Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

BACKGROUND: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).

Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth.

BACKGROUND: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. METHODS: We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 µg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. RESULTS: A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups. CONCLUSIONS: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).

Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation.

INTRODUCTION: The World Health Organization's (WHO) Labour Care Guide (LCG) is a "next-generation" partograph based on WHO's latest intrapartum care recommendations. It aims to optimize clinical care provided to women and their experience of care. We evaluated the LCG's usability, feasibility, and acceptability among maternity care practitioners in clinical settings. METHODS: Mixed-methods evaluation with doctors, midwives, and nurses in 12 health facilities across Argentina, India, Kenya, Malawi, Nigeria, and Tanzania. Purposively sampled and trained practitioners applied the LCG in low-risk women during labor and rated experiences, satisfaction, and usability. Practitioners were invited to focus group discussions (FGDs) to share experiences and perceptions of the LCG, which were subjected to framework analysis. RESULTS: One hundred and thirty-six practitioners applied the LCG in managing labor and birth of 1,226 low-risk women. The majority of women had a spontaneous vaginal birth (91.6%); two cases of intrapartum stillbirths (1.63 per 1000 births) occurred. Practitioner satisfaction with the LCG was high, and median usability score was 67.5%. Practitioners described the LCG as supporting precise and meticulous monitoring during labor, encouraging critical thinking in labor management, and improving the provision of woman-centered care. CONCLUSIONS: The LCG is feasible and acceptable to use across different clinical settings and can promote woman-centered care, though some design improvements would benefit usability. Implementing the LCG needs to be accompanied by training and supportive supervision, and strategies to promote an enabling environment (including updated policies on supportive care interventions, and ensuring essential equipment is available).

Feeding practices and growth patterns of moderately low birthweight infants in resource-limited settings: results from a multisite, longitudinal observational study.

OBJECTIVES: To describe the feeding profile of low birthweight (LBW) infants in the first half of infancy; and to examine growth patterns and early risk factors of poor 6-month growth outcomes. DESIGN: Prospective observational cohort study. SETTING AND PARTICIPANTS: Stable, moderately LBW (1.50 to <2.50 kg) infants were enrolled at birth from 12 secondary/tertiary facilities in India, Malawi and Tanzania and visited nine times over 6 months. VARIABLES OF INTEREST: Key variables of interest included birth weight, LBW type (combination of preterm/term status and size-for-gestational age at birth), lactation practices and support, feeding profile, birthweight regain by 2 weeks of age and poor 6-month growth outcomes. RESULTS: Between 13 September 2019 and 27 January 2021, 1114 infants were enrolled, comprising 4 LBW types. 363 (37.3%) infants initiated early breast feeding and 425 (43.8%) were exclusively breastfed to 6 months. 231 (22.3%) did not regain birthweight by 2 weeks; at 6 months, 280 (32.6%) were stunted, 222 (25.8%) underweight and 88 (10.2%) wasted. Preterm-small-for-gestational age (SGA) infants had 1.89 (95% CI 1.37 to 2.62) and 2.32 (95% CI 1.48 to 3.62) times greater risks of being stunted and underweight at 6 months compared with preterm-appropriate-for-gestational age (AGA) infants. Term-SGA infants had 2.33 (95% CI 1.77 to 3.08), 2.89 (95% CI 1.97 to 4.24) and 1.99 (95% CI 1.13 to 3.51) times higher risks of being stunted, underweight and wasted compared with preterm-AGA infants. Those not regaining their birthweight by 2 weeks had 1.51 (95% CI 1.23 to 1.85) and 1.55 (95% CI 1.21 to 1.99) times greater risks of being stunted and underweight compared with infants regaining. CONCLUSION: LBW type, particularly SGA regardless of preterm or term status, and lack of birthweight regain by 2 weeks are important risk identification parameters. Early interventions are needed that include optimal feeding support, action-oriented growth monitoring and understanding of the needs and growth patterns of SGA infants to enable appropriate weight gain and proactive management of vulnerable infants. TRIAL REGISTRATION NUMBER: NCT04002908.

Facility-based care for moderately low birthweight infants in India, Malawi, and Tanzania.

