exploratory laparotomy, left salpingo-oophorectomy and hysteroscopic polypectomy for left adnexal mass. Histology revealed endometrioid carcinoma of left ovary and moderately differentiated adenocarcinoma in the resected polyp. She underwent staging laparotomy along with hysteroscopy which confirmed above findings without any evidence of further tumor spread. She was treated conservatively with high dose oral progestin (megestrol acetate, 160 mg) and leuprolide acetate 3.75 mg monthly injections for three months along with four cycles of carboplatin and paclitaxel based chemotherapy followed by monthly injection of leuprolide for further three months. After failure of spontaneous conception, she underwent ovulation induction for six cycles along with intrauterine insemination which failed. She underwent in vitro fertilization with donor egg followed by elective cesarean section at 37 weeks of gestation. She delivered a healthy baby of weight 2.7 kg. Intraoperatively 5 × 6 cm right ovarian cyst was found which drained chocolate coloured fluid on puncture and cystectomy was carried out. Histological examination revealed endometrioid cyst of right ovary. Uterus was spared as she wanted to preserve her fertility. She is being followed periodically and is normal nine months following delivery. She is on injection Depot medroxy progesterone acetate once every three months.

Legal Limits Relaxed: Time to Look at Other Barriers Faced by Women Seeking Termination of Pregnancy for Fetal Anomalies.

Introduction Advancements in prenatal diagnostic techniques have led to an increase in demand for termination of pregnancy for fetal anomalies (TOPFA). While relaxation in the legal gestational age limits across various countries relieves an important barrier, there is a need to identify the reasons that lead to delays in seeking abortion for fetal anomalies, because abortion-related complications increase with gestational age. Methods In this hospital-based qualitative study, antenatal women referred to a tertiary care institute in North India because of major fetal anomalies were explained about the study. Those women who fulfilled the inclusion criteria were recruited after taking consent. Details of antenatal care and prenatal tests were recorded. An in-depth inquiry was made into the reasons for the delay in prenatal tests, the delay in the decision for abortion, and specific problems that they faced in seeking TOPFA. Results Out of 80 women who met the inclusion criteria and consented to participate, more than 75% had received antenatal care in public healthcare facilities. Less than 50% of women received folic acid in the first trimester while 26% had first contact with healthcare facilities in the second trimester. Only 21 women underwent screening for common aneuploidies. Second-trimester anomaly scan was delayed in 35 women due to women-centered reasons (n = 17) or provider-centered (n = 19) reasons. Only 37.5% of women were counseled about fetal anomalies by their primary care provider. Owing to delay at multiple levels, 40 women (50%) could receive counseling about fetal abnormality for the first time after 20 weeks. These women could not be offered abortion because this study was carried out before the amendments in the Medical Termination of Pregnancy Act in India. The older act allowed abortion up to 20 weeks of gestation. Seventeen women could obtain permission for an abortion from a court of law. Arrangements for travel and stay and dependence on family members were the main problems faced by women seeking TOPFA. Conclusions Delay in diagnosis of a fetal anomaly due to delay in seeking antenatal care, irregular follow-up, and lack of pre-test counseling are the major reasons for the delay in the decision for abortion. This is further compounded by inadequate post-test counseling. Lack of awareness, failure or delay in counseling, need to travel to another facility for abortion, dependence on family members, and financial issues are the major barriers.

Challenges and outcomes of pregnancy in an uncorrected Tetralogy of Fallot with pulmonary atresia and major aorta-pulmonary collateral arteries (MAPCA): a case report.

BACKGROUND: Tetralogy of Fallot is a severe type of congenital heart disease (CHD) and one of the leading indirect causes of mortality & morbidity among women with CHD. We came across a rare case of an uncorrected Tetralogy of Fallot with pulmonary atresia and major aortopulmonary collateral arteries in pregnancy. CASE PRESENTATION: We are reporting the challenges in managing a pregnancy of 25-years-old G3 P0110, previous one stillbirth and who was diagnosed to have congenital heart disease during pregnancy following spontaneous abortion. CONCLUSIONS: This case report highlights the role of multidisciplinary care in managing such a high risk case. It also emphasizes the role of cardiac examination of every woman before pregnancy so that definitive treatment or optimization can be done in time for a better outcome.

Pregnancy in Eisenmenger syndrome: a case series from a tertiary care hospital of Northern India.

