Impact of early versus delayed umbilical cord clamping on term neonates' haemoglobin levels: a randomized controlled trial.

OBJECTIVE: To compare the effects of early and delayed cord clamping on the haemoglobin levels of neonates delivered at term. METHODS: This randomized controlled trial enrolled pregnant women during the second stage of labour. They were randomized into either the early cord clamping (ECC) group or the delayed cord clamping (DCC) group in the ratio of 1:1. Following delivery of the baby, the umbilical cords of participants in the ECC group were clamped within 30 s of delivery of the neonate while those of participants in the DCC group were clamped after 2 min from the delivery of the neonate. The primary outcome measure was the effect of ECC and DCC on the haemoglobin levels of neonates delivered at term. RESULTS: A total of 270 pregnant women were enrolled in the study. Their baseline sociodemographic and clinical characteristics were similar in both groups. There was no significant difference in the mean haemoglobin level between ECC and DCC groups at birth. The mean haemoglobin level of the neonates at 48 h postpartum was significantly higher in the DCC group than the ECC group. CONCLUSION: DCC at birth was associated with a significant increase in neonatal haemoglobin levels at 48 h postpartum when compared with ECC.Trial Registration: The trial was registered at Pan African Clinical Trial Registry with approval number PACTR202206735622089.

Efficacy of zinc supplementation for the treatment of dysmenorrhoea: a double-blind randomised controlled trial.

OBJECTIVES: To determine the efficacy of zinc sulfate supplementation in managing dysmenorrhoea. METHODS: In total, 103 high school students were randomised into an experimental arm (52 students) and a control arm (51 students) and received 40-mg zinc sulfate or placebo, respectively, over three cycles. Primary outcome measures were the mean Visual Analogue Scale score, which measured pain over three cycles, and the frequency of nausea and vomiting. Secondary outcomes were the use of additional analgesics and the frequency of allergic reactions. RESULTS: Fifty participants were analysed in each group. Mean pain scores were not significantly different between the groups before administering zinc sulfate therapy. Following the intervention, the mean pain scores for the treatment (2.80 ± 2.28) and placebo (3.48 ± 2.85) groups were not significantly different in the first cycle; however, scores in the treatment group were significantly better in the second (2.56 ± 1.97 vs 3.80 ± 2.77) and third (1.95 ± 1.72 vs 3.95 ± 2.82) cycles. No significant differences were observed between the groups in the nausea and vomiting incidence and the requirement for additional analgesics. CONCLUSIONS: Zinc sulfate reduces dysmenorrhoea severity with minimal or no adverse effects, especially with more than one cycle of usage.Trial Registration Number: PACTR202105843292338. The trial is publicly available and was registered at www.pactr.org on 25 May 2021.

A randomized clinical trial of Premaquick biomarkers versus transvaginal cervical length for pre-induction cervical assessment at term among pregnant women.

Objectives: To compare Premaquick biomarkers (combined insulin-like growth-factor binding protein 1 and interleukin-6) and cervical length measurement via transvaginal ultrasound for pre-induction cervical evaluation at term among pregnant women. Methods: A randomized clinical trial of consenting pregnant women at the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. The women were randomized equally into Premaquick group (n = 36) and transvaginal ultrasound group (n = 36). The cervix was adjudged 'ripe' if the Premaquick test was positive or if the trans-vaginal measured cervical length was less than 28 mm. The primary outcome measures were the proportions of women who needed prostaglandin analogue for cervical ripening and the proportion that achieved vaginal delivery after induction of labour. The trial was registered in Pan African clinical trial registry (PACTR) registry with approval number PACTR202001579275333. Results: The baseline characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups in terms of proportion of women that required prostaglandins for pre-induction cervical ripening (41.7 versus 47.2%, p = 0.427), vaginal delivery (77.8 versus 80.6%, p = 0.783), mean induction to delivery interval (22.9 ± 2.81 h versus 24.04 ± 3.20 h, p = 0.211), caesarean delivery (22.2 versus 19.4%, p = 0.783), proportion of neonate with birth asphyxia (8.30 versus 8.30%, p = 1.00) and proportion of neonate admitted into special care baby unit (16.7 versus 13.9%, p = 0.872). Subgroup analysis of participants with 'ripe' cervix at initial pre-induction assessment showed that the mean induction to active phase of labour interval and mean induction to delivery interval were significantly shorter in Premaquick than transvaginal ultrasound group. Conclusion: Pre-induction cervical assessment at term with either Premaquick biomarkers or transvaginal ultrasound for cervical length is effective, objective and safe with similar and comparable outcome. However, when compared with women with positive transvaginal ultrasound at initial assessment, women with positive Premaquick test at initial assessment showed a significantly shorter duration of onset of active phase of labour and delivery of baby following induction of labour.

Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy.

PURPOSE: To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures. METHODS: Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (n = 68) or Veress needle access (n = 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO2 required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis. RESULTS: Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min; p < 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO2 used, number of attempts for successful entry, and major/minor complications (p > 0.05). CONCLUSIONS: Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation. CLINICAL TRIAL REGISTRATION: PACTR201510000999192.

Call for proper documentation of COVID-19 deaths in poor resource setting: a necessity for management of future occurrences.

INTRODUCTION: A Pandemic is an epidemic at a global scale. The word 'epidemic' has the potential to lead to chaotic, unreasoned responses to health problems, especially when used by journalists. Nigeria like other poor resource countries is equally affected by the current coronavirus disease 2019 (COVID-19) pandemic. Standardization and proper documentation of the mortality of the COVID-19 in the poor-resource countries will help in managing other disease outbreaks in future. This paper calls for improvement in capturing of these data for better planning in the future. AREAS COVERED: Quality data is very essential for policy makers to appreciate any disease condition. In order to present a comprehensive picture of COVID-19 mortality, the deaths were broadly grouped into two as follows: direct and indirect COVID-19 deaths. Most of the current reported deaths seem to be direct deaths. EXPERT OPINION: We propose that for better estimation and standardization, verbal autopsy could be used to differentiate direct/indirect COVID deaths. At full development, this model could be applied to other diseases, outbreaks, or pandemics. The disease surveillance officers, and other health workers can be trained in this regard as well as scaling up the e-surveillance of the DSNOs.

Diagnostic value of Chorioquick for detecting chorioamnionitis in women with premature rupture of membranes.

OBJECTIVE: To determine the accuracy of a semi-quantitative interleukin-6 (IL-6) vaginal secretion rapid test (Chorioquick) for detecting chorioamnionitis in women with premature rupture of membranes (PROM). METHODS: A prospective cohort study in five tertiary hospitals in Nigeria involved women with confirmed PROM at term and preterm PROM with or without suspected chorioamnionitis from August 1, 2017, to October 31, 2018. Cervicovaginal fluid samples were tested for chorioamnionitis using the Chorioquick test. Samples were repeated at decision to deliver. The test was considered positive if at least the indicator 'IL-6 low' of the three Chorioquick biomarkers (low, medium, high) was positive, or negative if none of the biomarkers were positive. Chorioamnionitis was histologically confirmed post-delivery using three tissue samples. Primary outcome measures were sensitivity, specificity, and accuracy. RESULTS: Of 73 women, on histological confirmation, 39 were true positive and 29 were true negative (for chorioamnionitis) to the Chorioquick test at repeat assessment. Overall, the Chorioquick test had a sensitivity of 97.5% (95% confidence interval [CI] 85.3-99.9), specificity 87.9% (70.9-96.0), and accuracy 93.2% (79.5-99.1). Sub-group analysis of women <37 weeks of pregnancy showed a sensitivity of 100.0% (95% CI 83.4-100.0), specificity of 91.3% (70.5-98.5), and accuracy of 95.8% (82.5-99.5). Triple positive samples were 100.0% specific in all gestations. CONCLUSION: Chorioquick showed favorable utility for detecting chorioamnionitis in PROM and could be a reliable, non-invasive rapid tool in a real-world clinical setting.