Justification: During the current rapidly evolving pandemic of COVID-19 infection, pregnant women with suspected or confirmed COVID-19 and their newborn infants form a special vulnerable group that needs immediate attention. Unlike other elective medical and surgical problems for which care can be deferred during the pandemic, pregnancies and childbirths continue. Perinatal period poses unique challenges and care of the mother-baby dyads requires special resources for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period. Process: The GRADE approach recommended by the World Health Organization was used to develop the guideline. A Guideline Development Group (GDG) comprising of obstetricians, neonatologists and pediatricians was constituted. The GDG drafted a list of questions which are likely to be faced by clinicians involved in obstetric and neonatal care. An e-survey was carried out amongst a wider group of clinicians to invite more questions and prioritize. Literature search was carried out in PubMed and websites of relevant international and national professional organizations. Existing guidelines, systematic reviews, clinical trials, narrative reviews and other descriptive reports were reviewed. For the practice questions, the evidence was extracted into evidence profiles. The context, resources required, values and preferences were considered for developing the recommendations. Objectives: To provide recommendations for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period. Recommendations: A set of twenty recommendations are provided under the following broad headings: 1) pregnant women with travel history, clinical suspicion or confirmed COVID-19 infection; 2) neonatal care; 3) prevention and infection control; 4) diagnosis; 5) general questions.
IntroductionThe pro‐ and anti‐inflammatory cytokines play crucial role in the development and functions of placenta. Any changes in these cytokines may be associated with many pregnancy‐related disorders like preeclampsia. Therefore, the present study is aimed to study the expression of pro‐inflammatory (TNF‐α, IL‐6) and anti‐inflammatory (IL‐4, IL‐10) cytokines in placenta and serum of preeclamptic pregnant women.Material and MethodsFor this study, a total of 194 cases of preeclamptic and control cases were enrolled in two Groups as per the gestational age that is, Group I (28‐36 weeks) and II (37 weeks onwards). The number of samples was 55 in Group I and 139 in Group II. The immunohistochemistry (IHC) and enzyme‐linked immunosorbent assay (ELISA) were conducted on placenta and serum of both preeclamptic and normal samples, respectively. IHC results were revalidated by reverse transcriptase PCR (RT‐PCR).ResultsBoth Groups (I, II) of preeclampsia showed amended levels of pro‐ and anti‐inflammatory cytokines in placental tissues and serum samples. The levels of TNF‐α and IL‐6 were significantly increased in preeclamptic cases (P = 0.0001, P = 0.0001) while the IL‐4 and IL‐10 were downregulated (P = 0.0001, P = 0.0001) in comparison to control. In addition, a negative correlation was also observed between the two in preeclampsia (P = 0.0001).ConclusionThe balanced ratio of pro‐ and anti‐inflammatory cytokines is essential to regulate the maternal inflammation system throughout pregnancy. Therefore, the gradual cytokine profiling of the pregnant women may be useful for the management of preeclampsia.
IntroductionFor every woman who dies during pregnancy and childbirth, many more suffer ill-health, the burden of which is highest in low-resource settings. We sought to assess the extent and types of maternal morbidity.MethodsDescriptive observational cross-sectional study at primary-level and secondary-level healthcare facilities in India, Pakistan, Kenya and Malawi to assess physical, psychological and social morbidity during and after pregnancy. Sociodemographic factors, education, socioeconomic status (SES), quality of life, satisfaction with health, reported symptoms, clinical examination and laboratory investigations were assessed. Relationships between morbidity and maternal characteristics were investigated using multivariable logistic regression analysis.Results11 454 women were assessed in India (2099), Malawi (2923), Kenya (3145), and Pakistan (3287). Almost 3 out of 4 women had ≥1 symptoms (73.5%), abnormalities on clinical examination (71.3%) or laboratory investigation (73.5%). In total, 36% of women had infectious morbidity of which 9.0% had an identified infectious disease (HIV, malaria, syphilis, chest infection or tuberculosis) and an additional 32.5% had signs of early infection. HIV-positive status was highest in Malawi (14.5%) as was malaria (10.4%). Overall, 47.9% of women were anaemic, 11.5% had other medical or obstetric conditions, 25.1% reported psychological morbidity and 36.6% reported social morbidity (domestic violence and/or substance misuse). Infectious morbidity was highest in Malawi (56.5%) and Kenya (40.4%), psychological and social morbidity was highest in Pakistan (47.3%, 60.2%). Maternal morbidity was not limited to a core at-risk group; only 1.2% had all four morbidities. The likelihood of medical or obstetric, psychological or social morbidity decreased with increased education; adjusted OR (95% CI) for each additional level of education ranged from 0.79 (0.75 to 0.83) for psychological morbidity to 0.91 (0.87 to 0.95) for infectious morbidity. Each additional level of SES was associated with increased psychological morbidity (OR 1.15 (95% CI 1.10 to 1.21)) and social morbidity (OR 1.05 (95% CI 1.01 to 1.10)), but there was no difference regarding medical or obstetric morbidity. However, for each morbidity association was heterogeneous between countries.ConclusionWomen suffer significant ill-health which is still largely unrecognised. Current antenatal and postnatal care packages require adaptation if they are to meet the identified health needs of women.
Background Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.Methods We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1•14% under the null effects, 3•0% under the continued effects, and 44•83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626.
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