Late-Preterm Antenatal Steroids for Reduction of Neonatal Respiratory Complications: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of antenatal corticosteroids in reducing neonatal respiratory complications when administered to those at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. METHODS: This was a single-center, triple-blind, randomized, placebo-controlled trial in southern India enrolling pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. Computer-generated block randomization was used with participants randomized to either one course of intramuscular betamethasone or placebo. The primary outcome was a composite of treatment for respiratory distress in the neonate, defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Neonatal secondary outcomes were transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycemia, stillbirth, and early neonatal death; maternal secondary outcomes were chorioamnionitis, postpartum hemorrhage, puerperal fever, and length of hospitalization. All analyses were based on intention to treat. A sample size of 1,200 was planned with 80% power to detect a 30% reduction in rates of respiratory distress. After a planned interim analysis, enrollment was stopped for futility. RESULTS: From March 2020 to August 2022, 847 participants were recruited, with 423 participants randomized to betamethasone and 424 participants randomized to placebo. There were 22 individuals lost to follow-up. There was no statistically significant difference in the primary outcome (betamethasone 4.9% vs placebo 4.8%, relative risk 1.03, 95% CI, 0.57-1.84, number needed to treat 786). There were no statistically significant differences in secondary neonatal or maternal outcomes. CONCLUSION: Betamethasone administered in the late-preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2019/09/021321.

Study protocol: 'a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India'.

INTRODUCTION: In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care. METHODS AND ANALYSIS: A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal care ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published. TRIAL REGISTRATION NUMBER: CTRI/2022/03/041343.

Efficacy of Antenatal Ultrasound Examination in Diagnosis of Congenital Cardiac Anomalies in an Unselected Population: Retrospective Study from a Tertiary Centre.

BACKGROUND: In Low- and Middle-Income Countries like India, where the services and surgical care for Congenital Heart Disease (CHD) are available only in selected centres with geographical variations, it is important to detect Heart defects early and give the parents an opportunity to plan ahead for seeking appropriate care at the earliest. Several developments in recent years such as improvement of quality of ultrasound machines, sonographer's experience, skills and better description of cardiac views have contributed to improve detection rate. METHODS: A retrospective study was done between March 2016 and December 2019, and showed ultrasound evidence of CHD was included. RESULTS: The total number of morphology scans done during study period was 50,435. The number of congenital anomalies detected was 1482, out of which CHD was detected in 334 (22.5%). Outcome of 50 pregnancies were not available while the rest (284) were available for follow up in post-natal period. There were 51 cases of CHD, missed on routine antenatal morphological screening, which were diagnosed in the post-natal period. There were 18 cases of over-diagnosed CHD on antenatal scan, but were found to have normal echo findings after birth. CONCLUSION: A systematic approach is crucial for practitioner to determine the patterns of associated defects. Use of step wise strategy helps in determining the correct diagnosis of isolated cardiac defect, associated with other system or a part of syndrome. Systematic audit of morphological scans could play an important role in improving the diagnostic accuracy, which in turn will lead to early detection.

Digital stretching of cervix in the active phase of labour to shorten its duration: a randomised control trial.

An assessment of the efficacy and satisfaction of women in active labour having digital cervical stretching compared to women who did not have this intervention. Ours was a randomised controlled trial at a tertiary centre in India. Low-risk women at term with vertex presentation in active labour with ruptured membranes and cervical dilation of 4-6 cm were included. Stretching to delivery interval was 247.5 ± 158.2 min in the intervention group and 265.5 ± 158.4 in the control group. The mode of delivery, incidence of cervical tear, and maternal, fetal and neonatal complications were similar in both groups. The Labour and Delivery Satisfaction Index (LADSI) was similar in both groups. While no significant discomfort was perceived with stretching, it does not appear to expedite labour.

Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour.

