Fetal Scalp Stimulation (FSS) Versus Fetal Blood Sampling (FBS) to Assess Fetal Wellbeing in Labour - a Multi-centre Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Caesarean section (CS)
研究概览
简要总结
Pregnant women have routine monitoring of the baby's heart rate when in labour. Women with complicated pregnancies require continuous monitoring using an electronic recorder called a CTG. The CTG produces a paper based recording which is interpreted by the midwife as showing normal, suspicious or abnormal features of the baby's heart rate. Babies quite commonly demonstrate abnormal features from time to time during the course of labour. In some cases the abnormal features are of sufficient concern to warrant delivery by emergency caesarean section. In most of these cases the baby is born in good condition and the question arises whether the caesarean section was unnecessary. In order to reduce the chance of an unnecessary caesarean section additional "second-line" tests can be offered. One such test is where a small drop of blood is taken from the baby's scalp. This test involves an internal examination with an instrument to visualise the baby's head and a small scratch to the baby's scalp. The blood is tested for acid which is an indicator of whether or not the baby is receiving enough oxygen. The test is called a fetal blood sample or FBS. An alternative test is where the doctor or midwife performs a vaginal examination with two fingers and gently rubs the baby's scalp in an attempt to cause an increase in the baby's heart rate. This is a healthy response suggesting that the baby is receiving enough oxygen. The test is called digital fetal scalp stimulation or dFSS. These two "second-line" tests have never been compared in a properly conducted head-to-head comparison. This study aims to compare dFSS and FBS in a large clinical trial completed within four of Ireland's largest maternity hospitals. This trial will generate important evidence of direct relevance to clinical care and patient outcomes.
详细描述
Continuous electronic fetal heart rate recording with cardiotocography (CTG) is a standard approach to monitoring fetal wellbeing in labour and is recommended for high-risk pregnancies. The aim is to identify fetal compromise early and intervene in order to reduce serious adverse events such as cerebral palsy and perinatal death. CTG abnormalities are relatively common and can lead to the decision to deliver by emergency caesarean section. In most cases the fetus is subsequently found to have been compensating for the stress of labour and is not actually compromised. Fetal blood sampling (FBS) is a second-line invasive test that provides information on the acid-base status of the fetus, reflecting hypoxia. It is used to provide either reassurance that labour can continue, or more objective evidence that delivery needs to be expedited. Clinical guidelines in the United Kingdom and Ireland have treated FBS as a gold standard test. Recent studies have questioned the validity and reliability of FBS, and also the logistic challenges of achieving a result in a timely manner. Fetal scalp stimulation (dFSS) by digital rubbing is an alternative less invasive test of fetal wellbeing in labour and is recommended in preference to FBS in US guidelines. This research aims to compare digital FSS and FBS in women with term singleton pregnancies and an abnormal intrapartum CTG, where additional information on fetal wellbeing is required. A multi-centre randomised controlled trial will be conducted. The clinical outcomes of interest will include caesarean section, assisted vaginal birth, low Apgar scores, cord blood acidosis, and admission to the neonatal unit. This trial will generate important evidence of direct relevance to clinical care and patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary and perinatal secondary outcomes will be recorded from the computerised delivery record without knowledge of the allocation.
The principal investigator will play no role in the care of the patient or assessment of outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women
- •Singleton pregnancy
- •Cephalic presentation
- •Gestational age 37+0 weeks or greater
- •Abnormal CTG that requires second-line testing (FBS or dFSS)
排除标准
- •Contraindication to FBS
- •Limited understanding of English
- •At the discretion of the responsible obstetrician in cases where there is urgency
结局指标
主要结局
Caesarean section (CS)
时间窗: at birth
All caesarean sections will be in labour in the context of an abnormal CTG
次要结局
- Spontaneous Vaginal Birth (SVB)(at birth)
- Apgar score at 5 minutes <7(age 5 minutes)
- Decision Delivery Interval (DDI) for AVB >15 minutes(during labour up until time of birth)
- Assisted vaginal birth, primary indication poor progress(at birth)
- Abnormal neurological examination prior to discharge(at time of hospital discharge, assessed up to 28 days after birth)
- Major obstetric haemorrhage >1000mL(up to 24 hours after birth)
- Obstetric Anal Sphincter Injury (OASI - all degrees)(at birth)
- Perinatal death(up to 7 days of age)
- Caesarean section, primary indication poor progress(at birth)
- Caesarean section, failed attempt at assisted vaginal birth(at birth)
- Assisted vaginal birth, primary indication fetal concerns(at birth)
- Late perinatal death(8-28 days of life)
- pH umbilical artery <7.00 or Base Excess artery <-12.0(immediately after birth)
- Admission to neonatal unit (NNU)(from birth up until 28 days)
- Therapeutic hypothermia(indicated within 6 hours of birth)
- Caesarean section , primary indication fetal concerns(at birth)
- Assisted vaginal birth (AVB) (all cases)(at birth)
- Decision Delivery Interval (DDI) for emergency CS >30 minutes(during labour up until time of birth)
- Number of inconclusive/uninterpretable dFSS procedures(during labour up until birth)
- Neonatal encephalopathy (as defined by authors)(from birth up until 28 days)
- Maternal acceptability of procedure (defined by questionnaire)(from birth up to 7 days after birth)
- FBS related injury/complication to baby (as reported on neonatal examination)(at birth or with first 7 days of life)
- Referral to perinatal mental health services(from birth up to six weeks after birth)
- Number of second-line tests (dFSS or FBS)(during labour up until birth)
- Number of failed FBS procedures(during labour up until birth)
研究者
Deirdre J Murphy
Professor of Obstetrics
University of Dublin, Trinity College