Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339749
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-25
Brief Title:
Pregnancy Outcomes in Normotensive VS stage1 Hypertension a Prospective Observational Study
Sponsor:
FANG HE
Organization:
The Third Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Pregnancy Outcomes in Normotensive VS stage1 Hypertension a Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor diastolic BP 80-89 mmHg on at least two occasions without a diagnosis of chronic hypertension andor 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 httpsfetalmedicineorgresearchassesspreeclampsiafirst-trimester The individual risk of preterm PE was calculated at 11-141 weeks of gestation using the British Fetal Medicine Foundation FMF algorithm Previous risk was calculated based on maternal demographic characteristics and obstetric history Therefore 1100 was selected as the cut-off value 1100 was registered as high risk of preeclampsia 1100 was registered as low risk of preeclampsia For people with high risk of preeclampsia 1100 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None