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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06339749
• Other study ID #: [2024] Ethics Review NO.040
• Status: Not yet recruiting
• Start date: April 25, 2024
• Est. completion date: February 27, 2026

Study information

• Verified date: March 2024
• Source: The Third Affiliated Hospital of Guangzhou Medical University
• Contact: Fang He, M.D
• Phone: +86 13724831279
• Email: hefangjnu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 626
• Est. completion date: February 27, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

Diagnostic Test:
• blood 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).

Other:
• Clinical 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.

Locations

Country	Name	City	State
China	FANG HE	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
FANG HE

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preeclampsia	The criteria for preeclampsia were based on the Chinese Guidelines for the Diagnosis and Treatment of Hypertensive Disorders in Pregnancy (2020), 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, etc."	After 20 weeks of gestation until the end of delivery
Secondary	premature delivery	Preterm infants were defined as all live born newborns with gestational age < 37 weeks. According to the Preterm Health Care Standards, preterm infants were divided into: (1) low-risk preterm infants with gestational age =34 weeks and birth weight =2000g, without early severe complications and good weight gain in the early stage after birth; (2) High-risk preterm infants were defined as those with gestational age < 34 weeks or birth weight < 2000g, early complications or complications, feeding difficulties and slow weight gain.	After 20 weeks of gestation until the end of delivery
Secondary	fetal intrauterine growth restriction	fetal intrauterine growth restriction (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.	After 20 weeks of gestation until the end of delivery
Secondary	Severe complications of preeclampsia	(1) Uncontrolled persistently elevated blood pressure: systolic blood pressure =160 mmHg and/or diastolic blood pressure =110 mmHg; (2) persistent headache, visual impairment or other central nervous system abnormalities; (3) persistent upper abdominal pain and subcapsular hematoma or liver rupture; (4) Abnormal transaminase levels: elevated serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels; (5) Impaired renal function: proteinuria =2.0g/24h, oliguria (24-hour urine output < 400ml or hourly urine output < 17ml) or serum creatinine level > 106 umol/L; (6) Hypoproteinemia with ascites, pleural effusion or pericardial effusion; (7) Blood system abnormalities: persistent decrease of platelet count below 100×109/L, microvascular hemolysis, anemia, elevated blood lactate dehydrogenase level or jaundice; (8) heart failure; 9) pulmonary edema; (10) fetal growth restriction or oligohydramnios, intrauterine fetal death, placental abruption, etc.	After 20 weeks of gestation until the end of delivery