DISPATCH: Decreasing Intervention Using sFlt-1/PlGF Applied to Chronic Hypertension (DISPATCH)

Decreasing Intervention Using sFlt-1/PlGF Applied to Chronic Hypertension (DISPATCH Trial): A Pilot, Open-label, Randomized Controlled Trial

This pilot study tests the feasibility of conducting an interventional study in pregnant people with chronic hypertension with interventional clinical management based on sFlt-1/PlGF. It will also collect data on time to delivery, the incidence of preterm delivery, and other maternal or neonatal complications, for a pivotal trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Preeclampsia; Chronic Hypertension Complicating Pregnancy
• Intervention / Treatment: Diagnostic test: sFlt/PlGF without change in clinical care; Diagnostic test: sFlt/PlGF lab assay with change in clinical care

Detailed Description

Participants with chronic hypertension between 23+0 and 34+6 weeks presenting to triage for rule out superimposed preeclampsia. They will be randomly assigned to two groups at a 1:1 ratio, conceal or reveal, and will be tested with the sFlt-1/PlGF assay. In the conceal group, participants will have their blood tested but the results will not be returned to the participants or their clinical providers, and thus the participants will continue to receive routine clinical care in pregnancy. In the reveal group, the clinical team will be notified of the assay results (PlGF and sFlt-1 concentrations and ratio) and result status (normal <40 or abnormal using the cut-off ≥40) and will be encouraged to discharge patients with a normal result. The ultimate decision to admit or discharge will still be based on the decision making of the clinical team; if a patient with a normal result is admitted and/or delivered, the clinical team will be asked to record the reason(s) behind the decision(s). Repeat PlGF and sFlt-1 concentration and ratio testing will occur for participants who re-present to triage ≥7 days from the prior test, and on a weekly basis for participants who are admitted. For participants in the reveal group who have had an abnormal result, additional concentration and ratio testing will be performed but results will not be reported to the clinical team.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ophelia Yin, MD; Phone Number: (415) 894-9416‬; Email: ophelia.yin@ucsf.edu
• Study Contact Backup: Name: Alison Wenz; Phone Number: 415-502-3344; Email: Alison.Wenz@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18 and older

• Singleton living pregnancy

• Gestational age between 23+0 and 34+6 weeks gestation, confirmed by a fetal crown-rump length measurement in a first trimester ultrasound or by in vitro fertilization dates

• Chronic hypertension, defined as:

  • At least 2 blood pressure measurements 140 systolic or 90 diastolic 4 hours apart diagnosed at less than 20 weeks 0 days of gestation and within 12 months of conception.
  • History or current use of anti-hypertensive medications for the indication of lowering blood pressure within 12 months prior to conception or prior to 20 weeks 0 days in the current pregnancy. Use during a prior pregnancy and through 12 weeks postpartum, or use for stage 1 chronic hypertension are not exclusions.

• Evaluated in triage for worsening chronic hypertension, rule out preeclampsia due to:

  • Worsening blood pressures from baseline and/or development of severe range blood pressures
  • Preeclampsia associated symptoms: headache, vision changes, abdominal pain
  • New onset proteinuria or worsening proteinuria
  • Lab abnormalities suspicious for preeclampsia including anemia, signs of hemolysis, thrombocytopenia, increasing serum creatinine, elevated liver function tests
  • Any other concerning features of preeclampsia according to the evaluating clinician

Exclusion Criteria:

• Hemolysis, elevated liver enzymes, low platelet syndrome (HELLP syndrome), pulmonary edema, eclamptic seizure, stroke, myocardial infarction, placental abruption, or heart failure.
• Absent or reversed end-diastolic flow in the umbilical artery Doppler
• Unable to consent
• Major birth defect or chromosomal abnormality that may necessitate preterm birth for other reasons
• Other pregnancy complication that may necessitate preterm birth (e.g., PPROM)
• IV Heparin use within 24 hours of the lab draw
• Exogenous PlGF-2 or PlGF-3 given for therapeutic use at a concentration higher than 100 pg/mL