Globally, increasing rates of facility-based childbirth enable early intervention for small vulnerable newborns. We describe health system-level inputs, current feeding, and discharge practices for moderately low birthweight (MLBW) infants (1500-<2500g) in resource-constrained settings. The Low Birthweight Infant Feeding Exploration study is a mixed methods observational study in 12 secondary- and tertiary-level facilities in India, Malawi, and Tanzania. We analyzed data from baseline facility assessments and a prospective cohort of 148 MLBW infants from birth to discharge. Anthropometric measuring equipment (e.g., head circumference tapes, length boards), key medications (e.g., surfactant, parenteral nutrition), milk expression tools, and human milk alternatives (e.g., donor milk, formula) were not universally available. MLBW infants were preterm appropriate-for-gestational age (38.5%), preterm large-for-gestational age (3.4%), preterm small-for-gestational age (SGA) (11.5%), and term SGA (46.6%). The median length of stay was 3.1 days (IQR: 1.5, 5.7); 32.4% of infants were NICU-admitted and 67.6% were separated from mothers at least once. Exclusive breastfeeding was high (93.2%). Generalized group lactation support was provided; 81.8% of mother-infant dyads received at least one session and 56.1% had 2+ sessions. At the time of discharge, 5.1% of infants weighed >10% less than their birthweight; 18.8% of infants were discharged with weights below facility-specific policy [1800g in India, 1500g in Malawi, and 2000g in Tanzania]. Based on descriptive analysis, we found constraints in health system inputs which have the potential to hinder high quality care for MLBW infants. Targeted LBW-specific lactation support, discharge at appropriate weight, and access to feeding alternatives would position MLBW for successful feeding and growth post-discharge.

Demographic Profile, Etiology, and Perinatal Outcome Associated With Preterm Birth in a Tertiary Hospital of Eastern India: A Retrospective Study.

Background Preterm birth (PB), defined as birth occurring at less than 37 weeks of gestation, is a leading cause of perinatal mortality and morbidity in the world. Objectives This study aimed to evaluate the socio-demographic characteristics and etiological factors associated with preterm birth and consequent adverse perinatal outcomes retrospectively at a tertiary care hospital.  Methods A single-centre retrospective observational study was conducted in the department of Obstetrics & Gynaecology, Fakir Mohan Medical College & Hospital, Balasore, Odisha, India, from April 2019 to March 2020. Data were retrieved from the antenatal ward admission register, case files, theatre records, and neonatal care unit records and reviewed. Descriptive statistics were used to describe data. Chi-square test and student's t-test were used to find significance of difference between variables. Results The incidence of preterm birth in the study population was 5.52%. The mean gestational age of preterm deliveries was 34.39 ± 1.92 weeks. The bulk of the women hailed from a rural background and belonged to the lower socioeconomic strata. About 47.29% of the women were nulliparous and spontaneous preterm birth was noted in 70.40%. Premature rupture of membranes (PROM), anaemia, intrauterine growth restriction (IUGR), preeclampsia, and eclampsia were the most common adverse pregnancy conditions prevalent in these women. Preterm deliveries comprised 31.21% of all neonatal intensive care unit (NICU) admissions. Respiratory distress syndrome, birth asphyxia, neonatal sepsis, and jaundice were the most common complications. Neonatal death occurred in 51 (9.21%) preterm infants with birth asphyxia being the commonest cause of such deaths. Maternal factors and adverse neonatal outcome variables were compared between the spontaneous and iatrogenic/medically indicated preterm birth groups. Preeclampsia, IUGR, and cesarean section were more significantly associated with the iatrogenic group. Conclusion Our study provides a general overview of the associated etiological factors and perinatal health concerns associated with preterm birth in a rural/semi-urban setting in Eastern India. The findings might provide essential data for taking steps toward the prevention and management of preterm birth from a developing country's perspective.

Family planning practices among women seeking induced abortion: An institution-based cross-sectional study from Eastern India.

Introduction: Unmet need for contraceptive use indicates the gap between women's reproductive intentions and their contraceptive behavior. It is a direct contributor to the increased incidence of unwanted pregnancies leading to abortion. Abortions, particularly septic abortions constitute an important cause of maternal morbidity and mortality. Objective: This study was conducted to determine the pattern of family planning practices among women seeking an induced abortion. The study also aimed to assess the awareness and attitude towards contraceptive methods along with reasons for the nonuse of contraceptives in this study population. Methods: An institution-based cross-sectional study was conducted during October 2020 to October 2021. Data was collected using a preformed validated structured questionnaire. Descriptive statistics was used to describe data. The Chi-square test was used to find the significance of differences between categorical variables. Results: A total of 256 pregnant women seeking induced abortion were recruited. Despite high knowledge (99.2%) and attitude (63.7%), a history of contraceptive use could be elicited in 43.8% of study subjects. The most common contraceptive methods used previously were oral contraceptive pills followed by the barrier method of contraception. A significant association was found between contraceptive use and age of the woman, urban or rural background, and marital status. Unplanned sex or infrequent sex was the most common reason for the nonuse of contraceptives followed by fear of side effects. Conclusion: Enhancement of knowledge of contraceptive users through adequate information by health care providers can be helpful. Consideration of socio-demographic characteristics of women and contraceptive barriers is indispensable in implementing family planning interventions.

