Pilot project on treating hypertension during pregnancy
Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial
This study is testing if treating high blood pressure earlier in pregnant women can help improve their baby's birth weight compared to usual care.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 14 Years to 89 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05989581 on ClinicalTrials.gov |
What this trial studies
The CHAP2 pilot project aims to gather preliminary data for a larger multicenter study focused on the treatment of stage 1 hypertension in pregnant women. This study will randomize participants to either a treatment group aiming for blood pressure below 130/80 mmHg or a usual care group, where treatment is only initiated if blood pressure reaches 140/90 mmHg. The primary goal is to assess whether achieving lower blood pressure targets can positively influence birthweight percentiles at delivery. A total of 74 eligible participants will be enrolled in this pilot study at UAB Hospital.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with stage 1 hypertension planning to deliver at UAB Hospital.
Not a fit: Patients with chronic hypertension or those requiring more stringent blood pressure control will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal and neonatal outcomes for pregnant women with stage 1 hypertension.
How similar studies have performed: While this pilot project is novel in its specific approach, similar studies have shown promise in managing hypertension during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Viable singleton gestation * No fetal anomalies * Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation * Planning to deliver at UAB Hospital * No indication for pregnancy termination * Receiving care at the UAB prenatal clinics Exclusion Criteria: * Declines Randomization * Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use * Fetal demise diagnosed prior to enrollment * Known major structural of chromosomal abnormalities prior to enrollment * Contraindication to first line antihypertensive (Nifedipine/ Labetalol) * Comorbidities requiring BP goals \< 130/80mmHg
Where this trial is running
Birmingham, Alabama
- UAB — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Donna Dunn, PhD
- Email: dcampbell@uabmc.edu
- Phone: 12058739503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.