Puertas Alberto, Góngora Javier, Valverde Mercedes, Revelles Laura, Manzanares Sebastian, Carrillo M Paz
Department of Obstetrics and Gynecology, Virgen de las Nieves University Hospital of Granada, Avda. Fuerzas Armadas s/n, 18014 Granada, Spain.
Department of Obstetrics and Gynecology, Hospital de Poniente, Almería, Spain.
Eur J Obstet Gynecol Reprod Biol. 2019 Mar;234:213-217. doi: 10.1016/j.ejogrb.2019.01.023. Epub 2019 Jan 30.
Randomized studies have obtained conflicting results regarding the usefulness of fetal electrocardiographic (ECG) ST-segment analysis, possibly because these studies included non-homogeneous populations. We designed a study to determine whether this monitoring technique is potentially useful for populations at risk for fetal heart rate alterations during labor, i.e. groups of women who share late-term pregnancy as a risk factor.
This randomized clinical trial recruited women whose pregnancy had lasted more than 290 days. The participants were randomly assigned to continuous fetal cardiotocographic monitoring alone (CTG group) or with fetal ECG ST-segment analysis (ECG-F group). In the CTG group fetal heart rate was interpreted according to guidelines from the National Institute of Child Health and Human Development, whereas in the ECG-F group the tracings were interpreted according the original International Federation of Gynecology and Obstetrics (FIGO) guidelines. The primary outcome measure was neonatal outcome, evaluated as arterial blood pH in neonates after abdominal or vaginal operative delivery indicated because of nonreassuring fetal status.
A total of 237 women were randomized, of whom 200 were included in the final analysis (100 in each group). The rate of cesarean delivery was the same in both groups (26%), and the rate of operative delivery due to nonreassuring fetal status did not differ significantly (38% in the CTG group vs. 39% in the ECG-F group). Regarding neonatal outcomes, there was no significant difference between groups in neonatal pH (7.27 [7.23-7.29] and 7.25 [7.21-7.27]).
In a population comprising only late-term pregnancies, fetal ECG monitoring had no benefits for the mother or fetus. Additional studies are needed of protocols for using ST waveform analysis in selected population groups.
关于胎儿心电图（ECG）ST段分析的实用性，随机研究得出了相互矛盾的结果，这可能是因为这些研究纳入的人群并不同质。我们设计了一项研究，以确定这种监测技术对于分娩期间有胎儿心率改变风险的人群（即把晚期妊娠作为风险因素的女性群体）是否具有潜在的实用性。
这项随机临床试验招募了妊娠超过290天的女性。参与者被随机分配至仅进行连续胎儿心动图监测组（CTG组）或同时进行胎儿心电图ST段分析组（ECG - F组）。在CTG组，根据美国国立儿童健康与人类发展研究所的指南解读胎儿心率，而在ECG - F组，根据原国际妇产科联合会（FIGO）的指南解读记录。主要结局指标是新生儿结局，以因胎儿状况不佳而进行腹部或阴道手术分娩后新生儿的动脉血pH值来评估。
共有237名女性被随机分组，其中200名纳入最终分析（每组100名）。两组剖宫产率相同（26%），因胎儿状况不佳而进行手术分娩的比例无显著差异（CTG组为38%，ECG - F组为39%）。关于新生儿结局，两组新生儿pH值无显著差异（分别为7.27[7.23 - 7.29]和7.25[7.21 - 7.27]）。
在仅包含晚期妊娠的人群中，胎儿心电图监测对母亲或胎儿均无益处。需要针对特定人群组使用ST波形分析的方案进行更多研究。
