White Katharine O'Connell, Nucatola Deborah L, Westhoff Carolyn
Boston University School of Medicine, Boston, Massachusetts; and Planned Parenthood Federation of America and Columbia University, New York, New York.
Obstet Gynecol. 2016 Nov;128(5):1071-1076. doi: 10.1097/AOG.0000000000001671.
To compare the effectiveness of 1.0 mg intra-fetal or intra-amniotic digoxin to achieve fetal asystole before second-trimester surgical pregnancy termination.
In a randomized trial, women received 1.0 mg transabdominal intra-fetal or intra-amniotic digoxin on the day of laminaria placement before dilation and evacuation between 20 and 24 weeks of gestation. The primary outcome was incidence of fetal asystole, documented immediately before dilation and evacuation. We planned to analyze the primary outcome by original group assignment as well as by as-treated and per-protocol populations. A sample size of 270 was needed to detect an 8% difference in failure rates between groups. Prespecified secondary outcomes included the incidence of adverse events, side effects, and procedural differences.
Between January 2012 and January 2013, we screened 381 women and randomized 270 women to receive intra-fetal (n=136) or intra-amniotic (n=134) digoxin. Characteristics were similar across groups; the mean gestational age was 21.6 weeks (standard deviation 1.2). The proportion of fetal asystole was higher in the intra-fetal group (128/135 [94.8%]) than the intra-amniotic group (107/130, 82.3%; relative risk of failure to achieve asystole 3.41, 95% confidence interval 1.52-7.68). Results were similar in the as-treated and per-protocol populations. There were no significant differences in adverse events or side effects and no differences in injection duration, operative time, or estimated blood loss.
Administration of intra-fetal injection of digoxin led to a higher proportion of participants achieving fetal asystole within 24 hours than intra-amniotic injection.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01047748.
比较在孕中期手术终止妊娠前，经腹胎儿内或羊膜腔内注射1.0毫克地高辛使胎儿心脏停搏的有效性。
在一项随机试验中，妊娠20至24周的妇女在放置海藻棒准备扩张刮宫术当天，经腹接受1.0毫克胎儿内或羊膜腔内注射地高辛。主要结局是在扩张刮宫术前即刻记录的胎儿心脏停搏发生率。我们计划按原始分组以及按接受治疗和符合方案人群分析主要结局。需要270例样本量来检测组间失败率8%的差异。预先设定的次要结局包括不良事件、副作用的发生率以及操作差异。
2012年1月至2013年1月期间，我们筛查了3名妇女，将270名妇女随机分组，分别接受胎儿内注射地高辛（n = 136）或羊膜腔内注射地高辛（n = 134）。各组特征相似；平均孕周为21.6周（标准差1.2）。胎儿内注射组胎儿心脏停搏的比例（128/135 [94.8%]）高于羊膜腔内注射组（107/130，82.3%；未实现心脏停搏的相对风险为3.41，95%置信区间1.52 - 7.68）。在接受治疗和符合方案人群中的结果相似。不良事件或副作用无显著差异，注射持续时间、手术时间或估计失血量也无差异。
与羊膜腔内注射相比，经腹胎儿内注射地高辛使更多参与者在24小时内实现胎儿心脏停搏。
ClinicalTrials.gov，https://clinicaltrials.gov，NCT01047748 。
