Department of Obstetrics and Gynecology, College of Medicine, University of the Philippines Manila, City of Manila, Philippines
Institute of Child Health and Human Development, National Institutes of Health, University of the Philippines Manila, City of Manila, Metro Manila, Philippines.
BMJ Open. 2022 Apr 25;12(4):e053389. doi: 10.1136/bmjopen-2021-053389.
The novel (COVID-19 was first reported to have originated in Wuhan, China, in December 2019. This new strain, SARS-CoV-2, has spread rapidly worldwide, prompting the WHO to declare the COVID-19 outbreak a global pandemic. The main objective of this cohort study is to determine the risk factors of COVID-19, the modes of COVID-19 vertical transmission, and the maternal and fetal outcomes among non-pregnant and pregnant women and their fetuses.
This is a multicentre epidemiological study that will involve a prospective cohort. COVID-19 status among consulting non-pregnant and pregnant women in public hospitals in Manila, Philippines, will be determined and monitored for 6-12 months. Swab specimens from the nasopharynx, cervix, rectum, amniotic fluid, placenta, cord blood and breastmilk will be collected during consult and admission for reverse transcription-PCR (RT-PCR) testing. Blood will be collected during the postdelivery period to monitor the women and their neonates for any undue development and determine the antibody development to indicate an infective or non-infective state. Evidence of vertical transmission will be explored with the presence or absence of the virus using the maternal and fetal neonatal RT-PCR and lateral flow antibody status. Descriptive and inferential statistics will be done, including the associations between exposures and risk factors, description of clinical characteristics, and the COVID-19 status of the participants.
The Single Joint Research Ethics Board of the Department of Health has approved this protocol (SJREB 2020-30). The study results will be disseminated through conference presentations, peer-reviewed articles, and various stakeholder public forums and activities.
新型冠状病毒肺炎(COVID-19)最初于 2019 年 12 月在中国武汉被报道。这种新型冠状病毒(SARS-CoV-2)已在全球迅速传播,世界卫生组织(WHO)宣布 COVID-19 疫情为全球大流行。本队列研究的主要目的是确定 COVID-19 的危险因素、COVID-19 垂直传播的方式以及非孕妇和孕妇及其胎儿的母婴结局。
这是一项多中心的流行病学研究,将涉及前瞻性队列。将在菲律宾马尼拉的公立医院对咨询的非孕妇和孕妇进行 COVID-19 检测,并对其进行 6-12 个月的监测。在咨询和入院期间,将采集鼻咽、宫颈、直肠、羊水、胎盘、脐血和母乳的拭子标本,用于逆转录聚合酶链反应(RT-PCR)检测。在产后期间采集血液,以监测妇女及其新生儿是否有任何发育异常,并确定抗体的产生情况,以表明感染或非感染状态。将通过使用母体和胎儿新生儿 RT-PCR 和侧向流动抗体状态检测病毒的存在与否来探索垂直传播的证据。将进行描述性和推断性统计,包括暴露和危险因素之间的关联、临床特征描述以及参与者的 COVID-19 状态。
卫生部单一联合研究伦理委员会已批准本方案(SJREB 2020-30)。研究结果将通过会议演讲、同行评议文章以及各种利益相关者公共论坛和活动进行传播。