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

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; stage1 Hypertension
• Intervention / Treatment: Diagnostic test: blood pressure; Other: Clinical protocols for preeclampsia risk screening

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 Type: Observational
• Enrollment (Estimated): 626

Contacts and Locations

• Study Contact: Name: Fang He, M.D; Phone Number: +86 13724831279; Email: hefangjnu@126.com
• Study Contact Backup: Name: Yafei Wang, Master; Phone Number: +86 18716442633; Email: 542114919@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510150
      • Recruiting
      • Fang He
      • Contact: Fang He, M.D; Phone Number: +86 13724831279; Email: hefangjnu@126.com
      • Contact: Yafei Wang, Master; Phone Number: +86 18716442633; Email: 542114919@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All the subjects were pregnant women who delivered in our hospital.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main study objective Groups: normotensive group	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).
Main study objective Groups: Stage 1 hypertension group	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).
Secondary objective grouping: Stage 1 hypertension low-risk group	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.
Secondary objective grouping: Stage 1 hypertension high-risk group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 20 weeks of gestation until the end of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth	Preterm birth were defined as live birth with gestational age < 37 weeks.	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.	After 20 weeks of gestation until the end of delivery
Severe complications of preeclampsia	hemolysis，elevated liver enzymes and low platelets count syndrome	After 20 weeks of gestation until the end of delivery

Collaborators and Investigators

• Sponsor: FANG HE
• Investigators: Principal Investigator: Fang He, M.D, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): February 27, 2026

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Preeclampsia; pregnancy outcomes; observation; stage1 hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Pre-Eclampsia
• Other Study ID Numbers: [2024] Ethics Review NO.040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No