Ultrasound Prediction of Persistent Occiput Posterior Position in Active Labor: a Multicentric Prospective Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 593
- 主要终点
- the incidence of POPP in the study population
研究概览
简要总结
Persistent occiput posterior position (POPP) represents a relevant risk factor for various adverse outcomes: prolonged labor, higher incidence of operative delivery and/or cesarean section for non-reassuring fetal conditions, higher incidence of high-grade perineal tears (OASIS). For such reasons, labor with POPP needs particular and non-routinary attention.
Hence, it is important to diagnose in advance fetuses who present POPP to assure more adequate assistance in labor. Furthermore, digital examination shows a lower detection rate for such condition if compared to ultrasound in labor.
This multicenter prospective cross-sectional interventional study aims to evaluate the occiput position and the descent of the fetal head at the beginning of active labor to predict POPP at delivery. All the participants will be subjected to transabdominal and transperineal ultrasound at the beginning of active labor (between 3 and 8 cm of cervical dilatation) to evaluate the position of the fetal head and its descent. At the delivery, the position of the fetal head and the features of the second stage of the labor will be recorded.
详细描述
Background and rationale Occiput posterior position (OP) is the most common fetal malposition during labor. Such anomaly shows a correlation with higher risk of operative delivery and cesarean section, prolonged labor duration, neonatal morbidity, high-grade perineal lacerations. It is estimated that around 15-30% of fetuses in cephalic presentation start the labor in OP. Of these, 10-15% remain OP at full cervical dilatation, but only 5-8% remains in persistent OP position (POPP) at delivery, especially in nulliparous women.
The importance of knowing the precise position of the fetal head is related to the possible adverse outcome that POPP carries, requiring adequate surveillance during labor and delivery. The non-routinary surveillance consist of:
- Continuous non intermittent monitoring of fetal wellbeing (with cardiotocography)
- Rationalization of peridural anesthesia doses, due to prolonged labor
- Maternal position during labor facilitating descent and rotation of the fetal head
- Active cure of the perineum to reduce the risk of high-grade perineal tears.
In case of operative delivery, knowing the exact position of the fetal occiput ensure a better positioning of the vacuum extractor.
Ultrasound in labor ward demonstrated a higher performance compared to routine care (vaginal examination) in diagnosing fetal occiput position. Various approaches have been described to induce fetal head rotation: manual or instrumental intrauterine attempts, or maternal position changes (without any strong evidence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Age ≥18 y.o.;
- •Pregnant women with diagnosis of active labor, admitted to delivery room;
- •Singleton;
- •At term (>37 weeks);
- •Cephalic presentation;
- •Signed written informed consent to study participation.
排除标准
- •• Age <18 y.o.;
- •Preterm deliveries;
- •Multiple pregnancies;
- •Elective cesarean section;
- •Non-cephalic presentation;
- •Incomplete obstetrical data;
- •Refusal to provide informed consent.
结局指标
主要结局
the incidence of POPP in the study population
时间窗: 1 year
How many POPP in labor
次要结局
未报告次要终点
研究者
Familiari Alessandra
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS