Yambasu Sahr, Boland Fiona, O'Donoghue Keelin, Curran Colleen, Shahabuddin Yulia, Cotter Amanda, Gaffney Geraldine, Devane Declan, Molloy Eleanor J, Murphy Deirdre J
Academic Department of Obstetrics and Gynaecology, The Coombe Hospital & Trinity College, University of Dublin, Dublin, Ireland.
Data Science Centre and the Department of General Practice, RCSI, Dublin, Ireland.
BJOG. 2025 Apr;132(5):557-564. doi: 10.1111/1471-0528.18068. Epub 2025 Jan 9.
To establish whether digital foetal scalp stimulation (dFSS) performs better than foetal blood sampling (FBS) in terms of reducing the rate of caesarean section (CS) in labour, without adversely affecting perinatal outcomes.
A multicentre parallel-group randomised controlled trial.
Maternity centres in Ireland.
The study aimed to randomise 2500 nulliparous women who required a second-line test of foetal well-being in labour due to abnormal cardiotocography (CTG).
Participants were randomly allocated to dFSS or FBS in a 1:1 ratio. Analysis was according to the published protocol and included a meta-analysis of the pilot study data and trial data.
The primary outcome was CS.
Due to lower-than-expected randomisations, the trial concluded early. Of 534 consented participants, 124 had a second-line test of foetal well-being in labour and 43 (34.7%) were randomised; 20 to dFSS and 23 to FBS. The rate of CS was 40.0% (8/20) in the dFSS group and 47.8% (11/23) in the FBS group (absolute difference 7.8%; OR 0.73, 95% CI 0.22-2.44). The rate of CS was lower in the dFSS group when the trial data were included in a meta-analysis with the pilot data (n = 50), although the confidence limits were wide (OR 0.41, 95% CI 0.17-0.96). There was no significant difference in rates of adverse perinatal and maternal outcomes. Of the nonrandomised participants who received a second-line test, 65% (53/81) received dFSS.
The small sample size limits the ability to conclude whether dFSS performs better as a second-line test of foetal well-being in labour than FBS. A clinician preference for dFSS was apparent, even though robust evidence is lacking.
This trial was prospectively registered on ClinicalTrials.gov on the 31st of March 2022.
gov Identifier: NCT05306756 (Access at https://clinicaltrials.gov/study/NCT05306756?cond=fetal%20blood%20sampling&rank=3).
确定在降低分娩剖宫产率方面，数字胎儿头皮刺激（dFSS）是否比胎儿血液取样（FBS）效果更好，且不对围产期结局产生不利影响。
多中心平行组随机对照试验。
爱尔兰的产科中心。
该研究旨在将2500名因产时胎心监护（CTG）异常而需要进行二线胎儿健康状况检测的初产妇随机分组。
参与者按1:1比例随机分配至dFSS组或FBS组。分析按照已发表的方案进行，包括对试点研究数据和试验数据的荟萃分析。
主要结局为剖宫产。
由于随机分组数量低于预期，试验提前结束。在534名同意参与的参与者中，124人在产时接受了二线胎儿健康状况检测，43人（34.7%）被随机分组；20人分到dFSS组，23人分到FBS组。dFSS组的剖宫产率为40.0%（8/20），FBS组为47.8%（11/23）（绝对差异7.8%；比值比0.73，95%置信区间0.22 - 2.44）。当将试验数据与试点数据（n = 50）纳入荟萃分析时，dFSS组的剖宫产率较低，尽管置信区间较宽（比值比0.41，95%置信区间0.17 - 0.96）。围产期和产妇不良结局发生率无显著差异。在接受二线检测的非随机分组参与者中，65%（53/81）接受了dFSS。
样本量较小限制了得出dFSS作为产时二线胎儿健康状况检测是否比FBS效果更好的结论的能力。尽管缺乏有力证据，但临床医生对dFSS的偏好明显。
该试验于2022年3月31日在ClinicalTrials.gov上进行前瞻性注册。
gov标识符：NCT05306756（可在https://clinicaltrials.gov/study/NCT05306756?cond=fetal% \ 20blood%20sampling&rank=3查询）。
