Angiogenic Factors in the Conservative Management of Gestational Hypertension

Saint Thomas Hospital (HST)

Status: Enrolling

Conditions: Gestational Hypertension

Treatments: Diagnostic Test: Angiogenic factor

Study type: Interventional

Funder types: Other

Identifiers

NCT06123377

FA022023

Details and patient eligibility

About

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

39 weeks

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Angiogenic factor

37 weeks

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Angiogenic factor