pregnancy complicates chronic hypertension
Conditions
Interventions
High target blood pressure group:Do not give anti-hypertensive until blood pressure reach or above 156/106 mmHg.
Low target blood pressure group:Give anti-hypertensive as soon as randomized. Keep the blood pressure from 120 to 139 mmHg systolic, and from 70 to 89 mmHg diastolic.
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. viable pregnancy =17+6 weeks of gestation; 2. Aged from 18-50 years; 3. Singleton; 4. For women with no hypertensive history, blood pressure 140-154mmHg systolic or 90-105mmHg diastolic on two occasions in the clinic at least 4 hours apart; 5. For women with known chronic hypertension, blood pressure 140-154mmHg systolic or 90-105mmHg diastolic on two occasions in the clinic at least 5 minutes apart, no matter she is taking any antihypertensives or not; 6. For women who is doubtful for her diagnosis of hypertension, 24 hours ambulatory blood pressure monitoring should be provided, with average blood pressure 130/80mmHg or more being the criteria for hypertension.
Exclusion criteria
Exclusion criteria: 1. For women has chronic hypertension, blood pressures prior to randomization =156mmHg systolic or =106mmHg diastolic on two occasions in the clinic at least 5 minutes apart no matter she is receiving antihypertensives or not; 2. For women with no hypertensive history, if the first blood pressure is =156mmHg systolic or =106mmHg diastolic, she can rest for at least 4 hours, and the second blood pressure is still =156mmHg systolic or =106mmHg diastolic; 3. Patients currently treated with >1 antihypertensive medication; 4. multiple pregnancy; 5. Baseline proteinuria =50mg/dl in routine urine test; 6. Bastline proteinuria =300mg/24-hours; 7.Blood creatinine=80µmol/L; 8. Left ventricular hypertrophy found by electrocardiogram or echocardiography prior to randomization; 9. Overt diabetes mellitus prior to randomization; 10. Clinical hyperthyroidism or hypothyroidism; 11. Elevated ALT, AST or severe hypoproteinemia, do not return to normal in 2 weeks; 12. Platelet less than 100×10^9/L; 13.Hemoglobin less than 90g/L; 14. Known secondary cause of chronic hypertension; 15. Cerebrovascular disease; 16. History of myocardial infarction or heart failure; 17. Retinopathy; 18. Have other severe diseases; 19. Had attended other intervention clinical trials in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One of more severe outcomes including maternal death; fetal or neonatal death up to 7 days; cardiovascular accident; stroke; preeclampsia with severe features; or indicated PTB =34+6 weeks.;Fetal growth restriction;Small for gestational age; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe hypertension;postpartum hemorrhage;cesarean delivery;maternal hypotension;neonatal asphyxia;NICU admission; | — |
Countries
China
Contacts
Public ContactDI Wen
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed