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临床试验/NCT03650972
NCT03650972Unknown不适用

Implementation of AFL Monitoring in Clinical (Lapsiveden Laktaattipitoisuuden Merkitys kliinisessä käytössä)

Turku University Hospital0 个研究点目标入组 200 人开始时间: 2018年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
Spontaneus Vaginal delivery

研究概览

简要总结

The overall objective of this randomized controlled trial is to develop a clinical standard procedure for measuring lactate in amniotic fluid (amniotic fluid lactate = = AFL) during childbirth before oxytocin stimulation is started. The aim is to reduce the need for emergency caesarean section during dysfunctional labour. The aim is also to study how different substances (oxytocin and Samarin®) affect uterine metabolic status during labour.

Labour dystocia, i.e. prolonged labour, occurs in up to 30% in primipara deliveries and in about 20% of all the deliveries. In 2016, in Finland oxytocin stimulation was used in 42% of all the deliveries.

The uterus, myometrium, is one of the largest muscles in the human body and consists mainly of smooth muscle cells. During the contractions the myometrial vessels also contract, causing momentary hypoxia and activation of anaerobic metabolism: O2 and pH levels of the muscle cell decreases and the lactate concentration increases. After the contraction, the blood circulation is restored and the anaerobic metabolites gradually dissolve. Myometrium requires a sufficiently long break between the contractions to recover. In dysfunctional labour the anaerobic metabolites accumulate in the myometrium. Accumulation of lactate has proved significantly to reduce the spontaneous contractions of myometrium and hinder myometrium calcium metabolism, which in turn reduces the strength of the contractions. Amniotic fluid lactate is known to reflect the metabolic state of the uterus during the labour.

Prolonged labour can in many aspects be compared to the athlete's tired muscles. Many of today's athletes try to control the accumulation of lactic acid in their muscles during training by drinking baking soda (bicarbonate) dissolved in water one hour before their physical activity. Bicarbonate is known to function as a lactic acid buffer. Bicarbonate is considered as food and is sold in grocery stores as baking soda and for example as Samarin®. Samarin® is safe to use during pregnancy because as a bicarbonate it does not pass through placenta and does not affect the fetus.

The trial aims to research if high AFL values (AFL > 12 mmol/L) in women with labour arrest are best treated by:

A) treating the labour according to the hospital's current guidelines during labour arrest, i.e. starting the stimulation with oxytocin and measuring the AFL again after one hour B) administering bicarbonate (Samarin®) dissolved in water one hour before starting the stimulation with oxytocin

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • gestational age at least 37 + 0 weeks
  • singleton pregnancy
  • cephalic presentation
  • active labor (regular painful contractions, effaced cervix open at least 3cm)
  • arrested labour progress according partogram and clinic guidelines

排除标准

  • intra uterine fetal growth retardation (> 22%)
  • intra uterine fetal death
  • threat of fetal asphyxia
  • severe vaginal bleeding
  • disproportion between the fetal head and the mother's pelvis
  • hypertonic contractions (more than 5 in 10 minutes)
  • known allergy or hypersensitivity to oxytocin or to any of derivatives
  • women who cannot understand the information of the study

研究组 & 干预措施

A, Non-bicarbonate

No Intervention

When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group A the labour is treated according to the hospital's current guidelines during labour arrest, i.e. the stimulation with oxytocin is started and AFL is measured again after one hour

B, Bicarbonate group

Active Comparator

When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group B the participant will drink bicarbonate (2 packages of Samarin®) dissolved in 200 ml of water. Then after one hour the AFL will be measured again and the stimulation with oxytocin will be started if there is no progress in the cervix.

干预措施: Samarin (Other)

结局指标

主要结局

Spontaneus Vaginal delivery

时间窗: by the end of the delivery

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Susanna Koski

Medical Doctor

Turku University Hospital

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