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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06123377
Other study ID # FA022023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source Saint Thomas Hospital, Panama
Contact Osvaldo Reyes, MD
Phone +507 65655041
Email oreyespanama@yahoo.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. One of the most controversial scenarios is gestational hypertension, a group of hypertensive disorders considered the mildest form of the pre-eclamptic spectrum, where current recommendations indicate termination of pregnancy at 37 weeks. However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known. The purpose of the study is to use angiogenic factors as a guide to decide the most appropriate gestational age for termination of pregnancy in patients diagnosed with gestational hypertension.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date September 30, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women between 24 and 40 weeks of gestation. - Diagnosis of Gestational Hypertension based on ACOG criteria - index sFlt-1/PIGF equal or below 33 Exclusion Criteria: - Multiple gestation - Maternal vasculitis - Previous cesarean section (3 or more) - Neurological conditions - Chronic renal disease - Purpura - Heart disease - Index sFlt-1/PIGF of 34 or more

Study Design


Intervention

Diagnostic Test:
Angiogenic factor
sFLt-1/PGIF below or equal to 33

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Saint Thomas Hospital, Panama

Outcome

Type Measure Description Time frame Safety issue
Primary Progression to preeclampsia In subject with gestational hypertension and sFlt-1/PIGF at enrollment equal or below 33, the appearance of proteinuria, severe criteria or sFlt-1/PIGF above 34 From the moment of randomization up until delivery. Between 1 and 17 weeks.
Secondary Maternal / fetal morbidity Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema). Up until discharge. On average, 7 days
Secondary Neonatal morbidity Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalopatic hypoxia) Up until discharge. On average, 3 days
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