Placental Growth factor testing for reduction of Adverse Outcomes (PAPAGAIO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 5
- 主要终点
- PAPAGAIO–Delivery:
研究概览
简要总结
PAPAGAIO: Preterm pre-eclampsiA: PlAcental Growth factor (PIGF) testing for reduction of Adverse Outcomes
Background: It is estimated that preeclampsia causes 30,000 maternal and 500,000 perinatal deaths annually, most of which occur in low- and middle-income countries. Many of these deaths could be preventable with early diagnosis and appropriately timed delivery. Preeclampsia diagnosis can be challenging in high-burden, low-resource settings. Placental growth factor (PlGF) is abnormally low in pre-eclampsia. PlGF outperforms all other preeclampsia diagnostics, reducing time to diagnosis and adverse maternal outcomes in a high-income setting. It has not yet been definitively evaluated in low resource settings, where the greatest health burden lies.
Objectives:
1) Describe care pathways for preterm pre-eclampsia, identify barriers to, and facilitators of
PlGF testing in LMICs
2) Assess clinical and cost effectiveness of PlGF testing in suspected preterm pre-eclampsia
3) Evaluate clinical and cost effectiveness of planned early delivery in late preterm preeclampsia with diagnosis incorporating PlGF testing
4) Validate new point of care PlGF test devices
5) Establish a biobank of samples from women with suspected and confirmed preeclampsia.
6) Sustainably build local research capacity at individual and institutional levels.
Methods: There are five main workstreams that will be conducted semi-concurrently.
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Prepare for PAPAGAIO: a six-month mixed-methods observational feasibility study to describe current preeclampsia care, optimise PlGF testing and conduct community engagement.
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PAPAGAIO-Diagnosis: a randomised controlled trial comparing revealed PlGF to usual care, in women with suspected pre-eclampsia.
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PAPAGAIO-Delivery: a randomised controlled trial comparing planned delivery with usual care of expectant management, in women with late preterm pre-eclampsia (diagnosis incorporating PlGF testing)
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PAPAGAIO New Test Validation Study: a validation study of new point of care PlGF testing devices on 1500 samples. The results will be concealed from participants and clinicians and not used to inform clinical care.
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PAPAGAIO Biobank: Establish a biobank of blood and urine samples from 1500 women suspected and confirmed preeclampsia for the use in future ethically approved research studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •PAPAGAIO Delivery • Preeclampsia confirmed with abnormal PlGF result • Between 34 and 36 plus 6 weeks gestation • Singleton pregnancy • Live pregnancy • Able to give informed consent PAPAGAIO Diagnosis • Hypertension or other clinical suspicion of preeclampsia • Between 20 and 36 plus 6 weeks gestation • Singleton pregnancy • Live pregnancy • Able to give informed consent Prepare for PAPAGAIO QUALITATIVE STUDY Women will be eligible for recruitment to an interview or focus group if they are • Over 18 years of age • Able to give valid consent • Currently pregnant with a viable, ongoing pregnancy, or have had previous lived experience of preeclampsia • Attending or previously attended one of the designated trial sites for antenatal care Partners and family members will be eligible for recruitment to an interview focus group if they are • Over 18 years of age • Able to give valid consent • The partner, or close family member, of a woman participating in a focus group who has given her permission for her partner or family member to be invited.
- •Stakeholders will be eligible for recruitment to an interview or focus group if they are • Over 18 years of age • Able to give valid consent • Identified as being a key stakeholder in the stakeholder analysis.
排除标准
- •PAPAGAIO Delivery • In active labour • Indication for immediate delivery • Decision to deliver within 48 hours already made • Clinician diagnosis of preeclampsia and a normal PlGF result these women will not be randomised but will be followed up in an observational cohort PAPAGAIO Diagnosis • In active labour • Decision to deliver within 24 hours already made.
结局指标
主要结局
PAPAGAIO–Delivery:
时间窗: Up to 7 days postpartum
Maternal: A composite of severe maternal adverse outcomes relating to pre-eclampsia: maternal mortality; eclampsia; stroke; cortical blindness; retinal detachment; pulmonary oedema/severe breathing difficulty; severe acute kidney injury (creatinine more than 150 micro mol per Litre); liver capsule haematoma or rupture; placental abruption; post-partum haemorrhage; hepatic dysfunction; platelets more than 50 times 10 to the power of 9 platelets per Litre; ICU admission; intubation and ventilation (other than for delivery); termination pre-viability for maternal preeclampsia.
时间窗: Up to 7 days postpartum
PAPAGAIO - Diagnosis:
时间窗: Up to 7 days postpartum
Composite maternal and perinatal outcome of:
时间窗: Up to 7 days postpartum
• Maternal mortality; eclampsia; placental abruption; termination pre-viability for maternal preeclampsia; stillbirth or early neonatal death
时间窗: Up to 7 days postpartum
次要结局
- PAPAGAIO–Delivery:(Tested Maternal Outcomes: Severe hypertension more than or equal to 160mmHg, Time to delivery, Time to initiation of delivery, Mode of birth (vaginal, assisted vaginal, caesarean section), Eclampsia, Placental abruption, Postpartum haemorrhage requiring transfusion or hysterectomy, Length of stay)
- PAPAGAIO–Delivery:(Tested Perinatal Outcomes; Stillbirth, Early neonatal death (within 7 days of life), Neonatal unit admission, Gestational age at delivery, Preterm birth before 37 weeks gestation, Preterm birth before 34 weeks gestation, Birthweight less than 10th centile (Intergrowth-21))
- PAPAGAIO–Delivery:(Perinatal Outcomes; Neonatal death (7 – 28 days of life), Respiratory support, Sepsis, Neonatal seizures, Birthweight, Birthweight less than 3rd centile (Intergrowth-21), Length, Antibiotics given, APGARs at 1 and 5 minutes, Need for neonatal resuscitation, Hypoxic Ischaemic Encephalopathy and grade, Respiratory distress syndrome, Supplementary oxygen and duration, Administration of surfactant, Hypoglycaemias requiring intervention, Hypothermia Temp less than 35.6, Neonatal jaundice requiring phototherapy, Necrotising enterocolitis, Nasogastric feeding required, Umbilical pHs, Abnormal cerebral ultrasound)
- PAPAGAIO–Delivery:(Health resource use outcomes for budget impact analysis; number of POC-PlGF cartridges used, wastage of consumables e.g. due to protracted time un-refrigerated)
- PAPAGAIO–Delivery:(Maternal; Antenatal outpatient attendances, Inpatient days, Intensive care unit use)
- PAPAGAIO–Delivery:(Perinatal; Total days in hospital, Total days in each level of care (intensive care, high dependency and special care unit days))
研究者
Dr Shivaprasad S Goudar
J N Medical College, KLE Academy of Higher Education and Research Belagavi