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

July 2, 2024 updated by: FANG HE
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
626

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After 20 weeks of gestation until the end of delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preterm birth
Time Frame: After 20 weeks of gestation until the end of delivery
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)
Time Frame: After 20 weeks of gestation until the end of delivery
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
Time Frame: After 20 weeks of gestation until the end of delivery
hemolysis，elevated liver enzymes and low platelets count syndrome
After 20 weeks of gestation until the end of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FANG HE

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fang He, M.D, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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