引言在22周之前,在早发性胎儿肾脏羊水过多的孕妇中,进行连续羊膜输注以维持羊水的最佳方案尚不清楚。我们比较了两种不同方法的性能。方法在肾脏发育不全胎儿治疗(RAFT)试验的外部试点和可行性阶段,对单个中心进行的系列羊膜输注进行了二次分析。在外部飞行员期间,较高的羊膜输注量的频率较低;在可行性研究中,较小体积的羊膜输注更频繁.程序细节,并发症,使用分类变量的Pearson卡方检验或Fisher精确检验,连续变量的Studentt检验或Wilcoxon秩和检验,比较两组之间的产科结局。通过多变量重复测量逻辑回归模型获得程序细节与绒毛膜羊膜分离之间的校正关联。结果11名参与者接受了159次羊膜输注(外部飞行员:3名患者,21次羊膜输注;可行性:8例,138羊膜输注)。外部试点参与者的羊膜输注较少(7与19.5在可行性小组中,p=0.04),更大的羊膜输注量(750vs.500mL,p<0.01),羊膜输注之间的间隔更长(6[4-7]与4[3-5]天,p<0.01)。在外部飞行员中,绒毛膜羊膜分离更常见(28.6%vs.5.8%,p<0.01),羊膜输注开始后早产胎膜破裂(PPROM)发生较早(28±21.5vs.75.6±24.1天,p=0.03),第一次和最后一次羊膜输注之间维持羊水的持续时间较短(38±17.3vs.71±19天,p=0.03),与可行性小组相比。而分娩胎龄相似(35.1±1.7vs.33.8±1.5周,p=0.21),可行性参与者维持羊水的时间更长。结论由于PPROM的延迟发生,小量系列羊膜输注更频繁地维持正常羊水体积更长。
BACKGROUND: The optimal protocol for serial amnioinfusions to maintain amniotic fluid in pregnancies with early-onset fetal renal anhydramnios before 22 weeks is not known. We compared the performance of two different approaches.
METHODS: A secondary analysis was conducted of serial amnioinfusions performed by a single center during the external pilot and feasibility phases of the Renal Anhydramnios Fetal Therapy (RAFT) trial. During the external pilot, higher amnioinfusion volumes were given less frequently; in the feasibility study, smaller volume amnioinfusions were administered more frequently. Procedural details, complications, and obstetric outcomes were compared between the two groups using Pearson\'s χ2 or Fisher\'s exact tests for categorical variables and Student\'s t tests or Wilcoxon rank-sum tests for continuous variables. The adjusted association between procedural details and chorioamniotic separation was obtained through a multivariate repeated measure logistic regression model.
RESULTS: Eleven participants underwent 159 amnioinfusions (external pilot: 3 patients, 21 amnioinfusions; feasibility: 8 patients, 138 amnioinfusions). External pilot participants had fewer amnioinfusions (7 vs. 19.5 in the feasibility group, p = 0.04), larger amnioinfusion volume (750 vs. 500 mL, p < 0.01), and longer interval between amnioinfusions (6 [4-7] vs. 4 [3-5] days, p < 0.01). In the external pilot, chorioamniotic separation was more common (28.6% vs. 5.8%, p < 0.01), preterm prelabor rupture of membranes (PPROM) occurred sooner after amnioinfusion initiation (28 ± 21.5 vs. 75.6 ± 24.1 days, p = 0.03), and duration of maintained amniotic fluid between first and last amnioinfusion was shorter (38 ± 17.3 vs. 71 ± 19 days, p = 0.03), compared to the feasibility group. While delivery gestational age was similar (35.1 ± 1.7 vs. 33.8 ± 1.5 weeks, p = 0.21), feasibility participants maintained amniotic fluid longer.
CONCLUSIONS: Small volume serial amnioinfusions performed more frequently maintain normal amniotic fluid volume longer because of delayed occurrence of PPROM.