Phase 4
N=2,408
Chronic Hypertension and Pregnancy (CHAP) Project
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02299414 ↗Enrolled (actual)
2,408
Serious AEs
9.9%
Results posted
May 2023
Primary outcome: Primary: Composite Adverse Perinatal Outcome — 353; 427; 272; 336 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Anti-hypertensive therapy (Drug); No anti-hypertensive therapy (unless BP is severe) (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Adverse Perinatal Outcome |
353; 427; 272; 336; 143; 193 | <0.001 sig |
| PRIMARY Small for Gestational Age (Safety) |
128; 117 | 0.56 |
| SECONDARY Composite of Maternal Death or Severe Cardiovascular Morbidity |
25; 33 | — |
| SECONDARY Severe Maternal Hypertension + Components of the Primary Composite Endpoint |
529; 631 | — |
| SECONDARY Preterm Birth and Indicated Preterm Birth (<37 Weeks) |
332; 377 | — |
| SECONDARY Composite of Severe Neonatal Morbidities |
24; 31 | — |
| SECONDARY Adherence to Treatment After Delivery |
436; 275 | — |
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
- 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 1 antihypertensive medication (more likely to have severe chronic hypertension);
- Multi-fetal pregnancy;
- Known secondary cause of chronic hypertension;
- 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 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
- Known major fetal anomaly;
- Known fetal demise;
- Suspected IUGR;
- Membrane rupture or planned termination prior to randomization;
- 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;
- Contraindication to labetalol and nifedipine (e.g. know hypersensitivity);
- Current substance abuse or addiction (cocaine, methamphetamine)
- Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee)
- Physician or provider refusal
- Patient refusal *The minimum age varies by center
Data sourced from ClinicalTrials.gov (NCT02299414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.