Singh Natasha, Shah Nishel Mohan, Sooranna Gavin, Bourke Miriam, Yulia Angela, Battersby Cheryl, Tribe Rachel M, Johnson Mark R
Directorate of Women and Children, Department of Metabolism, Digestion and Reproduction, Chelsea and Westminster Hospital London, Imperial College London, London, UK.
Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, Chelsea & Westminster Hospital, 369 Fulham Road, London, SW10 9NH, UK.
BMC Pregnancy Childbirth. 2025 Mar 27;25(1):357. doi: 10.1186/s12884-025-07488-1.
Progesterone is known to maintain uterine quiescence as pregnancy advances. Recently, its efficacy in preventing preterm birth has been questioned prompting a search for an alternative treatment option. Cyclic AMP has been shown invitro to act in synergy with progesterone to maintain uterine quiescence.
We undertook an open label randomised feasibility study to test the hypothesis that the addition of aminophylline to the standard of care (SoC) is acceptable and can be tolerated in pregnant women at high risk of spontaneous preterm labour (sPTL). Women at high risk of sPTL, who met the inclusion criteria were invited to participate and randomised to receive the SoC (progesterone alone, n = 33) or treatment with the SoC and aminophylline (n = 37). The main outcome measure was to assess the how many women at high-risk of sPTL tolerated and continued to take aminophylline. Data were analysed using Graphpad Prism 8.0c (Graphpad Software, San Diego, CA, USA).
We found that of the addition of aminophylline was well tolerated in 30 of the 33 (91%) of women who continued in the combined arm, without any additional adverse maternal or fetal outcomes. 58% of eligible women agreed to participate in the study. The compliance rate was high at 99.42% +-0.82%. 67% of the women completed the post study questionnaire and all stated their willingness to take aminophylline if it were offered routinely for the prevention of sPTL.
The addition of aminophylline to the SoC is acceptable to women at high-risk of sPTL confirming that a randomised trial of aminophylline to reduce preterm delivery in women at high-risk of PTL is feasible.
Clinical trial gov NCT03152942. Date of full registration: 15/5/2017. https://clinicaltrials.gov/ct2/show/NCT03152942?cond=NCT03152942%26;draw=2%26;rank=1 .
众所周知，随着孕期进展，孕酮可维持子宫静息状态。最近，其预防早产的疗效受到质疑，这促使人们寻找替代治疗方案。已有研究表明，环磷酸腺苷（cAMP）在体外可与孕酮协同作用以维持子宫静息状态。
我们开展了一项开放标签随机可行性研究，以检验以下假设：对于有自发性早产（sPTL）高风险的孕妇，在标准治疗（SoC）基础上加用氨茶碱是可接受的且能耐受。符合纳入标准的有sPTL高风险的女性被邀请参与研究，并随机分为接受SoC（仅使用孕酮，n = 33）或接受SoC加氨茶碱治疗（n = 37）。主要结局指标是评估有sPTL高风险的女性中，有多少人能耐受并继续服用氨茶碱。使用Graphpad Prism 8.0c（Graphpad软件，美国加利福尼亚州圣地亚哥）对数据进行分析。
我们发现，在联合治疗组中持续治疗的33名女性中有30名（91%）对加用氨茶碱耐受性良好，且未出现任何额外的母体或胎儿不良结局。58%的符合条件女性同意参与研究。依从率很高，为99.42%±0.82%。67%的女性完成了研究后问卷，所有女性均表示如果氨茶碱能常规用于预防sPTL，她们愿意服用。
对于有sPTL高风险的女性，在SoC基础上加用氨茶碱是可接受的，这证实了一项关于氨茶碱减少PTL高风险女性早产的随机试验是可行的。
Clinical trial gov NCT03152942。完整注册日期：2017年5月15日。https://clinicaltrials.gov/ct2/show/NCT03152942?cond=NCT03152942%26;draw=2%26;rank=1 。
