Failed Instrumental Delivery Following Combined Clinical and Intrapartum Sonographic Assessment of the Fetal Head Position vs Conventional Labor Management: Propensity Score Matched Analysis of Prospective Data From an International Dataset
试验速览
- 阶段
- 不适用
- 入组人数
- 2,282
- 试验地点
- 1
- 主要终点
- Vaginal delivery
研究概览
简要总结
Instrumental delivery is performed in 3-15% of all births (1). Successful instrumental delivery avoids need for cesarean section with associated maternal surgical morbidity, risk from neonatal disimpaction and future pregnancy implications. However, instrumental birth carries risk of maternal perineal and anal sphincter injury, postpartum haemorrhage, shoulder dystocia and fetal trauma (2,3). Additionally, failure of instrumental birth requires delivery by cesarean section with a more deeply impacted fetal head, resulting in compounding of fetal and maternal risks (3,4). Therefore, appropriately identifying women that are at risk of failed instrumental birth is important to reduce maternal and neonatal morbidity.
Fetal head position and station are key determinants in success of instrumental birth, traditionally assessed with digital vaginal examination (1,5). There is now high quality evidence showing that intrapartum ultrasound is a more reliable tool in determining fetal head position and station compared to digital vaginal examination (6,7). Additionally, intrapartum ultrasound has been shown to predict outcome of instrumental birth and improve accuracy of instrument placement (8-11).
However, no randomised studies to date have demonstrated a benefit in maternal and neonatal morbidity from using intrapartum ultrasound, possibly due to being underpowered. Low recruitment of studies has been suggested to occur due to practitioners electing to use ultrasound rather than randomise participants, despite the absence of evidence supporting clinical benefit (13).
This study aims to evaluate whether the assessment of the fetal occiput position by intrapartum sonography before instrumental delivery improves labour outcomes by using an observational design with propensity score matching analysis.
This international multicentre prospective observational study will compare outcomes of two parallel groups:
- Group 1: patients submitted to instrumental delivery preceded by the use of ultrasound for the assessment of the occiput position by clinicians who routinely perform intrapartum sonography as an adjunct to clinical examination prior to vacuum delivery
- Group 2: patients having submitted to instrumental delivery without the adjunct of by clinicians not performing intrapartum sonography prior to vacuum delivery
The investigators will perform a propensity score (PS) matching analysis to assess the effect of US as an adjunct to clinical examination prior to instrumental delivery on the occurrence of failed instrumental delivery, adjusting for important differences in baseline characteristics between groups to reduce confounding bias. The investigators will assess two primary outcomes of vaginal delivery and composite adverse perinatal outcome in additional to maternal morbidity and instrumental failure rates.
详细描述
Introduction Instrumental delivery is commonly performed during the second stage of labor with the aim to expedite delivery in conditions of second stage dystocia or non-reassuring fetal condition and is estimated to account for approximately 3-15% of all births. The appropriate use of vacuum extractor and forceps is crucial to avoid unnecessary and potentially challenging second-stage caesarean sections, however a 4-6% failure rate has been reported following attempted instrumental delivery. When this occurs, caesarean section is required to deliver the fetus. However, caesarean section following failed instrumental delivery is acknowledged to be associated with an increased incidence of maternal and fetal complications including neonatal trauma, skull fracture, intracranial haemorrhage, neonatal acidaemia and transfer to NICU as well as postpartum haemorrhage, surgical injury and third- or fourth-degree perineal tears compared to a successful vacuum delivery.
The decision to expedite delivery by means of caesarean section during the second stage of labor has also been associated with maternal complications including uterine incision extension, incidental cystotomy and with an increased frequency of fetal injury. Therefore, the decision as to which intervention to perform is crucial to optimize the maternal and neonatal outcomes when an obstetric intervention is indicated during the second stage of labor.
Fetal head position and station are among the major determinants of successful instrumental delivery. Instrumental delivery is recommended following the ascertainment of the fetal head position when the station is below the level of the maternal ischial spines (level 0). A secondary analysis of a randomized controlled trial conducted on a group of women submitted to instrumental vaginal delivery has shown that the risk of failed vacuum extraction is increased in the event of inaccurate placement of the instrument, which is favoured by a high fetal station and a non-occiput anterior position - i.e. a malposition - of the fetal head. Fetal head position and station have been traditionally assessed by digital examination. However, such evaluation has been shown to yield limited accuracy and poor reproducibility. Akmal et al. compared the accuracy of vaginal examination versus transabdominal sonography in the ascertainment of the head position prior to instrumental delivery showing an overall 27% rate of misdiagnosis at vaginal examination, which was mainly accounted by cases in occiput posterior position and station at the level of the ischial spines. Wong et al conduced a randomized controlled trial (RCT) on 50 patients undergoing instrumental delivery by means of vacuum extractor due to second stage dystocia by measuring distance between the centre of the cignon and the flexion point between the cases submitted (n=25) and those not submitted (n=25) to intrapartum US in addition to the vaginal examination. The mean distance was lower in the patients submitted to intrapartum sonography in addition to clinical examination compared to those who had only vaginal examination (2.1+1.3 vs 2.8+1.0 cm, p<0.05).
Conversely, intrapartum sonography has been demonstrated to be a reliable tool for the assessment of the fetal head station and position, particularly in the second stage of labor. The transabdominal approach is considered the gold standard method for the diagnosis of the occiput position, while the transperineal approach is commonly used for the objective measurement of the fetal station. The US parameters have also been shown to be more accurate than clinical examination in predicting the outcome of instrumental vaginal delivery. On this basis, the International Guidelines endorse the use of intrapartum sonography in conditions of abnormal progression of the first or of the second stage of labor and in the event of uncertainty of the occiput position following vaginal examination prior to perform an instrumental delivery.
Hypothesis and Justification for the study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Non-anomalous singleton pregnancies
- •Cephalic presenting fetus
- •Gestational age > 36+0 weeks
- •Clinical indication for instrumental delivery
排除标准
- •Any contraindication to instrumental delivery
- •Maternal age <18 years
结局指标
主要结局
Vaginal delivery
时间窗: At time of successful birth of the neonate
Achieve delivery of the neonate vaginally via vacuum or forceps delivery
Composite adverse perinatal outcome
时间窗: up to 100 weeks after delivery
Occurrence of either shoulder dystocia, acidaemia (as defined by cord umbilical pH \<7.0 and/or a base excess \>12.0), Apgar score \<7 at 5 minutes, neonatal injury (intracranial haemorrhage, skull fracture), NICU admission, hypoxic-ischemic encephalopathy and death
次要结局
- Maternal morbidity(up to 100 weeks after delivery)
- Sequential instrumental delivery by forceps(up to 100 weeks after delivery)
