Safety of herbal medicine in the postpartum period of a Korean Medicine hospital and postpartum care centre: protocol of a registry study (SAFEHERE-PC)

Introduction
Herbal medicines (HMs) are commonly used during the postpartum period in South Korea. However, the safety concerns associated with these medicines remain unresolved. This study aims to establish a registry of patients receiving HM treatment during the postpartum period and collect clinical data on treatments and adverse reactions to build evidence evaluating the safety of HM use.

Methods and analysis
This study will use a prospective observational registry, including patients admitted to the obstetrics and gynaecology department of the Woosuk University Korean Medicine Hospital’s postpartum care centre. A total of 1000 eligible patients visiting the Korean medicine hospital to recover from various postchildbirth symptoms and opting for HM treatment will be enrolled in the registry. For safety assessment, demographic information, medical history, adverse events (AEs) and treatment details, including HM prescription and concomitant medication usage, will be collected throughout the patient’s hospitalisation period at the postpartum care centre for analysis. Adverse reactions will be monitored daily during hospitalisation, and collected AEs will be analysed for causality using the WHO Uppsala Monitoring Centre causality assessment and the Naranjo Algorithm Score.

Ethics and dissemination
This study was approved by the Institutional Review Board of Woosuk University Korean Medicine Medical Center (WSOH IRB H2311-03-01). The results will be published in peer-reviewed journals or disseminated through conference presentations.

Trial registration number
KCT0009060.

Leggi
Agosto 2024

Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial

Introduction
Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted.

Objective
To determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria.

Methods and analysis
This study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration

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Agosto 2024

Systematic review and meta-analysis of postpartum depression and its associated factors among women before and after the COVID-19 pandemic in Uganda

Objective
This meta-analysis aimed to estimate the national prevalence of postpartum depression (PPD) in Uganda and identify predictors in both pre-COVID-19 and post-COVID-19 eras.

Design
Used a systematic review and meta-analysis methodology.

Data sources
Reviewed papers were sourced from Medline/PubMed, PsycINFO, CINAHL/EBSCOhost, Google Scholar, ScienceDirect and African Journals Online.

Eligibility criteria for selected studies
The review encompassed observational studies published on PPD in Uganda from 1 January 2000 to 30 November 2023.

Results
11 studies (involving 7564 participants) published from 1 January 2000 to 30 November 2023 were reviewed. The pooled prevalence of PPD in Uganda was 29% (95% CI 21% to 37%, I2=98.32%). Subgroup analysis indicated a similar prevalence before (29%, 95% CI 20% to 39%) and during (28%, 95% CI 22% to 32%) the COVID-19 period. Special groups exhibited a higher prevalence (32%, 95% CI 16% to 47%) than general postpartum women (28%, 95% CI 19% to 37%). Factors associated with PPD included poor social support (OR 1.19, 95% CI 1.17 to 1.22, I2=96.8%), maternal illness (OR 1.22, 95% CI 1.19 to 1.26, I2=96.9%), poor socioeconomic status (OR 1.43, 95% CI 1.40 to 1.46, I2=99.5%) and undergoing caesarean section (OR 1.15, 95% CI 1.12 to 1.17, I2=80.6%). Surprisingly, there was a marginal decrease in PPD during the COVID-19 period. Subgroup analysis highlighted a higher prevalence among mothers with HIV.

Conclusion
This study underscores the significant prevalence of PPD in Uganda, with sociodemographic factors increasing risk. Despite a slight decrease during the COVID-19 period, the importance of prioritising maternal mental health is emphasised, considering sociodemographic factors and pandemic challenges, to improve maternal and child health outcomes and overall well-being.

Leggi
Agosto 2024