Angiogenic Factors in the Conservative Management of Gestational Hypertension

Not Applicable

Recruiting

• Conditions: Gestational Hypertension
• Interventions: Diagnostic Test: Angiogenic factor

• Registration Number: NCT06123377
• Lead Sponsor: Saint Thomas Hospital, Panama

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 However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known.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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Study Start: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-08-15
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
37 weeks	Angiogenic factor	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.
39 weeks	Angiogenic factor	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.

Primary Outcome Measures

Name	Time	Method
Progression to preeclampsia	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 Outcome Measures

Name	Time	Method
Maternal / fetal morbidity	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).
Neonatal morbidity	Up until discharge. On average, 3 days	Presence of any/several indicators of neonatal morbidity (Apgar scores, admission to NICU, encephalopatic hypoxia)

Trial Locations

Locations (1)

Hospital Santo Tomas; 🇵🇦 Panama, Panama