Continued Versus Discontinued Oxytocin Stimulation of Labour in a Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 10
- 主要终点
- Caesarean section
研究概览
简要总结
Background:
The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce labour. The hypothesis to be studied is that once the active phase of labour has commenced, Syntocinon® can be discontinued and the labour process will continue.
Design:
Double-blind randomised controlled multicentre trial
Setting:
Aarhus University Hospital, Denmark and Regional Hospital of Randers, Denmark
Population:
1200 women (600 in each group) stimulated in the latent phase of labour with oxytocin for induction
Methods:
The Syntocinon® infusion will be replaced with either continuous isotonic saline (placebo) or Syntocinon® infusion (control group), when the active phase of labour is reached.
Main outcome measures:
Caesarean section (primary outcome), tachysystole, neonatal asphyxia, birth experience
Perspective:
Syntocinon® is on the list high-alert medications and associated with complications for mother and child during labour. Reducing the duration of stimulation during labour may lower the number of asphyxial sequelae and the number of caesarean sections.
详细描述
Randomisation:
When the orificium ≥6 cm, regular painful contractions (≥3 per 10 minutes) and rupture of membranes participants will be randomised in a 1:1 ratio to either the control (continued Syntocinon®) or intervention (discontinued Syntocinon®) group using an Internet-based randomisation programme. The randomisation can only be performed when the woman consents to participation. Written consent can be given after the commencement of the Syntocinon® infusion, provided the woman previously has received sufficient information for her to give properly informed consent. Random block-sizes of 8 are used, and the participants will be stratified by site (Aarhus University Hospital, Randers Regional Hospital, Aalborg University hospital, or Sygehus Lillebælt Kolding), parity (nulliparous or parous) and indication for Syntocinon® infusion (induction or induction due to premature rupture of membranes).
The randomisation number corresponds to number of the project medicine (ampoule). The personnel of the delivery ward will administer the ampoules according to existing guidelines concerning medicine administration
Oxytocin stimulation protocol:
Existing national procedures prior to stimulation will be followed, including use of the existing checklists. No further examination will be done prior to inclusion and stimulation, no blood samples nor ECG to identify e.g. unknown QT-syndrome will be performed as this is never performed as a standard procedure prior to induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin)
排除标准
- •Unable to read and understand the Danish language or to give informed consent
- •Cervical dilatation > 4 cm
- •Non-cephalic presentation
- •Multiple gestation
- •Pathological fetal heart rate pattern (cardiotocogram, CTG) before Syntocinon® initiation
- •Fetal weight estimation > 4500 g (clinical or ultrasonic)
- •Subject declines participation
- •Gestational age less than 37 completed weeks
- •Definition: Stimulation with Syntocinon® following Premature Rupture of membranes (PROM) is induction of labour if there is no cervical change prior to starting the infusion, whereas stimulation with Syntocinon after PROM but following the establishment of significant cervical change is augmentation.
研究组 & 干预措施
Continued group
Recieve routine treatment with oxytocin according to the danish national guidelines.
干预措施: Oxytocin (Drug)
discontinued group (placebo)
The routine treatment with oxytocin will be discontinued and replaced with isotonic saline, when the active phase of labour is established.
干预措施: Placebo (Drug)
结局指标
主要结局
Caesarean section
时间窗: labour
Frequency of acute performed caesarean sections
次要结局
- Total duration of labour(0-48 hours)
- Uterine tachysystoli(0-48 hours)
- Volume of blood loss at delivery and postpartum(0-48 hours)
- Instrumental delivery(0-48 hours)
- Duration of the active phase of labour(0-48 hours)
- Need for evacuation of retained products of conception(0-48 hours)
- Neonatal use of antibiotics - postpartum(0-48 hours)
- Neonatal hyperbilirubinaemia(0-48 hours)
- Neonatal admission(0-48 hours)
- Birth experience(4 weeks postpartum)
- Dose and duration of oxytocin infusion(0-48 hours)
- Rupture of the anal sphincter(0-48 hours)
- Maternal readmission(0-168 hours)
- Retention of urine(0-48 hours)
- Apgar score at 1 and 5 minutes(0-48 hours)
- Need for resuscitation/ventilation of the newborn(0-48 hours)
- Neonatal death(0-7 days)
- Time of birth of placenta(0-2 hours)
- Cause of maternal readmission(0-7 days)
- Breastfeeding(0-6months)
- Use of episiotomy(0-48 hours)
- Vaginal explorations(0-48 hours)
- Cardiotocogram (CTG) classification(0-48 hours)
- Uterine hyperstimulation(0-48 hours)
- Maternal use of antibiotics during labour(0-48 hours)
- Use of epidural analgesia(0-48 hours)
- Uterine rupture(0-48 hours)
- Fetal scalp pH values or Fetal scalp lactate(0-48 hours)
- Umbilical cord arterial pH(0-48 hours)