OBJECTIVE: To compare the efficacy of preinduction outpatient use of a single dose of 25 µg vaginal misoprostol between 381/2 and 40 weeks with that of placebo, to decrease the interval from intervention to delivery after stretch and sweep in low-risk gravid women with Bishop's score <4. METHOD: Sixty three women received 25 µg vaginal misoprostol and 63 women received placebo after stretch and sweep. RESULTS: The duration from intervention to delivery was 3.35 (1.12-9.46) days in the misoprostol group and 5.42 (2.39-10.11) days in the placebo group which was statistically significant (p = 0.029). Spontaneous labor was seen in 39 women (61.9 %) in the misoprostol group and 35 women (55.6 %) in the placebo group (p = 0.531). Eight women in the misoprostol group and 18 in the placebo group had Lower Segment Caesarean Section (LSCS) and this difference was also statistically significant (p = 0.027). There were no major maternal and neonatal complications in both groups. CONCLUSION: Preinduction use of 25 µg vaginal misoprostol after stretch and sweep in the outpatient setting decreased the intervention to delivery interval when compared to placebo.

Umbilical Cord Haematoma Causing Still Birth- A Case Report.

Still birth continues to be one of the many challenges that an obstetrician has to face. Still births that occur in the antenatal period are more difficult to explain than that which occurs intrapartum. The latter is most often due to intrapartum asphyxia, medical complications or infections; however a cause for antenatal still birth is difficult to ascertain. A thorough examination of the case along with necessary investigations might not necessarily reveal any cause and this leads to considerable anxiety for both the mother and the treating obstetrician. In the investigation of a case of still birth a detailed examination of the placenta and cord has to be emphasised as a considerable number of still births that are thought to be unexplained may be attributable to placental or cord pathologies. Here we present one such case where an umbilical cord haematoma resulted in intrauterine foetal death.

Pregnancy outcome in relation to treatment of murine typhus and scrub typhus infection: a fever cohort and a case series analysis.

BACKGROUND: There is a paucity of published reports on pregnancy outcome following scrub and murine typhus despite these infections being leading causes of undifferentiated fever in Asia. This study aimed to relate pregnancy outcome with treatment of typhus. METHODOLOGY/PRINCIPAL FINDINGS: Data were analyzed from: i) pregnant women with a diagnosis of scrub and/or murine typhus from a fever cohort studies; ii) case series of published studies in PubMed using the search terms "scrub typhus" (ST), "murine typhus" (MT), "Orientia tsutsugamushi", "Rickettsia tsutsugamushi", "Rickettsia typhi", "rickettsiae", "typhus", or "rickettsiosis"; and "pregnancy", until February 2014 and iii) an unpublished case series. Fever clearance time (FCT) and pregnancy outcome (miscarriage and delivery) were compared to treatment. Poor neonatal outcome was a composite measure for pregnancies sustained to 28 weeks or more of gestation ending in stillbirth, preterm birth, or delivery of a growth restricted or low birth weight newborn. RESULTS: There were 26 women in the fever cohort. MT and ST were clinically indistinguishable apart from two ST patients with eschars. FCTs (median [range] hours) were 25 [16-42] for azithromycin (n=5), 34 [20-53] for antimalarials (n=5) and 92 [6-260] for other antibiotics/supportive therapy (n=16). There were 36.4% (8/22) with a poor neonatal outcome. In 18 years, 97 pregnancies were collated, 82 with known outcomes, including two maternal deaths. Proportions of miscarriage 17.3% (14/81) and poor neonatal outcomes 41.8% (28/67) were high, increasing with longer FCTs (p=0.050, linear trend). Use of azithromycin was not significantly associated with improved neonatal outcomes (p=0.610). CONCLUSION: The published ST and MT world literature amounts to less than 100 pregnancies due to under recognition and under diagnosis. Evidence supporting the most commonly used treatment, azithromycin, is weak. Collaborative, prospective clinical trials in pregnant women are urgently required to reduce the burden of adverse maternal and newborn outcomes and to determine the safety and efficacy of antimicrobial treatment.

Early diagnosis of a large vesical calculus complicating pregnancy.

Vesical calculus-complicating pregnancy is rare. This is a case report of a large vesical calculus-complicating pregnancy. The early diagnosis and appropriate surgical management of the large vesical calculus prevented complications like recurrent urinary tract infections and obstructed labor. It enabled the mother to have an uneventful vaginal delivery.