Investigating biological mechanisms of adverse birth outcomes and early child development in Amhara, Ethiopia: protocol of biospecimen collection and analysis of the Enhancing Nutrition and Antenatal Infection Treatment (ENAT) randomised effectiveness study

Introduction
Maternal undernutrition and infections during pregnancy may influence birth and long-term child development outcomes. Characterising the micronutrient, metabolomic and microbiome profiles of pregnant women and infants may elucidate the underlying biology of adverse birth outcomes and early child development in the first 1000 days.

Methods and analysis
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study was a 2×2 factorial, randomised clinical effectiveness study conducted in Amhara, Ethiopia from August 2020 to June 2022. We cluster-randomised pregnant women (n=2399) to receive either a nutrition intervention (iron-folic acid (IFA), iodised salt and balanced energy-protein supplementation for women with mid-upper arm circumference

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Prospective study on breastfeeding, lipid profile and cardiovascular risk markers in women with familial hypercholesterolaemia: study protocol for the FH-FEMINA study

Introduction
Early and lifelong treatment is essential in patients with familial hypercholesterolaemia (FH) due to genetically elevated low-density lipoprotein cholesterol (LDL-C) from the first years of life. In women with FH, lipid-lowering treatment is interrupted during childbearing years due to contraindication of the medication during conception, pregnancy and breastfeeding. However, little is known about the impact of breastfeeding on lipid profile and other risk markers for atherosclerotic cardiovascular disease (ASCVD) in women with FH compared with women without hypercholesterolaemia, and to what extent statins transfer into breast milk.
We aim to investigate (1) the association between breastfeeding and serum lipid profile in women with and without FH; (2) the association between breastfeeding and other ASCVD risk markers in women with and without FH and (3) the concentration of statins in breast milk of women with FH.

Methods and analysis
FH-FEMINA is a prospective study aiming to include 50 women with FH in Norway, the Netherlands and the Czech Republic. Additionally, 20 women without hypercholesterolaemia will be enrolled as a control group in Norway. Women will be included at the first study visit in gestational week 36, and follow-up visits will be scheduled at 2–4 weeks, and at 3, 6, 9 and 12 months postpartum. Information on lifestyle factors, treatment history and current and previous pregnancies will be collected. At each visit, a non-fasting blood sample, breast milk sample and information on diet, body mass index and blood pressure will be collected. Additional blood samples will be collected from the women with FH at 2, 4, 5, 7, 8, 10 and 11 months postpartum for as long as they are breastfeeding. At (re-)initiation of statin treatment, breast milk samples from women with FH will be collected for drug concentration measurements.

Ethics and dissemination
Ethical approval will be obtained prior to study start in all three countries. Participants will be informed about the study and receive ample time to ask questions before the informed consent form is signed. The findings from this study will be disseminated to healthcare professionals, researchers and patients via peer-reviewed scientific article(s), conferences, patient organisations and social media.

Trial registration number
NCT05367310.

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IFA compliance and associated factors among postpartum mothers: a cross-sectional analytical study at public health facilities in Bharatpur metropolitan city, Chitwan Nepal

Objectives
Iron deficiency anaemia and inadequate compliance with iron–folic acid (IFA) supplementation among pregnant and postpartum women pose substantial public health challenges in Nepal. Hence, this study aimed to determine IFA compliance and identify associated factors among postpartum mothers in Bharatpur Metropolitan City, Chitwan, Nepal.

Design
An analytical cross-sectional design was employed.

Setting
This study was conducted in Bharatpur Metropolitan City, Chitwan, Nepal.

Participants
A total of 286 postpartum mothers were selected using non-probability purposive sampling. Ethical approval was obtained from the Institutional Review Committee of Shree Medical and Technical College, and informed consent was obtained from all participants before data collection. Semi-structured questionnaires were administered through face-to-face interviews to collect data and ensure an in-depth understanding of the participants’ responses.

Results
Among the 286 participants, 53.5% demonstrated compliance with the IFAs. Multivariable logistic regression showed that compliance was significantly and positively linked to the level of education ((AOR)=3.629; 95% CI: (1.438 to 9.153)) and knowledge regarding IFAs (AOR=3.751; 95% CI: (2.145 to 6.562)). The reasons for non-compliance included the consumption of too many tablets, lack of information provided by healthcare workers, experiencing side effects and forgetting to take the tablets.

Conclusions
IFA compliance was observed in more than half of the participants. Compliance was influenced by participants’ education and knowledge. The authors hold a strong conviction that relevant authorities can provide the necessary education in specific areas of concern to enhance the design and improvement of IFA programme strategies.

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