BACKGROUND: Despite advances in medical care, we still come across pregnancy in Eisenmenger syndrome. Eisenmenger syndrome represents the severe end of the spectrum for disease in pulmonary artery hypertension associated with CHD. Due to very high maternal and perinatal morbidity and mortality, pregnancy is contraindicated among these women. Current guidelines also recommend that the women who become pregnant should opt for early termination of pregnancy. Here, we present a case series of 11 women of Eisenmenger syndrome and their pregnancy outcome. METHODS: It was a retrospective analysis of 12 pregnancies among 11 women with Eisenmenger syndrome who were managed in a tertiary care referral centre of Northern India. RESULTS: The mean age of these women was 28 ± 4 years (range 22 to 36 years). Almost 80% of them (9/11) were diagnosed with Eisenmenger syndrome during pregnancy. The commonest cardiac lesion was Ventricular Septal defect (54.5%) followed by Atrial Septal defect (27.3%) and Patent Ductus arteriosus (9.1%). Only three women opted for medical termination of pregnancy, rest eight continued the pregnancy or presented late. Pregnancy complications found include pre-eclampsia (50%), abruption (22%), and fetal growth retardation (62.5%). There were three maternal deaths (mortality rate 27%) in postpartum period. CONCLUSION: This case series highlights the delay in diagnosis and treatment of CHD despite improvement in medical care. Women with Eisenmenger syndrome require effective contraception, preconceptional counselling, early termination of pregnancy, and multidisciplinary care.

Hypertrophic Cardiomyopathy and Pregnancy: A Retrospective Analysis From a Tertiary Care Hospital.

Pregnancy in women with hypertrophic cardiomyopathy is not well described. In this retrospective study, we analyzed data on pregnant women with hypertrophic cardiomyopathy who were under follow-up care in the cardiology department of a tertiary care hospital. We reviewed data on all women registered in the hypertrophic cardiomyopathy cohort and those who attended the cardio-obstetric clinic and delivered between January 2010 and June 2019. From these 2 groups, we identified 7 pregnant women with hypertrophic cardiomyopathy who delivered during this period. These 7 women (mean [SD] age, 25 [3.3] years) had a total of 15 pregnancies (range per woman,1-4). This was a high-risk cohort, as 7 (46.7%) pregnancies were in the modified World Health Organization class III. The mean (SD) left ventricular wall thickness was 19.71 (2.56) mm in all pregnancies. Two of the 7 women with left ventricular outflow tract obstruction developed severe symptoms in the third trimester; these improved soon after delivery. Eight pregnancies without obstruction were well tolerated. Two pregnancies occurred after successful alcohol septal ablation. Both remained asymptomatic throughout pregnancy. All women tolerated labor well. Adverse maternal outcomes, including death, were not seen in any patient. All women who became symptomatic during pregnancy had relief of symptoms after delivery. Most women remained asymptomatic or had mild symptoms during pregnancy. Of the women with left ventricular outflow tract obstruction, 28.6% had severe symptoms that improved after delivery. Pregnancy was well tolerated after successful alcohol septal ablation.

Maternal and Fetal Outcomes Following Percutaneous Transluminal Mitral Commissurotomy in Pregnant Women with Critical Mitral Stenosis: An Experience of a Tertiary Care Center from Northern India.

BACKGROUND: Rheumatic mitral stenosis is the common valvular heart disease seen during pregnancy. Percutaneous transvenous mitral commissurotomy is an effective, safe, and recommended treatment for critical mitral stenosis during pregnancy. We hereby report the maternal and fetal outcomes of pregnant women subjected to percutaneous trans- venous mitral commissurotomy at our institute. METHODS: Seventy consecutive pregnant women with critical mitral stenosis, who under- went PTMC during the last 10 years, were retrospectively analyzed. All patients had a detailed clinical and obstetric evaluation and were optimally managed with drugs, before the intervention. A comprehensive pre- and post-percutaneous transvenous mitral commissurotomy transthoracic echocardiographic evaluation was performed. Detailed obstetric and fetal outcomes were noted at the time of delivery. Six weeks of post-partum follow-up was noted in all patients. RESULTS: The mean gestational age at the time of percutaneous transvenous mitral com- missurotomy was 29.5 ± 6.68 weeks. Percutaneous transvenous mitral commissurotomy was successful in 97% of patients. Post-percutaneous transvenous mitral commissurot- omy New York Heart Association functional class, mitral valve area, trans-mitral pres-sure gradient, and left atrial pressure had a significant improvement (P < .001). The mean gestational age at the time of delivery was 36.92 ± 3.02 weeks. The mean birth weight of live newborn was 2.29 ± 0.55 kg. The fetal complications include growth restriction in 62.85%, preterm delivery in 34.37%, and low birth weight in 67.21%. A delayed percutane- ous transvenous mitral commissurotomy at about 30 weeks of gestation did not affect the maternal and fetal outcomes. CONCLUSION: Percutaneous transvenous mitral commissurotomy is safe and efficacious in managing pregnant women with critical mitral stenosis. There was a significant improve- ment in clinical symptoms and echocardiographic parameters following percutaneous transvenous mitral commissurotomy.