Limiting adverse birth outcomes in resource-limited settings (LABOR): protocol of a prospective intrapartum cohort study.

Background: Each year, nearly 300,000 women and 5 million fetuses or neonates die during childbirth or shortly thereafter, a burden concentrated disproportionately in low- and middle-income countries. Identifying women and their fetuses at risk for intrapartum-related morbidity and death could facilitate early intervention. Methods: The Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR) Study is a multi-country, prospective, observational cohort designed to exhaustively document the course and outcomes of labor, delivery, and the immediate postpartum period in settings where adverse outcomes are frequent. The study is conducted at four hospitals across three countries in Ghana, India, and Zambia. We will enroll approximately 12,000 women at presentation to the hospital for delivery and follow them and their fetuses/newborns throughout their labor and delivery course, postpartum hospitalization, and up to 42 days thereafter. The co-primary outcomes are composites of maternal (death, hemorrhage, hypertensive disorders, infection) and fetal/neonatal adverse events (death, encephalopathy, sepsis) that may be attributed to the intrapartum period. The study collects extensive physiologic data through the use of physiologic sensors and employs medical scribes to document examination findings, diagnoses, medications, and other interventions in real time. Discussion: The goal of this research is to produce a large, sharable dataset that can be used to build statistical algorithms to prospectively stratify parturients according to their risk of adverse outcomes. We anticipate this research will inform the development of new tools to reduce peripartum morbidity and mortality in low-resource settings.

Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol.

INTRODUCTION: Ending preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, <2.5 kg) infants. The majority of LBW infants are born in low- and middle-income countries (LMICs) and account for more than 60%-80% of newborn deaths. Feeding promotion tailored to meet the nutritional needs of LBW infants in LMICs may serve a crucial role in curbing newborn mortality rates and promoting growth. The Low Birthweight Infant Feeding Exploration (LIFE) study aims to establish foundational knowledge regarding optimal feeding options for LBW infants in low-resource settings throughout infancy. METHODS AND ANALYSIS: LIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants. ETHICS AND DISSEMINATION: This study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities. TRIAL REGISTRATION NUMBERS: NCT04002908 and CTRI/2019/02/017475.

Comparison of Fetomaternal Outcomes in Patients With Gestational Diabetes Mellitus Treated With Insulin Versus Acarbose: Results of a Prospective, Open Label, Controlled Study.

Objective To evaluate fetomaternal outcomes in patients with gestational diabetes mellitus (GDM) treated with insulin versus acarbose. Material and methods In this prospective, open label, controlled study, GDM patients treated with insulin or acarbose were observed till six weeks after delivery. Maternal outcomes, fetal outcomes and glycemic control were compared between two groups.  Results Fifty patients in each group (insulin group-mean age 28.52 years; acarbose group-mean age 26.26 years; p=0.020) were included. There was no difference in body mass index (p=0.157), family history of diabetes (p=0.648), history of GDM (p=0.50) or mean gestational age at diagnosis (p=0.245) between the two groups. There was no significant difference in the incidence of recurrent infections (p=0.64), pre-eclampsia (p=0.64) or premature rupture of membranes (p=0.40) between the two groups. Mean duration of gestational weeks at the time of delivery in the insulin and acarbose group was 36.93 and 38.36 weeks respectively (p=0.002). There was no difference in the modes of delivery, mean post-operative random blood glucose (p=0.96), fasting blood glucose level at day seven (p=0.15) and after six weeks (p=0.83) between the insulin and acarbose groups. There was no difference in reduction in the postprandial blood glucose level at day seven (p=0.48) and after six weeks (p=0.23). There was no significant difference in the mean birth weight of babies born to mothers treated with the two drugs (p=0.21). There was no difference in the incidence of neonatal complications between the two groups. Conclusion Acarbose can be an effective and well tolerated option for treatment of gestational diabetes mellitus.

Effect of maternal anthropometry and metabolic parameters on fetal growth.

