Menu
Recruiting NCT06123377

Angiogenic Factors in the Conservative Management of Gestational Hypertension

No phase Interventional Gestational Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Angiogenic factor.
Who it may be relevant to
Registry conditions: Gestational Hypertension. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Panama
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Interventions

  • Diagnostic test Angiogenic factor
    sFLt-1/PGIF below or equal to 33

Primary outcome measures

  • Progression to preeclampsia [Time frame: From the moment of randomization up until delivery. Between 1 and 17 weeks.]
Secondary outcome measures (2)
  • Maternal / fetal morbidity [Time frame: Up until discharge. On average, 7 days]
  • Neonatal morbidity [Time frame: Up until discharge. On average, 3 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Panama · 1 center
  • Hospital Santo Tomas — Panama City

Identifiers

NCT: NCT06123377 · FA022023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