A randomized controlled trial to compare antibiotic prophylaxis in elective gynecological surgeries: Single dose of cefazolin versus single dose of cefazolin and tinidazole.

Objectives: To evaluate if addition of an anti-anaerobic agent to standard drug-cefazolin for antimicrobial prophylaxis would further decrease postoperative infectious morbidity or not. This is relevant as most of the infections in gynecological surgeries are anaerobic but cefazolin does not protect against anaerobes. Materials and Methods: The study design was a parallel randomized controlled trial. Two hundred patients undergoing benign gynecological surgeries were divided into two groups of 100 each. Group A received 2 g cefazolin 30-60 min before incision and Group B received 2 g cefazolin 30-60 min and 1.6 g tinidazole 60-120 min before incision. The patients were followed for any infectious morbidity for 1 month postoperatively. The analysis was done separately for abdominal, laparoscopic, and vaginal surgeries. The analysis was also done for surgeries according to the wound category, i.e. clean and clean-contaminated. Results: The two groups were comparable for age and body mass index (BMI). The two groups were comparable for the factors affecting infectious morbidity such as duration of surgery, blood loss, blood transfusions, duration of hospital stay, and need for additional antibiotics. The postoperative infectious morbidity was analyzed in terms of fever, surgical site infection (SSI), and urinary tract infection (UTI). No patient in vaginal and laparoscopic groups suffered from infectious morbidity. In abdominal surgeries group, postoperative fever occurred in 6/74 (8.1%) and 11/74 patients (14.8%) in Groups A and B, respectively (P = 0.38). SSI occurred in 1/74 (1.3%) and 2/74 (2.7%) patients in Groups A and B, respectively (P = 1.0). UTI occurred in 5/74 patients (6.7%) and 2/74 patients (2.7%) in Groups A and B, respectively (P = 0.44). The data were also analyzed for infectious morbidity for clean and clean-contaminated wound categories, and the results were nonsignificant between both groups for each type of wound category (P > 0.05). Conclusion: Cefazolin alone is a sufficient antibiotic prophylaxis for benign gynecological procedures.

Bereavement Care Practices Following Stillbirths: Health-Care Provider's Perspective.

Background: Addressing stillbirth is a difficult task and becomes more challenging with a huge burden and skewed doctorpatient ratio. There is a lack of data regarding the knowledge about the bereavement care practices following pregnancy loss and practices being followed by the health-care providers in the Indian context. The objective of this study is to describe the experience, views, and practices of health-care professionals while managing women with stillbirths. Design: Internet-based Monkey Survey. Methodology: An on-line self completion questionnaire was shared with various health care providers via emails and whats app groups. Results: A total of 281 responses of health-care providers were analyzed, and the majority of them were obstetricians. Almost 90% had managed women with stillbirth, but just a third (38.1%) had provided bereavement care. The majority of them felt the lack of a uniform and comprehensive training model for providing bereavement care to such women. Out of 281 participants, 258 (91.8%) believed that health-care providers should have a bereavement care training and support system, whereas only 23 (8.2%) rejected this idea. Conclusion: There is no defined protocol or standards for providing bereavement care to women following stillbirth. Most health-care professionals feel an urgent need for professional training to bridge the gap between the expectations of patients and the care provided.

Baseline Assessment of Evidence-Based Intrapartum Care Practices in Medical Schools in 3 States in India: A Mixed-Methods Study.

INTRODUCTION: Implementation research with pre- and post-comparison was planned to improve the quality of evidence-based intrapartum care services in Indian medical schools. We present the baseline study results to assess the status of adherence to intrapartum evidence-based practices (IP-EBP) in study schools in 3 states in India and the perception of the faculty. METHODS: A concurrent mixed-methods approach was used to conduct the baseline assessment in 9 medical schools in Rajasthan, Gujarat, and Union Territory from October 2018 to June 2019. IP-EBP among pregnant women in uncomplicated first (n=135), second (n=120), and third stage (n=120) of labor were observed using a predesigned, pretested checklist quantitatively. We conducted in-depth interviews with 33 obstetrics and gynecology faculty to understand their perceptions of intrapartum practices. Quantitative data were analyzed using SPSS (version 22). COM-B (Capability, Opportunity, and Motivation Behavior) model was used to understand the behaviors, and thematic analysis was done for the qualitative data. FINDINGS: Unindicated augmentation of labor was done in 64.4%, fundal pressure applied in 50.8%, episiotomy done in 58.3%, and delivery in lithotomy position was performed in 86.7% of women in labor. CONCLUSIONS: Intrapartum practices that are not recommended were routinely practiced in the study medical schools due to a lack of staff awareness of evidence-based practices and incorrect beliefs about their impact.

