DevelopmeNt, implementation and evaluation of Protocolized cArdio-obstetric Care in improving maternal cardiac, obstetric and fetal outcomes of Pregnant Women with Heart Diseases in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,300
- 试验地点
- 56
- 主要终点
- Composite Maternal adverse events as mentioned below
研究概览
简要总结
**Background:**Heart disease complicates 1- 4% of pregnancies. The number of women presenting with heart disease during pregnancy is increasing. Despite the reduction in maternal mortality in India over the past two decades, cardiac contribution to maternal mortality is increasing. Data on pregnant women with heart disease (PWWHD) representative of our nation, local risk scores and guidelines /protocols are lacking.
Novelty: A pragmatic protocol for managing PWWHD will be developed and tested. Data representative of India will be collected. Findings may influence care and pregnancy outcomes in other low and middle-income countries.
Aims and Objectives: To study profile and feto-maternal outcomes of PWWHD in India, to understand the existing practice patterns in care offered to PWWHD in India, develop a customized protocol for managing PWWHD appropriate for India, and assess its impact on outcomes compared to usual care
To develop a regional score for risk stratifying PWWHD in India to enable targeted management.
Methods: We propose a multicentric study covering 24 states in India. During Phase 1 of the study, the practice patterns in managing PWWHD will be assessed across 50 centres in India and a step-wise protocol to improve outcome will be developed. During phase 2, a cluster randomized study will be conducted among 40 average-large centres across India to assess the effectiveness of the protocolized cardio-obstetric care in improving outcomes compared to usual care.
Expected outcome: A protocol for managing PWWHD in India will be developed. A regional score for risk-stratifying PWWHD in India will be developed and validated. The contribution of heart disease to maternal mortality in India will be reduced in the years that follow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •All consecutive pregnant women with known or newly detected heart diseases mentioned below, seeking antenatal care in the participating sites will be eligible for inclusion.
- •Structural Heart disease- congenital or acquired Arrhythmic heart disease Ischemic heart disease Aortic diseases Pulmonary vascular disease.
排除标准
- •Patients with hypertensive disorders of pregnancy or gestational diabetes mellitus without any of the above inclusion criteria Patients below the age of 18 Patients who are not able to or not willing to give informed consent.
- •Patients who are part of another trial.
结局指标
主要结局
Composite Maternal adverse events as mentioned below
时间窗: 42 days after delivery
Maternal death
时间窗: 42 days after delivery
Resuscitated cardiac arrest
时间窗: 42 days after delivery
New or worsening maternal heart failure requiring treatment escalation or hospitalization (Left-sided heart failure (HF) or pulmonary edema; right-sided HF)
时间窗: 42 days after delivery
New onset or recurrent sustained cardiac arrhythmia requiring treatment
时间窗: 42 days after delivery
Systemic thrombo-embolism
时间窗: 42 days after delivery
Hemorrhagic complications (Major bleed or minor bleed as per ISTH Criteria)
时间窗: 42 days after delivery
Venous thrombo-embolism (DVT / PE / Invictus trial)
时间窗: 42 days after delivery
Cerebrovascular accident / Stroke
时间窗: 42 days after delivery
Infective endocarditis
时间窗: 42 days after delivery
Prosthetic valve thrombosis
时间窗: 42 days after delivery
Aortic dissection developing during pregnancy
时间窗: 42 days after delivery
Acute coronary syndrome / SCAD
时间窗: 42 days after delivery
Performance of urgent cardiac intervention up to 6th postpartum week
时间窗: 42 days after delivery
( like PTMC, Pericardiocentesis, RF ablation)
时间窗: 42 days after delivery
次要结局
- Maternal Death(6 months)
- Decline in NYHA functional class ≥ 2 during pregnancy(42 days after delivery)
- Cardiac hospitalization
- PPH
- Gestational diabetes
- Mode of delivery (If LSCS – emergency LSCS / elective LSCS, Cardiac indication / obstetric indication)
- Hypertensive disorders of pregnancy
- PROM- Premature rupture of membranes
- Urgent unplanned cardiac hospitalization(Antenatal period and upto 6 weeks in the post natal period)
- Miscarriage (fetal loss up to 20 weeks)
- Fetal loss after 20th week.
- Small for gestational age(During Delivery)
- Low birth weight (less than 2.5 kg irrespective of gestational age)
- Preterm birth
- Admission to neonatal intensive care unit
- Neonatal death
- Congenital anomalies (including CHD) in the new born
- Elective cardiac interventions done (Lysis, ablation, Balloon, surgery)(Antenatal period and upto 6 weeks in the post natal period)
- Duration of stay in ICU
研究者
Dr G Justin Paul
Madras Medical College