ASSIST Ethiopia: Feasibility Clinical Investigation of Assisted Vaginal Birth With the Odonassist™ Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of delivery assistance with the OdonAssistTM medical device
研究概览
简要总结
The Innovation The OdonAssist™ is a medical device for assisted vaginal delivery (AVD), that is defined by the need of additional procedure to facilitate childbirth in order to reduce foetal-maternal risks. Increasing access to AVD has been identified by the World Health Organization (WHO) as one of the priorities for improving maternal health globally. The OdonAssist™ is a frugal innovation born in the southern hemisphere in an unconventional environment. It was invented by an Argentinian mechanic, Jorge Odon. Its potential to improve maternal and neonatal health is now recognised. It has been designed to be safe, simple to use and better accepted than current devices (forceps, suction cup). Two studies conducted in England and one in France have confirmed these characteristics and funding has recently been obtained for a randomised clinical investigation in five French hospitals.
Project Rationale The present project aims to conduct a feasibility study at Saint Luke's Hospital in Wolisso, a poorly resourced hospital in rural Ethiopia, in order to test the device in a low-income country and assess its acceptability. In addition, with the aim of investigating the efficiency and budgetary impact of this new device, and considering the wider perspective of a future scale-up, data will be collected on its cost-effectiveness, in order to compare it with the reference interventions at local level (vacuum and caesarean section).
Main research questions:
- Is it feasible to introduce the OdonAssist™ (new intervention) at the hospital Saint Luke's in Ethiopia, in terms of preliminary data on safety, efficacy, acceptability by mothers and healthcare providers?
- What are the estimated healthcare-related costs of the OdonAssist™ (new intervention) in comparison to traditional alternatives, that are vacuum-assisted delivery or cesarean section during the second stage of labor?
Study population Participants will be assisted with the OdonAssist™ medical device in case they have provided informed consent and they present medical indication for AVD as per protocol. The study will also collect data on a nested cohort of women and babies delivered either by vacuum extractor or by second-stage cesarean section. The information gained from this study will be used to plan for future impact evaluation and cost utility studies relevant for the implementation and for the scaling up of the OdonAssist™ in low resource settings.
The study site will be Saint Luke's Hospital, Wolisso, Oromia region, Ethiopia.
详细描述
INTRODUCTION
The OdonAssist™ inflatable device for assisted vaginal birth (AVB), is a frugal innovation from the southern hemisphere and an unconventional environment as it was invented by an Argentinian car mechanic, Jorge Odon. The device has been developed with the intention to be safe, easy to use and more acceptable than currently used AVB devices (forceps and vacuum extractor) because of its innovative mechanism of action. Its potential for improving maternal and neonatal health is now recognized based on the results of three clinical trials conducted in France and UK.
The investigation proposal is to conduct a feasibility study of OdonAssistTM at Saint Luke's Hospital in Wolisso, Ethiopia, to determine the feasibility of using the OdonAssistTM in a low-income country and assess its acceptability in those settings. In addition, with a view to researching the efficiency and budgetary impact of this innovation, data will be collected on its cost and effectiveness, for comparison with reference interventions at local level (vacuum extractor and emergency second stage caesarean section).
Improving the health of mothers and newborns is among the main priorities of the Ethiopian Health Sector Strategic Plan (HSDP IV). The 2016 Ethiopian Demographic and Health Survey preliminary report indicated that Ethiopia has made good progress in reducing neonatal, infant and under five mortalities reporting respectively 29, 48 and 67 deaths per 1,000 live births in years 0-4 prior to the survey, while these figures were 47, 78 and 116 deaths per 1,000 live births 10-14 years prior to the survey. However, the neonatal mortality rate has not declined significantly, nor has the infant and under-five mortality rate and the maternal mortality rate, which is still high at 557 maternal deaths per 100,000 live births caused by pregnancy-related complications (https://data.worldbank.org/indicator/SH.STA.MMRT.NE).
Complications in childbirth are a major cause of maternal and infant mortality and morbidity, accounting for 4-13% of maternal deaths and 25% of neonatal deaths worldwide. Approximately 10-15% of the 134,000,000 births worldwide each year require assistance with forceps or vacuum extractor or emergency caesarean section at full cervical dilation to avoid serious maternal and neonatal complications. In Ethiopia, it is estimated that 12% of pregnant women have a complicated labor, which, according to published studies, causes between 17% and 36% of maternal deaths, 24% of neonatal deaths, 36% of stillbirths and high rates of obstetric fistulas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Women will be able to participate in the ASSIST Ethiopia Study if all of the following apply at initial consent:
- •≥18 years of age;
- •singleton pregnancy of at least 36 weeks' gestation,
- •negative antenatal screen for HIV and Hepatitis B,
- •in active labour and requiring an assisted vaginal birth for a clinical indication (as per local guidelines),
- •the vertex is 1 cm or more below the ischial spines and there is no obstetric indication for an alternative method of AVB.
