Saether Elisabeth, Andersson Ola, Bjellmo Solveig, Bernitz Stine, Reinhart-Van Gülpen Friedrich, Myklebust Tor Åge, Stridsklev Solhild, Eriksen Beate Horsberg
Department of Obstetrics and Gynaecology, Clinic Ålesund, Møre and Romsdal Hospital Trust, Aalesund, Norway.
Faculty of Medicine and Health Sciences, Department of Clinical and Molecular Medicine, Trondheim, Norway , Norwegian University of Science and Technology, Trondheim, Norway.
BMC Pregnancy Childbirth. 2025 May 9;25(1):550. doi: 10.1186/s12884-025-07641-w.
Keeping the umbilical cord intact the first minutes after delivery is beneficial for both term and preterm infants. However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS.
The intervention development process (phase 1) covered: (A) placenta delivery without cord clamping, (B) intact-cord stabilisation of the infant and (C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback rounds. The involved staff were trained prior to pilot-testing (phase 2). Women having a CS in regional anaesthesia, expecting a term or near-term singleton infant were included in the pilot-study after written consent. Primary outcome was the proportion of successfully completed interventions. For assessment of safety, maternal estimated intraoperative blood loss, infant 5-minute Apgar scores and infant rectal temperature during stabilisation were compared to pre-defined accept criteria. Dry-electrode ECG (NeoBeat™) was used for early detection of infant heart rate. Any respiratory support was registered. Early skin-to-skin contact between mother and infant was attempted for vigorous infants.
A detailed intervention protocol was developed and tested. Twenty-nine mother-infant-dyads were included in the pilot study. Gestational age ranged from 37 to 42 weeks. The intervention was successfully completed in 26 of 29 cases, of which 31% were planned CS. Median (SD) infant heart rates at one and five minutes were 159 (32) and 168 (21) beats per minute respectively. Eight infants (28%) had intact-cord respiratory support. One infant had a 5-minute Apgar score < 7 and three infants (10%) had rectal temperatures below 36.5 °C during the first 10-15 min after birth. Three mothers (10%) had estimated intraoperative blood loss > 1000 ml.
Extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for term and near-term infants delivered by CS was feasible according to predefined accept criteria. Further investigation of safety of this complex intervention in larger, comparative studies is warranted.
Regional Committee for Medical Research Ethics Central Norway (REK-Midt), #399101.
分娩后最初几分钟保持脐带完整对足月儿和早产儿均有益。然而，在剖宫产（CS）中，由于缺乏可移动的复苏设备、难以维持无菌状态或担心产妇失血过多，这可能具有挑战性。本研究的目的是开发并初步测试剖宫产中婴儿的宫外胎盘输血及脐带完整稳定技术。
干预措施开发过程（第1阶段）包括：（A）不夹脐带娩出胎盘，（B）稳定婴儿的脐带完整状态，以及（C）基于生理学的脐带钳夹。通过现场模拟测试不同场景，并经过多轮反馈进行调整。参与的工作人员在初步测试（第2阶段）前接受了培训。在获得书面同意后，将接受区域麻醉、预计分娩足月或近足月单胎婴儿的剖宫产妇女纳入初步研究。主要结局是成功完成干预措施的比例。为评估安全性，将产妇估计的术中失血量、婴儿5分钟阿氏评分以及稳定过程中婴儿的直肠温度与预先确定的可接受标准进行比较。使用干电极心电图（NeoBeat™）早期检测婴儿心率。记录任何呼吸支持情况。对于活力良好的婴儿，尝试让母婴尽早进行皮肤接触。
制定并测试了详细的干预方案。29对母婴纳入了初步研究。孕周范围为37至42周。29例中有26例成功完成了干预，其中31%为计划剖宫产。1分钟和5分钟时婴儿心率的中位数（标准差）分别为每分钟159次（32次）和168次（21次）。8例婴儿（28%）接受了脐带完整状态下的呼吸支持。1例婴儿5分钟阿氏评分<7分，3例婴儿（10%）在出生后最初10 - 15分钟内直肠温度低于36.5°C。3例母亲（10%）估计术中失血量>1000 ml。
根据预先确定的可接受标准，对剖宫产分娩的足月和近足月婴儿进行宫外胎盘输血以促进脐带完整稳定及基于生理学的脐带钳夹是可行的。有必要在更大规模的对照研究中进一步调查这种复杂干预措施的安全性。
挪威中部医学研究伦理区域委员会（REK - Midt），编号#399101。
