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Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study

Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06339749
Enrollment
626
Registered
2024-04-01
Start date
2024-04-25
Completion date
2026-02-27
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia, stage1 Hypertension

Keywords

stage1 hypertension, Preeclampsia, observation, pregnancy outcomes

Brief 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 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.

Interventions

DIAGNOSTIC_TESTblood pressure

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).

OTHERClinical protocols for preeclampsia risk screening

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.

Sponsors

FANG HE
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
preeclampsiaAfter 20 weeks of gestation until the end of deliveryThe 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.

Secondary

MeasureTime frameDescription
Preterm birthAfter 20 weeks of gestation until the end of deliveryPreterm birth were defined as live birth with gestational age \< 37 weeks.
fetal intrauterine growth restriction (FGR)After 20 weeks of gestation until the end of deliveryFGR 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.
Severe complications of preeclampsiaAfter 20 weeks of gestation until the end of deliveryhemolysis,elevated liver enzymes and low platelets count syndrome

Countries

China

Contacts

Primary ContactFang He, M.D
hefangjnu@126.com+86 13724831279
Backup ContactYafei Wang, Master
542114919@qq.com+86 18716442633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026