Health Condition 1: O134- Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth Health Condition 2: O133- Gestational [pregnancy-induced] hypertension without significant proteinuria, third trimester Health Condition 3: O140- Mild to moderate pre-eclampsia Health Condition 4: O149- Unspecified pre-eclampsia
Conditions
Interventions
Intervention1: 1. Higher threshold
2. Nifedipine
3. Amlodipine
: Intervention work stream I (Antenatal)
1.Higher threshold of anti hypertensive initiation at more than or equal to 150/100mmHg
2.Me
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Work stream 1 (Managing Antenatal hypertension) Pregnant women with preeclampsia/ gestational Hypertension with singleton pregnancies more than 18 years of Age at gestational Age 30 weeks or more and having blood pressure of Systolic between 140- 150 mmHg and or Diastolic between 90- 100 mmHg Work stream 2 ( timing of delivery) 1.Pregnant women with preeclampsia/ gestational Hypertension with Singleton pregnancies more than 18 years of Age, at gestational age 36 weeks or more Workstream-3 (Managing Postpartum Hypertension) Inclusion criteria: Postpartum women with hypertension more than 18 years of Age, having a blood pressure of Systolic between 140- 150 mmHg and or Diastolic between 90-100mmHg
Exclusion criteria
Exclusion criteria: For Work stream 1,2& 3. a.Referred after receiving antihypertensives more than 24 hours b.Pre-pregnancy hypertensive or blood pressure more than 140/90 at or less than 20 weeks gestational age c.Severe Hypertension (more than 160/110 mmHg) d.HELLP syndrome e.Known Chronic Kidney disease/ heart disease/ Over Diabetes f.Pulmonary oedema g.Severe Thrombocytopenia/ Anaemia For work stream 1 h.Those with severe disease requiring delivery within 24-48 hours or have a diagnosis made at less than 30 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of composite material adverse events defined as one or more of maternal death, pulmonary Edema, renal failure, neurological complications (eclampsia, stroke, PRES), hematological complications (thrombocytopenia, thrombotic microangiopathy, disseminated intravascular coagulation, hemolysis), placental abruption. Incidence of composite neonatal outcomes defined as one or more of stillbirth, neonatal mortality, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, neonatal sepsis 2. Incidence of composite neonatal outcomes defined as one or more of stillbirth, neonatal mortality, hypoxic-ischemic encephalopathy, intraventricular haemorrhage, neonatal sepsisTimepoint: Antenatal, intrapartum , and postpartum till discharge from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Need of additional Anti hypertensive- maintenance after receiving the maximum dose stated in the study 2. Need of additional Antihypertensive- maintenance after receiving the maximum dose stated in the studyTimepoint: till delivery and discharge from the hospital;Long term : Maternal outcomes assessed include hypertension, chronic kidney disease, stroke, and depression. Infantile outcomes include retinopathy of prematurity, hypoxic ischaemic encephalopathy, and bronchopulmonary dysplasiaTimepoint: 18 months postpartum | — |
Countries
India
Contacts
Public ContactDr Anish Keepanasseril
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER, Pondicherry,
Outcome results
None listed