Chronic Hypertension and Pregnancy (CHAP) Project
Trial ID or NCT#
NCT02299414
Status
RECRUITING
Purpose
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
Official Title
A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project
Eligibility Criteria
Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure <140/90); 2. Singleton; and 3. viable pregnancy <23 weeks of gestation.
Exclusion Criteria:
- 1. Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment); 2. Severe hypertension including patients currently treated with >1 antihypertensive medication (more likely to have severe chronic hypertension); 3. Multi-fetal pregnancy; 4. Known secondary cause of chronic hypertension; 5. High-risk co-morbidities for which treatment may be indicated: - Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years - Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant) - Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, protein/creatinine ratio ≥0.3, or persistent 1+ proteinuria*) or creatinine >1.2. *If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0.3. If a p/c ratio is >0.3, the patient may be included if a 24-hour urine is < 300 mg. - Cardiac disorders: cardiomyopathy, angina, CAD - Prior stroke - Retinopathy - Sickle cell disease 6. Known major fetal anomaly; 7. Known fetal demise; 8. Suspected IUGR; 9. Membrane rupture or planned termination prior to randomization; 10. Plan to deliver outside the consortium centers (unless approved by the Clinical Coordinating Center) or unlikely to follow-up in the opinion of study staff or previous participation in this trial; 11. Contraindication to labetalol and nifedipine (e.g. know hypersensitivity); 12. Current substance abuse or addiction (cocaine, methamphetamine) 13. Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee) 14. Physician or provider refusal 15. Patient refusal *The minimum age varies by center
Investigator(s)
Yasser El-Sayed, Professor
Obstetrician and Gynecologist (OB-GYN)
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
Contact us to find out if this trial is right for you.
Contact
Yasser El-Sayed, MD
650-723-3198
View on ClinicalTrials.gov