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conceal arm; The clinical team will be blinded to assay results and will manage as per their usual clinical protocol.	Diagnostic test: sFlt/PlGF without change in clinical care; Diagnostic testing with sFlt/PlGF assay at each obstetric emergency room or admission in which the participant is being evaluated for preeclampsia. Testing will occur at each evaluation or if the participant is admitted to the hospital, weekly. Conceal arm: The clinical team will be blinded to assay results and will manage chronic hypertension as per their usual clinical protocol.
Experimental: Reveal arm; The clinical team will receive qualitative assay results normal (sFlt-1/PlGF <40) or abnormal (sFlt-1/PlGF ³40)) and the ratio value and concentrations of PlGF and sFlt-1.	Diagnostic test: sFlt/PlGF lab assay with change in clinical care; Diagnostic testing with sFlt/PlGF assay at each obstetric emergency room or admission in which the participant is being evaluated for preeclampsia. Testing will occur at each evaluation or if the participant is admitted to the hospital, weekly. Reveal arm: the clinical team will receive qualitative assay results normal (sFlt-1/PlGF <40) or abnormal (sFlt-1/PlGF >=40).; If normal, the clinical team will be encouraged to manage the patient expectantly, with discharge home and routine outpatient surveillance or if the patient is admitted, to continue expectant management without delivery. If a patient with a normal result is admitted and/or delivered, the clinical team will be asked to record the reason(s) behind the decision(s).; If abnormal, the clinical team should consider superimposed preeclampsia and will manage per their usual clinical protocol. If a patient with an abnormal result is discharged, the clinical team will be asked to record the reason(s) behind the decision(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number of participants enrolled per week	At month 6
Protocol adherence in the reveal arm	What proportion of participants in the reveal arm adhered to the clinical algorithm of management based on the assay result.	At month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until delivery using a time-to-event analysis	Assessing weeks from the initial enrollment in the trial to delivery	From date of randomization until the date of delivery
Delivery with superimposed preeclampsia with severe features.	The endpoint will be analyzed for different follow-up times including <35 weeks of gestation. Analysis will take into account the potentially diverging directions of the effect in the patient strata of ratio results (levels: "abnormal", "normal"; cut-off 40; assuming reduction of deliveries in the "normal" stratum and increase in the "abnormal" stratum due to improved risk stratification by the ratio), e.g. by using (a) regression modelling with interaction term study arm x ratio result, or (b) stratification of the analysis by ratio result.	At the date of delivery
Rate of preterm birth at <35 weeks		At month 6
Rate of preterm birth at <37 weeks		At month 6
Maternal admission rate	1) defined as the number of participants admitted at least once in the antepartum period divided by the total number of participants in that arm of the trial and 2) defined as the number of participants admitted at least once in the postpartum period divided by the total number of participants in that arm of the trial	At month 6
Maternal admission days	Defined 1) randomization to delivery and 2) in the postpartum period up to 6 weeks	Date of randomization to 6 weeks postpartum
Maternal admission to the ICU	1) in pregnancy or 2) within 6 weeks postpartum	Date of randomization to 6 weeks postpartum
Severe maternal morbidity (with and without transfusion)	Severe maternal morbidity (without transfusion) is defined as the occurrence of at least one of the following during pregnancy, delivery, or in the first 6 weeks postpartum: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest or conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, hemorrhagic or embolic stroke, pulmonary edema, severe anesthesia complication, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism, hysterectomy, temporary tracheostomy, mechanical ventilation	Date of randomization to 6 weeks postpartum
Gestational age at delivery		Date of delivery
Birthweight		Date of delivery
Birthweight percentile		Date of delivery
Mode of delivery		Date of delivery
Neonatal admission to the NICU		Date of delivery
Days of neonatal admission to the NICU		Date of delivery to 6 weeks postpartum
Neonatal composite morbidity	Neonatal major morbidity as measured in pregnancy and up to 6 weeks postpartum is defined as the occurrence of at least one of the following: death (fetal or neonatal death through 28 days postpartum), hypoxic ischemic encephalopathy, intraventricular hemorrhage, cardiopulmonary resuscitation, necrotizing enterocolitis, persistent pulmonary hypertension, bronchopulmonary dysplasia, mechanical ventilation, seizure, sepsis, birth trauma (fracture, brachial plexus injury, facial palsy); Neonatal minor morbidity as measured in pregnancy and up to 6 weeks postpartum is defined as the occurrence of at least one of the following: respiratory distress syndrome, hypoglycemia, meconium aspiration syndrome, and neonatal jaundice requiring phototherapy	Date of delivery to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Juan M Gonzalez Velez, MD PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 9, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; preeclampsia; chronic hypertension; sflt/plgf
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: STUDY00000922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes