National Women's Health, Auckland City Hospital, Auckland, New Zealand.
Liggins Institute, The University of Auckland, Auckland, New Zealand.
BMJ Open. 2022 Sep 7;12(9):e062309. doi: 10.1136/bmjopen-2022-062309.
To assess the feasibility of conducting a randomised placebo-controlled trial of corticosteroids prior to planned caesarean section from 35 to 39 weeks.
A triple-blind, placebo-controlled, parallel, trial randomised at the participant level (1:1 ratio). Additional feasibility data obtained by questionnaires from trial participants and women who declined trial participation, and focus groups with local site researchers and clinicians.
Three obstetric units in New Zealand including tertiary and secondary care; public and private care, and research active and non-active units.
Women undergoing a planned caesarean section from 35 to 39 weeks; local site researchers and clinicians.
Two doses of 11.4 mg betamethasone or saline placebo. Questionnaires and focus group meetings.
Primary outcome: trial recruitment rate of eligible women.
trial recruitment by gestational age, site and delivery indication; proportion of babies who completed measurements of blood glucose concentrations as per protocol; overall incidence neonatal respiratory distress requiring >60 min of respiratory support; overall incidence of neonatal hypoglycaemia, and barriers and enablers to trial participation by participants, researchers and clinicians.
The recruitment rate was 8.9% (88/987) overall and 11.2% (88/789) for those approached about the trial. Neonatal blood glucose concentrations were measured as per protocol in 87/92 (94.6%) babies. For potential participants, key enablers to participation were contributing to research, a feeling of relevance and a good understanding; key barriers were a lack of understanding and concerns over safety. For researchers and clinicians, themes representing enablers and barriers included relevance, communication and awareness, influences on women's decision-making, resource challenges and trial process practicalities.
Some women are willing to participate in a randomised placebo-controlled trial of corticosteroids prior to a planned caesarean section birth at late preterm and term gestations. Participation in such a trial can be enhanced.
评估在 35 至 39 孕周计划行剖宫产术前使用皮质类固醇进行随机安慰剂对照试验的可行性。
一项三盲、安慰剂对照、平行、参与者水平随机（1:1 比例）试验。通过试验参与者和拒绝参与试验的女性的问卷调查以及与当地研究人员和临床医生的焦点小组获得额外的可行性数据。
新西兰的三个产科单位，包括三级和二级护理；公共和私人护理，以及研究活跃和非活跃的单位。
35 至 39 孕周计划行剖宫产术的女性；当地的研究人员和临床医生。
11.4mg 倍他米松或生理盐水安慰剂两次剂量。问卷和焦点小组会议。
主要结局：合格女性的试验招募率。
按胎龄、地点和分娩指征进行的试验招募；按方案完成血糖浓度测量的婴儿比例；需要>60 分钟呼吸支持的新生儿呼吸窘迫的总发生率；新生儿低血糖的总发生率，以及参与者、研究人员和临床医生对试验参与的障碍和促进因素。
总的招募率为 8.9%（88/987），而对于接受试验的女性，招募率为 11.2%（88/789）。按照方案，87/92（94.6%）的婴儿测量了新生儿血糖浓度。对于潜在的参与者，参与的主要促进因素是参与研究、相关性和良好的理解；主要障碍是缺乏理解和对安全性的担忧。对于研究人员和临床医生，代表促进因素和障碍的主题包括相关性、沟通和意识、对女性决策的影响、资源挑战和试验过程的实际性。
一些女性愿意在晚期早产和足月分娩前计划行剖宫产术时参与皮质类固醇的随机安慰剂对照试验。可以提高参与这种试验的意愿。
