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Clinical Trials/NCT06123377
NCT06123377
Recruiting
Not Applicable

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

Saint Thomas Hospital, Panama1 site in 1 country150 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Hypertension
Sponsor
Saint Thomas Hospital, Panama
Enrollment
150
Locations
1
Primary Endpoint
Progression to preeclampsia
Status
Recruiting
Last Updated
8 months ago

Overview

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
September 30, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Saint Thomas Hospital, Panama
Responsible Party
Principal Investigator
Principal Investigator

Osvaldo A. Reyes T.

Head of the research deparment

Saint Thomas Hospital, Panama

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
  • Heart disease
  • Index sFlt-1/PIGF of 34 or more

Outcomes

Primary Outcomes

Progression to preeclampsia

Time Frame: From the moment of randomization up until delivery. Between 1 and 17 weeks.

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

Secondary Outcomes

  • Maternal / fetal morbidity(Up until discharge. On average, 7 days)
  • Neonatal morbidity(Up until discharge. On average, 3 days)

Study Sites (1)

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