Angiogenic Factors in the Conservative Management of Gestational Hypertension

Study Overview
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Brief Summary
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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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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.

Official Title
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Use of Angiogenic Factors in the Conservative Management of Gestational Hypertension. Prospective, Randomised, Controlled Study.

Conditions
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Gestational Hypertension

Intervention / Treatment
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* Diagnostic Test: Angiogenic factor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 39 weeks<br>Patients with gestational hypertension and angiogenic factors (sFlt-1/PIGF) below 33 will be evaluated weekly until 39 weeks, when termination of pregnancy will be scheduled. | Diagnostic Test: Angiogenic factor<br>* sFLt-1/PGIF below or equal to 33<br>|
| Active Comparator: 37 weeks<br>Patients with gestational hypertension and angiogenic factors (sFlt-1/PIGF) below 33 will be evaluated weekly until 37 weeks, when termination of pregnancy will be scheduled. | Diagnostic Test: Angiogenic factor<br>* sFLt-1/PGIF below or equal to 33<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Neonatal morbidity | Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalopatic hypoxia) | Up until discharge. On average, 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational hypertension, Angiogenic factors