OBJECTIVE: The aim of this study was to determine the effect of maternal anthropometry and metabolic parameters on neonatal anthropometry. MATERIALS AND METHODS: This observational cross-sectional study was conducted from January 2008 to June 2009 at a single tertiary care center. Maternal anthropometry and metabolic parameters like fasting serum insulin, lipid profile, and random blood glucose were estimated in 50 pregnant women at term. Detailed anthropometry of the neonates was performed. RESULTS: Large for gestational age (LGA) babies had higher maternal body mass index (BMI), fasting serum insulin, and cord blood insulin levels, and lower maternal high density lipoprotein (HDL) compared to appropriate for gestational age (AGA) group (P < 0.001). Among the maternal parameters, BMI, gestational age, fasting serum insulin, and random blood sugar (RBS) had significant positive correlation, while HDL had negative correlation with birth weight (P < 0.05). However, only maternal BMI was the significant predictor of neonatal birth weight on multiple regression analysis (ß = 0.340, P = 0.01). CONCLUSION: The BMI of glucose-tolerant mother is more important than metabolic parameters in determining the birth weight of term babies.

Beta-cell function and insulin resistance in pregnancy and their relation to fetal development.

BACKGROUND: Insulin resistance in pregnancy is consequent to the physiological adaptation necessary to provide glucose to the growing fetus. Disturbance in the maternal metabolism can induce structural and functional adaptations during fetal development. METHODS: Pregnant women with duration of conception between 24 and 28 weeks were assessed for insulin resistance (IR) and beta-cell function by using homeostatic model assessment IR (HOMA-IR) and homeostatic model assessment of beta-cell function (HOMA-B) models, respectively. One hundred pregnant women and 42 age-matched controls were taken for the study. Fourteen pregnant women were diagnosed as gestational diabetes mellitus (GDM) as per World Health Organization (WHO) criteria. RESULTS: Pregnant women with normal glucose tolerance (NGT) did not reveal significant IR as compared to controls but the HOMA-B was higher (268.91 +/- 197.16 vs 188.6 +/- 88.83, P < 0.01), suggesting excessive beta-cell function to maintain glucose homeostasis. The subset of pregnant women who presented with GDM had significantly higher HOMA-IR values (6.59 +/- 2.93 vs. 1.77 +/- 1.49, P < 0.001) and similar HOMA-B values as compared to pregnant women with NGT. Pregnant women with severe IR manifested as GDM, even without any previous history of dysglycemia. CONCLUSIONS: With regard to fetal outcome, HOMA-IR is an independent predictor in pregnant women with NGT (biparietal diameter r(2) = 0.204, P < 0.01; weight r(2) = 0.097, P < 0.01), whereas beta-cell function (HOMA-B) is a strong independent predictor of fetal outcome in pregnant GDM (biparietal diameter r(2) = 0.58, P < 0.05; FL r(2) = 0.71, P < 0.01 AC r(2) = 0.79, P < 0.001; weight r(2) = 0.57, P < 0.01).

Effect of metformin in asian Indian women with polycystic ovarian syndrome.

BACKGROUND: This study was conducted to study the therapeutic benefits of metformin and to determine the correction of insulin resistance on 25 patients of polycystic ovarian syndrome (PCOS) attending the Department of Obstetrics and Gynaecology, S.C.B. Medical College and Hospital, Cuttack, India, for varying complaints. METHODS: Twenty-five women diagnosed as having PCOS received metformin in doses of 500 mg every 8 h for 6 months. Periodical evaluation with respect to clinical improvement was done after months 3 and 6, while evaluations of changes in biochemical parameters and hormone levels were done at the end of month 6. RESULTS: Out of 23 cases (92%) women who presented with menstrual disturbances, the cycles were regularized in 21 (91%). Fourteen women complained of infertility, and five (35.7%) of them conceived within the span of treatment. In six (24%) cases with complaints of hirsutism, there was improvement in three cases (50%). Twelve (91.6%) of obese patients with PCOS had weight loss with significant changes in waist-to-hip ratio (WHR) after metformin therapy. Of the three patients with low FSH, the level became normal in two cases. Polycystic changes in ovary regressed in 12 (85.7%) cases. Of the 13 patients with elevated serum testoterone level, normalization of values was seen in 12 cases. Abnormal LH/FSH ratio and impaired glucose tolerance were normalized, and insulin resistance was significantly reduced in all the cases studied, with mean HOMA values decreasing from 3.34 to 1.82. CONCLUSIONS: This study conclusively points out the beneficial effects of metformin in cases of PCOS in Asian women, both in the adolescent and the reproductive age. This mode of treatment is successful and has an etiological rationale behind its use. The additional benefits are a relatively low cost of therapy and diminished hazards associated with surgical intervention.