Chronic Hypertension and Pregnancy (CHAP) Project
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Anti-hypertensive therapy; No anti-hypertensive therapy (unless BP is severe)
Intervention description: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol); Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Intervention MeSH terms: Antihypertensive Agents; Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2408.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Pregnancy; Chronic hypertension

Summary:

      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.
    

Eligibility criteria:

        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