Health Condition 1: O994- Diseases of the circulatory systemcomplicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Protocolised Cardio Obstetric Care: A protocol for managing heart disease in pregnant women will be developed in the first observational phase. The sites randomized to Protocolised Card
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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 For the trial phase, enrollemnt is not allowed after 34 weeks gestational age, Patients with mild diseases are excluded
Exclusion criteria
Exclusion criteria: 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 For the CRT phase enrollment after 34 weeks gestational age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Maternal adverse events as mentioned below Maternal death Resuscitated cardiac arrest New or worsening maternal heart failure requiring treatment escalation or hospitalization (Left-sided heart failure (HF) or pulmonary edema; right-sided HF) New onset or recurrent sustained cardiac arrhythmia requiring treatment Systemic thrombo-embolism Hemorrhagic complications (Major bleed or minor bleed as per ISTH Criteria) Venous thrombo-embolism (DVT / PE / Invictus trial) Cerebrovascular accident / Stroke Infective endocarditis Prosthetic valve thrombosis Aortic dissection developing during pregnancy Acute coronary syndrome / SCAD Performance of urgent cardiac intervention up to 6th postpartum week ( like PTMC, Pericardiocentesis, RF ablation) Timepoint: 42 days after delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of stay in ICU Timepoint: Antenatal period and upto 6 weeks in the post natal period;All cause Maternal DeathTimepoint: 6 months;worsening of NYHA functional by one or more class during pregnancyTimepoint: 42 days after delivery;Cardiac hospitalization Timepoint: Antenatal period and upto 6 weeks in the post natal period;PPH Timepoint: Peripartum Period;Gestational diabetes Timepoint: Antenatal Period;Mode of delivery (If LSCS â?? emergency LSCS / elective LSCS, Cardiac indication / obstetric indication) Timepoint: Peripartum Period;Hypertensive disorders of pregnancy Timepoint: Antenatal Period;PROM- Premature rupture of membranes Timepoint: During delivery;Urgent unplanned cardiac hospitalizationTimepoint: Antenatal period and upto 6 weeks in the post natal period;Miscarriage (fetal loss up to 20 weeks) Timepoint: First 20 weeks in the antenatal period;Fetal loss after 20th week. Timepoint: First 20 weeks in the antenatal period;Small for gestational ageTimepoint: During Delivery;Low birth weight (less than 2.5 kg irrespective of gestational age) Timepoint: During delivery;Preterm birth Timepoint: During Delivery;Admission to neonatal intensive care unit Timepoint: 6 weeks in the post natal period;Neonatal death Timepoint: 6 weeks in the post natal period;Congenital anomalies (including CHD) in the new born Timepoint: 6 weeks in the post natal period;Elective cardiac interventions done (Lysis, ablation, Balloon, surgery)Timepoint: Antenatal period and upto 6 weeks in the post natal period | — |
Countries
India
Contacts
Public ContactDr G Justin Paul
Madras Medical College
Outcome results
None listed