Comparing pregnancy outcomes in women with normal blood pressure and stage 1 hypertension
Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study
The Third Affiliated Hospital of Guangzhou Medical University · NCT06339749
This study looks at how having stage 1 hypertension affects pregnancy outcomes compared to women with normal blood pressure to see if different risks for preeclampsia need special attention during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 626 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | The Third Affiliated Hospital of Guangzhou Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06339749 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the impact of stage 1 hypertension on pregnancy outcomes compared to normotensive women. It utilizes first-trimester blood pressure measurements and combines maternal factors, mean arterial pressure (MAP), and placental growth factor (PLGF) to assess the risk of preeclampsia using a Bayesian approach. The study will categorize women into high and low-risk groups for preeclampsia based on their calculated risk and evaluate the necessity of screening for preeclampsia in these populations. Participants will be monitored throughout their pregnancy to compare outcomes based on their blood pressure status.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with a single live fetus and blood pressure below 140/90 mmHg before 14 weeks of gestation.
Not a fit: Patients with underlying conditions such as chronic hypertension, diabetes, kidney disease, or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve prenatal care by identifying women at risk for preeclampsia and potentially reducing complications associated with hypertension during pregnancy.
How similar studies have performed: Other studies have shown success in using similar risk assessment approaches for preeclampsia, indicating that this methodology is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years old; 2. single live fetus with normal NT at 11-14+1 weeks of gestation; 3. Blood pressure \< 140/90 mmHg before 14+1 week of gestation; 4. Plan to have prenatal examination and delivery in our hospital; 5. Sign informed consent. Exclusion Criteria: Underlying diseases (chronic hypertension, type 1 or type 2 diabetes, kidney disease, autoimmune disease).
Where this trial is running
Guangzhou, Guangdong
- FANG HE — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Fang He, M.D — The Third Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Fang He, M.D
- Email: hefangjnu@126.com
- Phone: +86 13724831279
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.
Conditions: stage1 Hypertension, Preeclampsia, stage1 hypertension, observation, pregnancy outcomes