Efficacy of Bicarbonate on the Risk of Assisted Delivery in Danish Nulliparous Women With Prolonged Labour: a Double-blinded Parallel Randomized Controlled Trial (The ProLabour Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,520
- 试验地点
- 3
- 主要终点
- Difference in incidence of assisted delivery
研究概览
简要总结
The goal of this clinical trial is to learn if oral bicarbonate can treat prolonged labour in nulliparous women with prolonged labour.
The main question it aims to answer is: Do oral bicarbonate and restrictive oxytocin use reduce assisted delivery rate (emergency cesarean and vacuum/forceps delivery) in nulliparous women with prolonged labour.
Researchers will compare bicarbonate and placebo (a look-alike substance that contains no drug) to see if bicarbonate works to treat prolonged labour.
Participants will:
- drink bicarbonate or placebo
- have cervical dilatation reassessed after 2 hours. If still slow progression, they will follow standard protocol for oxytocin augmentation
- will receive a questionnaire 1 month post partum to assess birth experience
1/3 of participants will have amniotic fluid lactate measured at inclusion and after 2 hours
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The active substance, sodium bicarbonate, will be diluted in a glass of 200 ml soda water added flavour. Placebo consist of 200 ml soda water added the same flavor.
Bicarbonate/placebo will be prepared in another room by a person not involved in the specific labour. The person will give the drink directly to the woman. Amniotic fluid will be collected and analysed externally.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Danish or English speaking.
- •Cephalic presentation.
- •Gestational age ≥34+0 - <42+0 (days +weeks) at onset of labour.
- •Normal foetal heart rate pattern in the 20 minutes prior to inclusion.
- •Spontaneous onset of labour or non-medical induced labour (balloon catheter and/or artificial rupture of membranes).
- •Active first stage of labour confirmed, according to Danish national guidelines: Cervical dilatation at ≥4 - <10 cm with regular painful contractions.
- •Prolonged labour diagnosed, according to Danish national guidelines: Cervical dilatation progresses at less than 2 cm over a 4-hour period.
排除标准
- •Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated)
- •Significant medical comorbidity in the form of renal or heart condition, assessed case-by-case basis.
- •Serious obstetric complication
- •Known allergy or intolerance to sodium bicarbonate.
- •Ingestion of sodium bicarbonate in active labour prior to inclusion.
- •Current treatment with following medicines: Gabpabpentin, Tetracycline, Ketoconazole (NB! These medications are already generally advised contradicted against induring pregnancy)
研究组 & 干预措施
Sodium bicarbonate
Participants receive oral sodium bicarbonate 4.26 gram once.
干预措施: Sodium bicarbonate (Drug)
Placebo
Participants receive placebo once.
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in incidence of assisted delivery
时间窗: At birth
Defined as a composite of emergency caesarean section and instrumental vaginal delivery
次要结局
- Difference in adverse neonatal outcome(From birth until 7 days postpartum)
- Difference in total oxytocin dose(Intrapartum)
- Difference in epidural analgesia(Intrapartum)
- Difference in postpartum blood loss(From birth until 24 hours postpartum)
- Difference in women receiving tocolytics used during labour(Intrapartum)
- Difference in duration of active labour(Intrapartum)
- Difference in birth experience(One month postpartum)
- Difference in amniotic fluid lactate (AFL) concentration(Measured at inclusion and two hours later.)
- Difference in number of women getting antibiotics during labour(Intrapartum)
- Difference in intra- or postpartum infection(Intrapartum and until 7 days postpartum)
- Difference in number of 3rd or 4th-degree perineal tears(Within 2 hours after birth)
研究者
Nanna Maaløe
Associate Professor
Copenhagen University Hospital, Hvidovre