stage1 HypertensionNCT06339749
Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study
An observational study of stage1 Hypertension and Preeclampsia, run by FANG HE at 1 site in China.
Trial summary
In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- stage1 Hypertension, Preeclampsia
- What is being tested?
- blood pressure and Clinical protocols for preeclampsia risk screening
- How many people
- 626 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2024to 27 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All the subjects were pregnant women who delivered in our hospital.
Who may be able to join
- Age ≥18 years old;
- single live fetus with normal NT at 11-14+1 weeks of gestation;
- Blood pressure < 140/90 mmHg before 14+1 week of gestation;
- Plan to have prenatal examination and delivery in our hospital;
- Sign informed consent.
Who cannot join
- Underlying diseases (chronic hypertension, type 1 or type 2 diabetes, kidney disease, autoimmune disease).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FANG HE
Guangzhou, Guangdong, 510150
Fang He, M.D, +86 13724831279, hefangjnu@126.com
Yafei Wang, Master, +86 18716442633, 542114919@qq.com
About this study
In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly diagnosed stage 1 hypertension affects pregnancy complications remains unclear. In this study, the combination of maternal factors, MAP and PLGF was used to comprehensively analyze the risk factors of preeclampsia through the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). According to the guidelines and consensus, the pregnant women were considered to be at high risk when the calculated risk was higher than 1% of the population. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia.
Read the detailed description
Based on first-trimester BP measurements, pregnant women were reclassified as normotensive (systolic BP < 120mmHg and diastolic BP <80mmHg on at least two occasions) and stage 1 hypertensive (systolic BP 130-139 mmHg and/or diastolic BP 80-89 mmHg on at least two occasions, without a diagnosis of chronic hypertension and/or elevated BP). At the same time, based on the 2019 FIGO pre-eclampsia screening guidelines, it is recommended that all pregnant women should be screened for pre-eclampsia in the first trimester. In this study, pregnant women who combined maternal factors, MAP and PLGF were analyzed by the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). Its online computing website: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester. The individual risk of preterm PE was calculated at 11-14+1 weeks of gestation using the British Fetal Medicine Foundation (FMF) algorithm. Previous risk was calculated based on maternal demographic characteristics and obstetric history. Therefore, 1/100 was selected as the cut-off value, ≥1/100 was registered as high risk of preeclampsia, < 1/100 was registered as low risk of preeclampsia. For people with high risk of preeclampsia (≥1/100) evaluated in the first trimester, low-dose aspirin prevention for preeclampsia is recommended between 12 and 28 weeks of gestation (preferably before 16 weeks). And continued until 36 weeks. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia.
- Conditions
- stage1 Hypertension, Preeclampsia
- Being tested
- blood pressure, Clinical protocols for preeclampsia risk screening
- Keywords
- stage1 hypertension, Preeclampsia, observation, pregnancy outcomes
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressureDiagnostic test
Based on first-trimester BP measurements, pregnant women were reclassified as normotensive (systolic BP < 120mmHg and diastolic BP <80mmHg on at least two occasions) and stage 1 hypertensive (systolic BP 130-139 mmHg and/or diastolic BP 80-89 mmHg on at least two occasions, without a diagnosis of chronic hypertension and/or elevated BP).
Clinical protocols for preeclampsia risk screeningOther
In this study, the risk factors of preeclampsia in pregnant women with combined maternal factors, MAP and PLGF were comprehensively analyzed by the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). The online calculation website is: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester.
| Study group | Role | What they receive |
|---|---|---|
| Main study objective Groups: normotensive group | Main study objective Groups: normotensive group Receives: Diagnostic Test: blood pressure | |
| Main study objective Groups: Stage 1 hypertension group | Main study objective Groups: Stage 1 hypertension group Receives: Diagnostic Test: blood pressure | |
| Secondary objective grouping: Stage 1 hypertension low-risk group | Secondary objective grouping: Stage 1 hypertension low-risk group Receives: Diagnostic Test: blood pressure; Other: Clinical protocols for preeclampsia risk screening | |
| Secondary objective grouping: Stage 1 hypertension high-risk group | Secondary objective grouping: Stage 1 hypertension high-risk group Receives: Diagnostic Test: blood pressure; Other: Clinical protocols for preeclampsia risk screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
preeclampsia
The criteria for preeclampsia were based on the Chinese Guidelines for the Diagnosis and Treatment of Hypertensive Disorders in Pregnancy, which were systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg after 20 weeks of gestation, accompanied by any one of the following: Urine protein ≥0.3 g/24h, or urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+). There is no proteinuria, but there is involvement of any of the following organs or systems: important organs such as the heart, lungs, liver, kidney, or abnormal changes in the blood system, digestive system, nervous system, placental-fetal involvement.
Measured: After 20 weeks of gestation until the end of delivery
Secondary outcomes (3)
Preterm birth
Preterm birth were defined as live birth with gestational age < 37 weeks.
Measured: After 20 weeks of gestation until the end of delivery
fetal intrauterine growth restriction (FGR)
FGR is a condition in which fetal growth does not reach its genetic potential due to the influence of maternal, fetal, placental and other pathological factors, mostly manifested as fetal ultrasonographic estimated weight or abdominal circumference below the 10th percentile for gestational age.
