跳至主要内容
临床试验/NCT04009993
NCT04009993Unknown不适用

A-BIRTHPERFORM Versus Conventional Partogram in the Improvement of Birth Results: a Randomized Controlled Trial

Hospital del Mar0 个研究点目标入组 969 人开始时间: 2020年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
969
主要终点
Incidence of non-spontaneous vaginal births

研究概览

简要总结

Midwives and Obstetricians when assisting women during labour do not follow the clinical guidelines on labour process care,in many cases oxytocin is used routinely without medical indication, and ends in the erroneous use of oxytocin, and risk of labour dystocia arise. In Spain, according to the National Health System the rate of oxytocin use during labour is 53.3%, in pregnant women with spontaneous onset of labour, which is high and is far from the expected standard (expected standard of 5 to 10%, as an indicator of good practice). The partogram is one of the conventional obstetric tools used in labour wards, specially the World Health Organization partogram with the four-hours action line, which is widely used and it serves to give a graphic content and a global vision of the evolution and medication given in a concrete women in labour, although a routine use of partogram is not recommended, and new studies are needed to stablish the effectiveness of the partograph. There are frequent professional errors using conventional partogram and this justify the need for a tool different from the usual ones. The algorithm of care in normal and in disrupted labour recommended by The National Institute for Health and Clinical Excellence (NICE) guidelines is complex.

The tool the investigators have designed is A-BIRTHPERFORM digital tool for professionals and consists in helping applying the Intrapartum Care´s NICE Guidelines algorithms to help decision-making.

Objective: The aim of the study will be to analyze if the use of A-BIRTHPERFORM contributes to improve perinatal results by reducing instrumental deliveries and caesarean sections.

Methods: Design: randomized controlled trial. Participants: The study will be conducted in 4 maternity hospitals of different autonomous communities of Spanish. Participants will be women from 18 to 41 years of age, pregnant at term between 37 and 41 weeks gestation, with spontaneous onset of labour or induced labour and with low or medium obstetric risk. Participants will be randomized to receive professional care during delivery using A-BIRTHPERFORM or assigned to conventional partogram care. The control group will be subject to traditional care through the use of conventional partogram used in each hospital following the labour care guidelines of each participant hospital. The experimental group will be cared by professionals using A-BIRTHPERFORM during the whole labour process.

Discussion: A-BIRTHPERFORM could help improve the use of NICE Guidelines on Intrapartum Care, and could help reducing the use of oxytocin, decreasing instrumented deliveries and severe perineal lacerations. The digital tool aims to provide standardization and systematization to childbirth care and to serve as a communication tool between team members.

This tool could allow the professional to freely access it from any digital device, not necessarily located at the counter or reception of the maternal unit, which facilitates personal reflection on labour progress and with the team, in order to improve health results for women and their families.

详细描述

Stimulation of labour with synthetic oxytocin is increasingly used all over the world. Synthetic oxytocin is used in cases of dystocia of labour, with the objective of attempting labour progression until achieving vaginal birth. The use of oxytocin could have potential adverse effects on the mother and the fetus, such as uterine tachysystole, which can lead to uterine rupture and fetal distress . There is a risk of fetal hypoxemia and acidemia if the contractions are very frequent and prolonged. The risk of instrumented delivery is even higher when oxytocin is used when labour is progressing normally. There is a significant association between oxytocin use to stimulate labour and severe perineal lacerations, postpartum urinary retention, postpartum hemorrhage and delayed onset of breastfeeding. The World Health Organization (WHO) defines dystocia of labour as four hours without progress during the active labor and is recommended to medically intervene . When health professionals that assist women in labour (Midwives and Obstetricians) do not follow the clinical guidelines on intrapartum care, labour dystocia and oxytocin use, and oxytocin is used routinely without medical indication, ends in the erroneous use of oxytocin. According to the evaluation of Strategy of Attention to Normal Childbirth (SANC), the National Health System in Spain, which sets standards of quality in obstetric practice, showed a rate of 53.3% of oxytocin use during labor in pregnant women with spontaneous onset of labour, which is high and is far from the expected standard (expected standard of 5 to 10%, as an indicator of good practice).

According to the Romano and de Lothian study, a high use of oxytocin during labour would be related to the so-called "cascade of interventions", referring to different obstetric interventions that are used routinely and not based on scientific evidence which could interfere in the physiology of childbirth and in the skills of women to cope with labour and labour pain. The use of oxytocin has a limited and uncertain benefit , and may even be harmful in some specific situations during labor. Lothian suggests in his study that routine practices that are unnecessary in physiological births should be avoided, thus minimizing complications, and improving perinatal outcomes.

An international consensus was published in 2017 to review the scientific evidence on care practices that facilitate a physiological delivery process and its relationship with the improvement of perinatal outcomes and maternal satisfaction.

The increase in the use of oxytocin during childbirth in healthy women and with spontaneous onset of labour seems to be generalized worldwide, and national and international agencies demand an improvement in the care provided during childbirth in women with pregnancies of low obstetric risk, with the objective of limiting unnecessary interventions during childbirth and birth.

In the same line, in 2018 an international initiative for childbirth (ICI) is promoted with 12 steps towards a safe and respectful Mother-Family motherhood, ICI-Mother Baby Childbirth Organization (IMBCO) and International Federation of Gynecology and Obstetrics (FIGO), in which "step 6" recommends: Promote and provide clinical practice based on evidence that has proven to be beneficial and respect the normal physiology of labour. Allowing labour to develop at its own pace, avoiding unnecessary interventions.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age: 37-41 weeks
  • Spontaneous and induced onset of labour
  • Women with low and medium risk during labour and birth with cephalic presentation fetus

排除标准

  • Premature
  • High risk pregnancies and labour
  • Malpositions of the fetus

结局指标

主要结局

Incidence of non-spontaneous vaginal births

时间窗: Immediately after the birth

Investigator will be making this evaluation after birth, evaluating the data obtained from the conventional partogram (in the control group) and from the A-BIRTHPERFORM tool (in the intervention group). The measurements or variables that will be used are: data of the progress of labour entered against time, cervical dilatation, record of start oxytocin use if necessary, time of birth, and birth mode in each group of the trial

次要结局

  • Percentage of compliance with NICE clinical guidelines on artificial rupture of membranes technique(Immediately after the birth)
  • Percentage of compliance with NICE clinical guidelines on oxytocin use during labour(Immediately after the birth)

研究者

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

LAURA GARCIA-LAUSIN

Principal Investigator

Hospital del Mar

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