Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorFANG HE
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial population
All the subjects were pregnant women who delivered in our hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood pressure
Diagnostic testBased 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 screening
Other interventionIn 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.
Treatment groups
626 Participants
are divided into 4 treatment groupsGroup A: Main study objective Groups: normotensive group1 intervention
Group B: Main study objective Groups: Stage 1 hypertension group1 intervention
Group C: Secondary objective grouping: Stage 1 hypertension low-risk group2 interventions
Group D: Secondary objective grouping: Stage 1 hypertension high-risk group2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
After 20 weeks of gestation until the end of deliverySecondary outcomes
1
Preterm birth
Preterm birth were defined as live birth with gestational age \< 37 weeks.
Time frame
After 20 weeks of gestation until the end of delivery2
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.
Time frame
After 20 weeks of gestation until the end of delivery3
Severe complications of preeclampsia
hemolysis，elevated liver enzymes and low platelets count syndrome
Time frame
After 20 weeks of gestation until the end of deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
FANG HE
Lead sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Source ClinicalTrials.gov