Weldegebreal Fitsum, Ayana Desalegn Admassu, Wilfong Tara, Dheresa Merga, Yadeta Tesfaye Assebe, Negesa Akewok Sime, Demmu Yohannes Mulugeta, Tesfa Tewodros, Alemu Tegbaru Nibrat, Eticha Tadesse Gure, Geremew Abraham, Roba Kedir Teji, Abdissa Alemseged, Assefa Nega, Negash Abel Abera, Cools Piet, Tura Abera Kenay
School of Medical Laboratory Sciences, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia
Laboratory Bacteriology Research, Department of Diagnostic Sciences, Ghent University Faculty of Medicine and Health Sciences, Gent, Belgium.
BMJ Open. 2025 Jan 6;15(1):e092461. doi: 10.1136/bmjopen-2024-092461.
Although evidence exists on the impact of microbiota on pregnancy outcomes in many high-resource settings, there is a lack of research in many low-resource settings like Ethiopia. This study aims to fill this gap by studying the gut and vaginal microbiota changes throughout pregnancy and assess how these changes relate to pregnancy outcomes among a cohort of pregnant women in eastern Ethiopia.
Vaginal and stool samples will be collected using DNA/RNA Shield Collection kits three times starting at 12-22 weeks, 28-36 weeks and at birth (within 7 days). Postnatally, newborns' skin swabs (at birth) and rectal swabs will be obtained until 2 years of age. Moreover, breast milk samples at birth and 6 months and environmental samples (water, indoor air and soil) will be collected at enrolment, birth, 6, 12 and 24 months post partum. DNA will be extracted using Roche kits. Metagenomic sequencing will be performed to identify metataxonomic profiling and assess variations in microbial profiles, and α and β diversity of the microbiota. Information on socioeconomic, behavioural, household and biological factors will be collected at enrolment. The collected data will be coded, entered into EpiData 3.1 and analysed using Stata 17.
The Institutional Health Research Ethics Review Committee (Ref No. IHRERC/033/2022) of Haramaya University, Ethiopia has approved this study ethically. Written informed consent regarding the study and sample storage for biobanking will be obtained from all participants. Results will be published in international peer-reviewed journals, and summaries will be provided to the study funders. Clinical study data will be submitted to Data Compass (https://datacompass.lshtm.ac.uk/), and molecular profiles of the microbiome and whole-genome sequences will be submitted to the European Nucleotide Archive (https://www. ebi.ac.uk/ena). Requests for data should be directed to daberaf@gmail.com. The decision to share data will be made by the study steering committee under the College of Health and Medical Sciences, Haramaya University, Ethiopia.
尽管在许多资源丰富的地区已有关于微生物群对妊娠结局影响的证据，但在埃塞俄比亚等许多资源匮乏的地区仍缺乏相关研究。本研究旨在通过研究埃塞俄比亚东部一组孕妇整个孕期肠道和阴道微生物群的变化，并评估这些变化与妊娠结局的关系来填补这一空白。
使用DNA/RNA Shield采集试剂盒在孕12 - 22周、28 - 36周和出生时（7天内）三次采集阴道和粪便样本。产后，采集新生儿出生时的皮肤拭子和直肠拭子，直至2岁。此外，在出生时、6个月时采集母乳样本，并在入组时、出生时、产后6、12和24个月采集环境样本（水、室内空气和土壤）。使用罗氏试剂盒提取DNA。进行宏基因组测序以鉴定元分类学特征，并评估微生物特征的变化以及微生物群的α和β多样性。在入组时收集社会经济、行为、家庭和生物学因素的信息。收集到的数据将进行编码，录入EpiData 3.1并使用Stata 17进行分析。
埃塞俄比亚哈拉马亚大学的机构健康研究伦理审查委员会（参考编号：IHRERC/033/2022）已在伦理上批准了本研究。将从所有参与者处获得关于本研究及生物样本库样本存储的书面知情同意书。研究结果将发表在国际同行评审期刊上，并向研究资助者提供总结。临床研究数据将提交至数据指南针（https://datacompass.lshtm.ac.uk/），微生物组的分子特征和全基因组序列将提交至欧洲核苷酸档案库（https://www.ebi.ac.uk/ena）。数据请求应发送至daberaf@gmail.com。数据共享的决定将由埃塞俄比亚哈拉马亚大学健康与医学科学学院的研究指导委员会做出。
