Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neonatal acidosis
研究概览
简要总结
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
详细描述
The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes.
The primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participants are randomly assigned a number (generated using an online random number generator) and given an opaque envelope containing instructions for study drug or placebo administration. The envelope will be opened by a nurse who prepared the injection in a treatment room, separated from the Labour Suite. The doctors managing the cases, the surgeons who performed the surgeries, the anaesthetists and the patients themselves were blinded against the injection given
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
- •term singleton pregnancy
- •cephalic presentation
- •in labour with cervix dilatation > 4cm and regular uterine contractions of 3 or more 10 min
- •abnormal fetal heart rate status diagnosed using standard electronic FHR according to NICE guideline (2014)
- •acceptance of participation by the signing of a written consent.
- •Exclusion Criteria
- •maternal cardiopathy
- •hyperthyroidism
- •abruptio placentae or other placental accidents
- •hypertensive disease of pregnancy
- •hyperstimulation with oxytocin
- •multiple gestation
- •abnormal fetus planned for conservative management
- •evidence of intrauterine growth restriction
- •patient on medication which will interact with terbutaline (tricyclic antidepressants, beta-blockers, diuretics and sympathomimetic medicine).
排除标准
- 未提供
研究组 & 干预措施
Control group
Placebo (normal saline) 0.5 mls , subcutaneously
干预措施: Terbutaline (Drug)
Intervention group
Terbutaline 0.5 mls (0.25 mg) , subcutaneously
干预措施: Terbutaline (Drug)
结局指标
主要结局
Neonatal acidosis
时间窗: within 1 hour of delivery
Umbilical artery acidosis
次要结局
- Neonatal Apgar score(5 minutes after delivery)
- Neonatal acid base status(within 1 hour of delivery)
- Neonatal intensive care unit admission(Within 24 hours of delivery)
- Maternal blood pressure(Within 1 hours after drug administration)
- Maternal heart rate(Within 1 hours after drug administration)
- Blood loss(Within 24 hours of delivery)
- Hematocrit change(Within 24 hours of delivery)
研究者
Zahar Azuar Zakaria
Principal investigator, Consultant Obstetrician
Hospital Kemaman