Measured: After 20 weeks of gestation until the end of delivery
Severe complications of preeclampsia
hemolysis，elevated liver enzymes and low platelets count syndrome
Measured: After 20 weeks of gestation until the end of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start25 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for stage1 HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FANG HE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FANG HE, The Third Affiliated Hospital of Guangzhou Medical University
- Investigators
- Fang He, M.D, Principal investigator, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339749
- Sponsor's protocol ID
- [2024] Ethics Review NO.040
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06339749
- Acronym / sponsor ID
- [2024] Ethics Review NO.040
- Conditions
- stage1 Hypertension, Preeclampsia
- Keywords
- stage1 hypertension, Preeclampsia, observation, pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 626 participants (estimated)
- Lead sponsor
- FANG HEUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly diagnosed stage 1 hypertension affects pregnancy complications remains unclear. In this study, the combination of maternal factors, MAP and PLGF was used to comprehensively analyze the risk factors of preeclampsia through the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). According to the guidelines and consensus, the pregnant women were considered to be at high risk when the calculated risk was higher than 1% of the population. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia.
Detailed description
Based on first-trimester BP measurements, pregnant women were reclassified as normotensive (systolic BP < 120mmHg and diastolic BP <80mmHg on at least two occasions) and stage 1 hypertensive (systolic BP 130-139 mmHg and/or diastolic BP 80-89 mmHg on at least two occasions, without a diagnosis of chronic hypertension and/or elevated BP). At the same time, based on the 2019 FIGO pre-eclampsia screening guidelines, it is recommended that all pregnant women should be screened for pre-eclampsia in the first trimester. In this study, pregnant women who combined maternal factors, MAP and PLGF were analyzed by the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). Its online computing website: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester. The individual risk of preterm PE was calculated at 11-14+1 weeks of gestation using the British Fetal Medicine Foundation (FMF) algorithm. Previous risk was calculated based on maternal demographic characteristics and obstetric history. Therefore, 1/100 was selected as the cut-off value, ≥1/100 was registered as high risk of preeclampsia, < 1/100 was registered as low risk of preeclampsia. For people with high risk of preeclampsia (≥1/100) evaluated in the first trimester, low-dose aspirin prevention for preeclampsia is recommended between 12 and 28 weeks of gestation (preferably before 16 weeks). And continued until 36 weeks. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Main study objective Groups: normotensive group | – | Diagnostic Test: blood pressureMain study objective Groups: normotensive group |
| Main study objective Groups: Stage 1 hypertension group | – | Diagnostic Test: blood pressureMain study objective Groups: Stage 1 hypertension group |
| Secondary objective grouping: Stage 1 hypertension low-risk group | – | Diagnostic Test: blood pressure, Other: Clinical protocols for preeclampsia risk screeningSecondary objective grouping: Stage 1 hypertension low-risk group |
| Secondary objective grouping: Stage 1 hypertension high-risk group | – | Diagnostic Test: blood pressure, Other: Clinical protocols for preeclampsia risk screeningSecondary objective grouping: Stage 1 hypertension high-risk group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All the subjects were pregnant women who delivered in our hospital.
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- single live fetus with normal NT at 11-14+1 weeks of gestation;
- Blood pressure < 140/90 mmHg before 14+1 week of gestation;
- Plan to have prenatal examination and delivery in our hospital;
- Sign informed consent.
Key exclusion criteria (1 listed)
- Underlying diseases (chronic hypertension, type 1 or type 2 diabetes, kidney disease, autoimmune disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressureBased on first-trimester BP measurements, pregnant women were reclassified as normotensive (systolic BP < 120mmHg and diastolic BP <80mmHg on at least two occasions) and stage 1 hypertensive (systolic BP 130-139 mmHg and/or diastolic BP 80-89 mmHg on at least two occasions, without a diagnosis of chronic hypertension and/or elevated BP). | Diagnostic test | Main study objective Groups: Stage 1 hypertension group, Main study objective Groups: normotensive group, Secondary objective grouping: Stage 1 hypertension high-risk group, Secondary objective grouping: Stage 1 hypertension low-risk group |
| Clinical protocols for preeclampsia risk screeningIn this study, the risk factors of preeclampsia in pregnant women with combined maternal factors, MAP and PLGF were comprehensively analyzed by the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). The online calculation website is: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester. | Other | Secondary objective grouping: Stage 1 hypertension high-risk group, Secondary objective grouping: Stage 1 hypertension low-risk group |
Primary outcome
preeclampsia
Time frame: After 20 weeks of gestation until the end of delivery
The criteria for preeclampsia were based on the Chinese Guidelines for the Diagnosis and Treatment of Hypertensive Disorders in Pregnancy, which were systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg after 20 weeks of gestation, accompanied by any one of the following: Urine protein ≥0.3 g/24h, or urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+). There is no proteinuria, but there is involvement of any of the following organs or systems: important organs such as the heart, lungs, liver, kidney, or abnormal changes in the blood system, digestive system, nervous system, placental-fetal involvement.
3 secondary outcomes
Preterm birth
Time frame: After 20 weeks of gestation until the end of delivery
fetal intrauterine growth restriction (FGR)
Time frame: After 20 weeks of gestation until the end of delivery
Severe complications of preeclampsia
Time frame: After 20 weeks of gestation until the end of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang He, M.D principal investigator
The Third Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of stage1 Hypertension and Preeclampsia, run by FANG HE at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang He, M.D (+86 13724831279, hefangjnu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preeclampsia (time frame: After 20 weeks of gestation until the end of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.