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NCT Number: NCT06123377

Angiogenic Factors in the Conservative Management of Gestational Hypertension

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiogenic factor

Diagnostic Test

sFLt-1/PGIF below or equal to 33

Primary outcomes

  1. 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

  1. Maternal / fetal morbidity

    Time frame: Up until discharge. On average, 7 days

    Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).

  2. Neonatal morbidity

    Time frame: Up until discharge. On average, 3 days

    Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalopatic hypoxia)

Study contacts

Contact information is provided by the study sponsor or research team.

Gerado Cardenas, MD

CONTACT

[email protected]

Osvaldo Reyes, MD

CONTACT

[email protected]

+507 65655041

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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