排除标准
- •Women will not be able to take part in the ASSIST Ethiopia Study if:
- •the fetal vertex is at or above the ischial spines,
- •there is a diagnosis of a fetal skull abnormality (i.e. macrocephaly) or osteogenesis imperfecta,
- •there is a suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia),
- •there is an intrauterine fetal death in the current pregnancy,
- •the woman is sensitive to latex,
- •the woman is currently serving a prison sentence,
- •there is a fetal bradycardia which is on-going and has not recovered.
研究组 & 干预措施
OdonAssistTM medical device
The ASSIST Ethiopia Study is a feasibility study of women who require an assisted vaginal birth (AVB) for a recognized clinical indication. Assistance will be performed using the OdonAssistTM medical device.
干预措施: OdonAssistTM (Device)
结局指标
主要结局
Efficacy of delivery assistance with the OdonAssistTM medical device
时间窗: From enrollment to 6 weeks postpartum
Rate of births successfully assisted with the OdonAssist. An assisted vaginal birth will be defined as 'successful' if all of the following criteria are met: * The birth of the baby is expedited with the OdonAssist. (without sequential use of other AVB devices or resorting to cesarean section). * There are no serious maternal adverse reactions related to the use of the device during birth. * There are no serious neonatal adverse reactions related to the use of the device during birth
次要结局
- Maternal safety - cesarean section performed(From enrollment to 6 weeks postpartum)
- Neonatal safety - Apgar scores at 1, 5 and 10 minutes after birth.(From enrollment to 6 weeks postpartum)
- Neonatal safety - Shoulder dystocia(From enrollment to 6 weeks postpartum)
- Neonatal safety - other neonatal complication(From enrollment to 6 weeks postpartum)
- Birth related outcomes - Time from 'device application" to 'birth' (minutes).(From enrollment to 6 weeks postpartum)
- Acceptability of the OdonAssistTM medical device - Woman acceptability will be assessed through the patient perception score of birth experience on days 1 postnatal and through qualitative assessment(From enrollment to 6 weeks postpartum)
- Health economics - Health care resource use and associated health care costs (USD)(From enrollment to 6 weeks postpartum)
- Maternal safety - Perineal and anal sphincter injury(From enrollment to 6 weeks postpartum)
- Maternal safety - Ischio-rectal fossa defect(From enrollment to 6 weeks postpartum)
- Neonatal safety - Admission to Neonatal Intensive Care Unit (NICU).(From enrollment to 6 weeks postpartum)
- Neonatal safety - Duration of admission in NICU (hours).(From enrollment to 6 weeks postpartum)
- Neonatal safety - Neonatal death(From enrollment to 6 weeks postpartum)
- Neonatal safety - Neonatal Infant Pain Scores at 2 and 6 h post birth.(From enrollment to 6 weeks postpartum)
- Device-related outcomes - Number of pulls of the device.(From enrollment to 6 weeks postpartum)
- Maternal safety - Weighed blood loss (grams)(From enrollment to 6 weeks postpartum)
- Maternal safety - Cervical tear(From enrollment to 6 weeks postpartum)
- Birth related outcomes - Location of birth.(From enrollment to 6 weeks postpartum)
- Device-related outcomes - Failure of a component of the OdonAssist.(From enrollment to 6 weeks postpartum)
- Patient-reported outcomes - Maternal health-related quality of life data (EQ-5D-5L) at day 1 postnatal.(From enrollment to 6 weeks postpartum)
- Maternal safety - Maternal death(From enrollment to 6 weeks postpartum)
- Neonatal safety - Neonatal soft tissue trauma(From enrollment to 6 weeks postpartum)
- Birth related outcomes - Time from 'decision to perform assisted birth' to 'birth' (minutes).(From enrollment to 6 weeks postpartum)
- Birth related outcomes - Mode of birth following failed use of OdonAssist.(From enrollment to 6 weeks postpartum)
- Device-related outcomes - Number of applications of device.(From enrollment to 6 weeks postpartum)
- Device-related outcomes - Perceived reason for device failure from operator(From enrollment to 6 weeks postpartum)
- Patient-reported outcomes - Maternal perception of pain at day 1 postnatal(From enrollment to 6 weeks postpartum)
- Acceptability of the OdonAssistTM medical device - Practitioner acceptability will be assessed through perceived outcomes following each attempted AVB.(From enrollment to 6 weeks postpartum)