背景:单绒毛膜双胎妊娠的选择性胎儿生长受限(sFGR),定义为一对双胞胎的估计胎儿体重(EFW)<10百分位,EFW不一致≥25%,这对双胞胎来说都与死产和神经残疾有关.这种情况带来了独特的管理困难:一方面,继续怀孕会有较小的双胞胎死亡的风险,同胎死亡的风险很高(40%)或同胎神经系统后遗症(30%)。另一方面,早期分娩以防止较小的双胞胎死亡可能会使较大的双胞胎早产,与长期身体的相关风险,神经残疾的情感和财务成本,比如脑瘫。当有严重和早期sFGR时,在生存能力之前,交付不是一种选择。在这种情况下,目前主要有三种管理选择:(1)预期管理,(2)选择性终止较小的孪生和(3)胎盘激光光凝术的互连血管。这些管理选项从未在随机对照试验(RCT)中进行过研究。最好的管理选择是未知的,潜在的RCT面临许多挑战。其中包括罕见的情况,导致少数合格的怀孕,不确定孕妇是否同意参加此类试验,以及她们是否同意随机接受期待管理或积极的胎儿干预,以及稳健和长期成果措施的挑战。因此,FERN研究的主要目的是评估在早发(24周前)sFGR的单绒毛膜双胎妊娠中进行积极干预和期待治疗的RCT的可行性.
方法:FERN研究是一项前瞻性混合方法可行性研究。主要目的是通过探索女性的偏好来推荐单绒毛膜双胎妊娠sFGR干预与期待管理的RCT是否可行,临床医生的偏好,当前的做法、均衡和案件数量。为了实现这一点,我们提出了三个不同的工作包(WP)。WP1:一项前瞻性英国多中心研究,WP2A:一项定性研究,探索父母和临床医生的观点和WP3:确定试验可行性的共识发展。符合条件的怀孕将被招募到WP1和WP2,这将同时运行。这两个WP的结果将用于WP3,以就未来的确定性研究达成共识。研究的持续时间将是53个月,由10个月的设置组成,39个月的招聘,42个月的数据收集,5个月的数据分析,报告撰写和建议。WP1的实用样本量为100个具有sFGR的单绒毛膜双胎妊娠。对于WP2,将进行访谈,直到数据饱和和样本方差达到,也就是说,当没有新的重大主题被发现时。根据以前的类似试点研究,在家长组和临床医生组,预计约为15-25次访谈.WP3计划邀请至少50名英国临床医生参与。
背景:本研究已获得健康研究管理局(HRA)西南康沃尔和普利茅斯伦理委员会的伦理批准(REC参考文献20/SW/0156,IRASID286337)。所有参与的站点都将接受特定站点的批准,以便HRA评估能力和能力。这项研究的结果将发表在同行评审的期刊上,并在国家和国际会议上发表。FERN项目的结果将用于指导未来的研究。
背景:本研究包含在ISRCTN注册中心(ISRCTN16879394)和NIHR中央投资组合管理系统(CPMS)中,CRN:生殖健康和分娩专业(UKCRN参考47201)。
BACKGROUND: Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management difficulties: on the one hand, continuation of the pregnancy carries a risk of death of the smaller twin, with a high risk of co-twin demise (40%) or co-twin neurological sequelae (30%). On the other, early delivery to prevent the death of the smaller twin may expose the larger twin to prematurity, with the associated risks of long-term physical, emotional and financial costs from neurodisability, such as cerebral palsy.When there is severe and early sFGR, before viability, delivery is not an option. In this scenario, there are currently three main management options: (1) expectant management, (2) selective termination of the smaller twin and (3) placental laser photocoagulation of interconnecting vessels. These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. These include the rarity of the condition resulting in a small number of eligible pregnancies, uncertainty about whether pregnant women will agree to participate in such a trial and whether they will agree to be randomised to expectant management or active fetal intervention, and the challenges of robust and long-term outcome measures. Therefore, the main objective of the FERN study is to assess the feasibility of conducting an RCT of active intervention vs expectant management in monochorionic twin pregnancies with early-onset (prior to 24 weeks) sFGR.
METHODS: The FERN study is a prospective mixed-methods feasibility study. The primary objective is to recommend whether an RCT of intervention vs expectant management of sFGR in monochorionic twin pregnancy is feasible by exploring women\'s preference, clinician\'s preference, current practice and equipoise and numbers of cases. To achieve this, we propose three distinct work packages (WPs). WP1: A Prospective UK Multicentre Study, WP2A: a Qualitative Study Exploring Parents\' and Clinicians\' Views and WP3: a Consensus Development to Determine Feasibility of a Trial. Eligible pregnancies will be recruited to WP1 and WP2, which will run concurrently. The results of these two WPs will be used in WP3 to develop consensus on a future definitive study. The duration of the study will be 53 months, composed of 10 months of setup, 39 months of recruitment, 42 months of data collection, and 5 months of data analysis, report writing and recommendations. The pragmatic sample size for WP1 is 100 monochorionic twin pregnancies with sFGR. For WP2, interviews will be conducted until data saturation and sample variance are achieved, that is, when no new major themes are being discovered. Based on previous similar pilot studies, this is anticipated to be approximately 15-25 interviews in both the parent and clinician groups. Engagement of at least 50 UK clinicians is planned for WP3.
BACKGROUND: This study has received ethical approval from the Health Research Authority (HRA) South West-Cornwall and Plymouth Ethics Committee (REC reference 20/SW/0156, IRAS ID 286337). All participating sites will undergo site-specific approvals for assessment of capacity and capability by the HRA. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. The results from the FERN project will be used to inform future studies.
BACKGROUND: This study is included in the ISRCTN Registry (ISRCTN16879394) and the NIHR Central Portfolio Management System (CPMS), CRN: Reproductive Health and Childbirth Specialty (UKCRN reference 47201).