Angiogenic Factors in the Conservative Management of Gestational Hypertension

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

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Hypertension
• Intervention / Treatment: Diagnostic test: Angiogenic factor

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osvaldo Reyes, MD; Phone Number: +507 65655041; Email: oreyespanama@yahoo.es
• Study Contact Backup: Name: Gerado Cardenas, MD; Email: drgacardenas@hotmial.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 39 weeks; 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; sFLt-1/PGIF below or equal to 33
Active Comparator: 37 weeks; 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; sFLt-1/PGIF below or equal to 33

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Gestational hypertension; Angiogenic factors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Angiogenesis Modulating Agents; Growth Substances; Angiogenesis Inducing Agents
• Other Study ID Numbers: FA022023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No