Facility-based stillbirth surveillance review and response: an initiative towards reducing stillbirths in a tertiary care hospital of India.

OBJECTIVES: India has the highest number of stillbirths in the world in 2019, with an estimated stillbirth rate of 13.9 per 1,000 births. Towards better identification and documentation, a stillbirth surveillance pilot was initiated with the World Health Organization Southeast Asia collaboration in Northern India in 2014. This study aimed to assess whether stillbirth surveillance is feasible and whether this approach provides sufficient information to develop strategies for prevention. METHODS: This study followed the framework provided in "WHO Making Every Baby Count" in which mortality audit is conducted in six steps; (1) identifying cases; (2) collecting information; (3) analysis; (4) recommending solutions; (5) implementing solutions; and (6) evaluation. RESULTS: A total of 5,284 births were examined between December 2018 and November 2019; 266 stillbirths were identified, giving a stillbirth rate of 50.6 per 1,000 births in a tertiary care referral hospital of northern India. Out of 266 stillbirths, 223 cases were reviewed and recommendations were formulated to strengthen obstetric triage, implementing fetal growth charts, strengthen the existing referral system and improve the communication skills of health care providers for better compliance with clinical practice guidelines. CONCLUSIONS: Conducting stillbirth surveillance review and the response of cases in low-middle income countries setting is feasible. As countries progress towards ending preventable mortality, this has the potential to serve as a key process in improving evidence-based and context-specific planning and preventive strategies towards improving the quality of care.

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study).

INTRODUCTION: Stillbirth is associated with significant physical, psychosocial and economic consequences for parents, families, wider society and the healthcare system. There is emerging momentum to design and evaluate interventions for care after stillbirth and in subsequent pregnancies. However, there is insufficient evidence to inform clinical practice compounded by inconsistent outcome reporting in research studies. To address this paucity of evidence, we plan to develop a core outcome set for stillbirth care research, through an international consensus process with key stakeholders including parents, healthcare professionals and researchers. METHODS AND ANALYSIS: The development of this core outcome set will be divided into five distinct phases: (1) Identifying potential outcomes from a mixed-methods systematic review and analysis of interviews with parents who have experienced stillbirth; (2) Creating a comprehensive outcome long-list and piloting of a Delphi questionnaire using think-aloud interviews; (3) Choosing the most important outcomes by conducting an international two-round Delphi survey including high-income, middle-income and low-income countries; (4) Deciding the core outcome set by consensus meetings with key stakeholders and (5) Dissemination and promotion of the core outcome set. A parent and public involvement panel and international steering committee has been convened to coproduce every stage of the development of this core outcome set. ETHICS AND DISSEMINATION: Ethical approval for the qualitative interviews has been approved by Berkshire Ethics Committee REC Reference 12/SC/0495. Ethical approval for the think-aloud interviews, Delphi survey and consensus meetings has been awarded from the University of Bristol Faculty of Health Sciences Research Ethics Committee (Reference number: 116535). The dissemination strategy is being developed with the parent and public involvement panel and steering committee. Results will be published in peer-reviewed specialty journals, shared at national and international conferences and promoted through parent organisations and charities. PROSPERO REGISTRATION NUMBER: CRD42018087748.

The unheard parental cry of a stillbirth: fathers and mothers.

PURPOSE: Our objective was to compare the prevalence of depression, anxiety, stress, and domestic violence among parents after a stillbirth vs. livebirths and assessing of the need for psychological and pharmacological interventions for the affected individuals. METHODS: This was a prospective cohort study conducted in a tertiary care public sector hospital Northern India. 150 consecutive couples with a recent stillbirth (group 1) and 150 couples with a recent live birth (group 2) were enrolled. They were screened for depression (EPDS scale), anxiety (GAD-7), stress (PSS). Apriori sample size was calculated. Screen positive mothers and fathers were compared for the presence of depression, anxiety and stress, domestic violence, and need for treatment interventions. RESULTS: Depression was higher in group 1 mothers (39.3 vs 14.0%, p < 0.001) as well as fathers (18.1 vs 6.7%, p value = 0.022). Anxiety and moderate to severe stress were also significantly higher in stillborn than liveborn groups respectively. Characteristics associated with higher risk are analyzed. Domestic violence was found in 6.7% in group 1 and 2.7% in group 2 mothers (p value 0.169). Pharmacotherapy and counselling were required by 11.3 and 18.0% in stillbirth versus 3.3 and 18.7% in livebirth group, respectively. CONCLUSION: Couples suffering stillbirths are at higher risk of depression, anxiety, and stress. We highlight this obstetrical public health issue, especially for the low middle income countries (LMIC) and advocate development of health policies for mental health screening of couples suffering stillbirths.