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

NCT06339749 | Recruiting DMC

• 1 other identifier: [2024] Ethics Review NO.040
• Study Type: observational
• Target: 626
• Locations: 1 country
• Sites: 1

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.

Conditions

stage1 Hypertension; Preeclampsia

Keywords

stage1 hypertension; Preeclampsia; observation; pregnancy outcomes

Outcome Measures

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.

  After 20 weeks of gestation until the end of delivery

Secondary Outcomes (3)

• Preterm birth

  After 20 weeks of gestation until the end of delivery

• fetal intrauterine growth restriction (FGR)

  After 20 weeks of gestation until the end of delivery

• Severe complications of preeclampsia

  After 20 weeks of gestation until the end of delivery

Study Arms (4)

Main study objective Groups: normotensive group

Main study objective Groups: normotensive group

Diagnostic Test: blood pressure

Main study objective Groups: Stage 1 hypertension group

Main study objective Groups: Stage 1 hypertension group

Diagnostic Test: blood pressure

Secondary objective grouping: Stage 1 hypertension low-risk group

Secondary objective grouping: Stage 1 hypertension low-risk group

Diagnostic Test: blood pressure; Other: Clinical protocols for preeclampsia risk screening

Secondary objective grouping: Stage 1 hypertension high-risk group

Secondary objective grouping: Stage 1 hypertension high-risk group

Diagnostic Test: blood pressure; Other: Clinical protocols for preeclampsia risk screening

Interventions

blood pressure DIAGNOSTIC_TEST

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; Main study objective Groups: normotensive group; Secondary objective grouping: Stage 1 hypertension high-risk group; Secondary objective grouping: Stage 1 hypertension low-risk group

Clinical protocols for preeclampsia risk screening OTHER

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; Secondary objective grouping: Stage 1 hypertension low-risk group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;
• Sign informed consent.

You may not qualify if:

• Underlying diseases (chronic hypertension, type 1 or type 2 diabetes, kidney disease, autoimmune disease).

Sponsors & Collaborators

• FANG HE: lead

Study Sites (1)

FANG HE

Guangzhou, Guangdong, 510150, China

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Pressure; Clinical Protocols

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Fang He, M.D

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang He, M.D

CONTACT

+86 13724831279; hefangjnu@126.com

Yafei Wang, Master

CONTACT

+86 18716442633; 542114919@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician/Professor of the Obstetrics Department

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 25, 2024
• Primary Completion: June 30, 2025
• Study Completion: February 27, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)