Gestational HypertensionNCT06123377
Angiogenic Factors in the Conservative Management of Gestational Hypertension
A study testing Angiogenic factor in people with Gestational Hypertension, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Angiogenic factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePanama
- Study dates
- 1 Jun 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gerado Cardenas, MD contact
Panama1 site, 1 recruiting
- Recruiting
Hospital Santo Tomas
Panama City, Provincia de Panamá, 0834-1439
Osvaldo Reyes, MD, 50765655041, oreyespanama@yahoo.es
Gerardo Cardenas, MD, drgacardenas@hotmail.com
About this study
Official title: 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.
- Conditions
- Gestational Hypertension
- Being tested
- Angiogenic factor
- Keywords
- Gestational hypertension, Angiogenic factors
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiogenic factorDiagnostic test
sFLt-1/PGIF below or equal to 33
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Angiogenic factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the moment of randomization up until delivery. Between 1 and 17 weeks.
Secondary outcomes (2)
Maternal / fetal morbidity
Presence of any/several indicators of maternal or fetal morbidity (abruptio placenta, HELLP syndrome, eclampsia, fetal growth restriction, acute lung edema).
Measured: Up until discharge. On average, 7 days
Neonatal morbidity
Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalopatic hypoxia)
Measured: Up until discharge. On average, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Jun 2024
- Primary completion15 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123377
- Sponsor's protocol ID
- FA022023
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Angiogenic Factors in the Conservative Management of Gestational Hypertension. Prospective, Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT06123377
- Acronym / sponsor ID
- FA022023
- Conditions
- Gestational Hypertension
- Keywords
- Gestational hypertension, Angiogenic factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 39 weeks | Experimental | Diagnostic Test: Angiogenic factorPatients 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. |
| 37 weeks | Active comparator | Diagnostic Test: Angiogenic factorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Multiple gestation
- Maternal vasculitis
- Previous cesarean section (3 or more)
- Neurological conditions
- Chronic renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiogenic factorsFLt-1/PGIF below or equal to 33 | Diagnostic test | 37 weeks, 39 weeks |
Primary outcome
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
2 secondary outcomes
Maternal / fetal morbidity
Time frame: Up until discharge. On average, 7 days
Neonatal morbidity
Time frame: Up until discharge. On average, 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerado Cardenas, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiogenic factor in people with Gestational Hypertension, run by Saint Thomas Hospital, Panama at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osvaldo Reyes, MD (+507 65655041, oreyespanama@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to preeclampsia (time frame: From the moment of randomization up until delivery. Between 1 and 17 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.