NCT06123377

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jun 2024Sep 2026

First Submitted

Initial submission to the registry

October 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

October 29, 2023

Last Update Submit

August 23, 2025

Conditions

Gestational Hypertension

Keywords

Gestational hypertensionAngiogenic factors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Maternal / fetal morbidity

    Up until discharge. On average, 7 days

  • Neonatal morbidity

    Up until discharge. On average, 3 days

Study Arms (2)

39 weeks

EXPERIMENTAL

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

37 weeks

ACTIVE COMPARATOR

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

Interventions

Angiogenic factorDIAGNOSTIC_TEST

sFLt-1/PGIF below or equal to 33

37 weeks39 weeks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santo Tomas

Panama City, Provincia de Panamá, 0834-1439, Panama

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Osvaldo Reyes, MD

CONTACT

+507 65655041oreyespanama@yahoo.es

Gerado Cardenas, MD

CONTACT

drgacardenas@hotmial.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the research deparment

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 8, 2023

Study Start

June 1, 2024

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

PA(1)