Angiogenic Factors in the Conservative Management of Gestational Hypertension

NCT ID: NCT06123377

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-09-30

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Conditions

Gestational Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Angiogenic factor

Intervention Type: DIAGNOSTIC_TEST

sFLt-1/PGIF below or equal to 33

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.

Group Type: ACTIVE_COMPARATOR

Angiogenic factor

Intervention Type: DIAGNOSTIC_TEST

sFLt-1/PGIF below or equal to 33

Interventions

Angiogenic factor

sFLt-1/PGIF below or equal to 33

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Thomas Hospital, Panama

OTHER

Sponsor Role: lead

Responsible Party

Osvaldo A. Reyes T.

Head of the research deparment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Santo Tomas

Panama City, Provincia de Panamá, Panama

Site Status: RECRUITING

Countries

Panama

Central Contacts

Osvaldo Reyes, MD

Role: CONTACT

oreyespanama@yahoo.es

+507 65655041

Gerado Cardenas, MD

Role: CONTACT

drgacardenas@hotmial.com

Facility Contacts

Osvaldo Reyes, MD

Role: primary

oreyespanama@yahoo.es

50765655041

Gerardo Cardenas, MD

Role: backup

drgacardenas@hotmail.com

Other Identifiers

FA022023

Identifier Type: -

Identifier Source: org_study_id