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Not yet recruitingNCT07746271GOALPOSTUpdated Sep 18, 2026

Gestational Hypertension and Preeclampsia Blood Pressure (BP) Treatment Goals Less Than 140/90 vs. Less Than 160/110 mmHg: The GOALPOST Trial

A Phase 3 interventional study of Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg and Usual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHg in Hypertension in Pregnancy and Obstetrical Complications, sponsored by The George Washington University Biostatistics Center. Not yet recruiting at 14 sites in United States. Open to female participants aged 14 Years to 56 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Primary conditionPre-EclampsiaRegistry: Hypertension, Pregnancy-InducedReclassifiedWhy we changed it
Registry
Hypertension, Pregnancy-Induced — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pre-Eclampsia
Why
  1. The study's title name Pre-Eclampsia, a narrower term within Hypertension, Pregnancy-Induced.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The George Washington University Biostatistics Center · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
4,120
Allocation
Randomized
Ages
14 Years to 56 Years
Sex
Female
01

Study summary

This is a phase-III multi-center open-label randomized clinical trial of 4,120 individuals between 23 weeks, 0 days and 35 weeks, 6 days gestation with gestational hypertension or preeclampsia without severe features randomized to antihypertensive medication to a target blood pressure (BP) of \<140/90 mmHg or to no treatment for non-severe hypertension \< 160/110 mmHg (usual care). The primary endpoint is an adverse pregnancy composite comprised of preeclampsia with end-organ damage, medically indicated preterm delivery \<37 weeks 0 days gestation, fetal/neonatal/infant death, or placental abruption.

Read the detailed description

All women with a diagnosis of gestational hypertension or preeclampsia without severe features at an Maternal-Fetal Medicine Units Network (MFMU) Center outpatient or inpatient setting who are less than 36 weeks and 0 days of gestation will be screened for eligibility and approached for enrollment by the MFMU Research Team. Women who meet study eligibility and want to participate will provide written informed consent. Study participants will be randomized 1:1 to:

  1. intervention: antihypertensive medication to achieve a target blood pressure (BP) lower than 140/90 mmHg or
  2. usual care: defined as no antihypertensive medication unless BP increases to greater than or equal to 160 mmHg systolic pressure or 110 mmHg diastolic to achieve a target BP of less than 160/110 mmHg.

Participants randomized to intervention will be initiated on labetalol or nifedipine extended release (ER). For first line treatment with labetalol, 200 mg twice daily will be initiated and escalated according to institutional protocol to a BP goal of \<140/90 to a maximum dose of 2,400 mg/day (1,200 mg twice daily or 800 mg three time daily). Alternatively, for first line treatment with nifedipine ER, nifedipine ER will be initiated at 30 mg daily and escalated according to institutional protocol to a goal BP \<140/90 to a maximum dose of 120 mg/day (120 mg daily or 60 mg twice daily).

Participants will be seen clinically at least weekly until delivery. All participants will have an encounter with research staff twice a week from randomization until delivery.

Each encounter (twice a week) should include the following:

  • Maternal symptom assessment including evaluation for new headaches, changes in vision, abdominal pain, vaginal bleeding, and/or decreased fetal movement
  • Side effects and adverse events assessment

At least one per week, research staff should perform the following:

  • Record and review all clinic blood pressures and laboratory evaluations
  • Record changes to antihypertensive medications
  • Record unscheduled emergency room (ER) visits, Labor and Delivery (L\&D) visits or hospitalizations
  • For participants in the intervention group, research staff should confirm their prescription for study medication will ensure an adequate supply until their next visit, and assess compliance.

One to two weeks after randomization, the participant should complete the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) to assess quality of life. Fetal surveillance (e.g., biophysical profile, or non-stress test with or without amniotic fluid assessment) should be performed clinically at least weekly per local standard of care. Ultrasonographic fetal growth assessment should be performed clinically at least every 4 weeks to assess fetal growth. If fetal growth restriction is identified, increased surveillance with umbilical artery Dopplers will be initiated per institutional protocol.

Maternal and neonatal outcomes will be abstracted from the medical records following the delivery hospitalization. Newborn assessment will include the duration of hospitalization up to 6 weeks of life. A single maternal follow-up study visit at 6 weeks (range 4-8) weeks postpartum will be scheduled to ascertain maternal, neonatal, and resource use outcomes.

02

Conditions studied

  • Hypertension in Pregnancy
  • Obstetrical Complications

Browse trials for

Keywords

  • Preeclampsia
  • Preterm Delivery
  • Maternal Morbidity
  • Neonatal Morbidity
  • Prevention
03

In context

Pre-Eclampsia Reclassified

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 4,120 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

The George Washington University Biostatistics Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Compared within Pre-Eclampsia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Pregnancy-Induced. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
14 Years to 56 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Singleton or di-chorionic twin gestation.
  • Gestational age at randomization from 23 weeks 0 days through 35 weeks 6 days based on clinical information and evaluation of the earliest ultrasound

  • Diagnosis of gestational hypertension or preeclampsia without severe features within 10 days prior to randomization.

    • Gestational hypertension or preeclampsia is defined as new onset systolic blood pressure 140-159 or diastolic blood pressure 90-109 (or both) on two occasions at least four hours apart on or after 20 weeks 0 days gestation with normal end-organ labs, with or without proteinuria.
    • Blood pressure measurements used for the diagnosis must occur during a formal clinical assessment in the outpatient, inpatient, or emergency care setting and be documented in the medical record. The diagnosis is made on the date of the second qualifying blood pressure.
    • At least 1 elevated blood pressure (systolic blood pressure 140-159 and/or diastolic blood pressure 90-109) must be documented at the recruitment site

Exclusion criteria

EXCLUSION CRITERIA:

  • Known allergy or to both labetalol and nifedipine ER
  • Two blood pressure measurements ≥ 140/90 at least 4 hours apart prior to 20 weeks 0 days in the current pregnancy

  • History or current use of anti-HTN medication defined as any of the following:

    • Prescribed anti-HTN medication 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 is not an exclusion.
    • Current use of anti-HTN medication. Participants on anti-HTN medication for the purpose of treating non-severe hypertensive disorders of pregnancy, or for indications other than hypertension, who are willing to go through a 48 hour before randomization would be eligible.

  • High-risk co-morbidities for which treatment at a lower blood pressure level (i.e., below the standard cutoff of 160/110) may be indicated

    • Chronic kidney disease including any of the following lab values prior to 20 weeks gestation: proteinuria ≥ 300mg/24 hr, clean catch protein creatinine ratio ≥ 0.3, or serum creatinine >1.1
    • Cardiac disorders including cardiomyopathy, angina, and coronary artery disease
    • Prior stroke
    • Retinopathy
    • Sickle cell disease

Preeclampsia with severe features defined as any of the following:

  • Severe hypertension defined as new onset systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 110 on two occasions at least 4 hours apart (unless antihypertensive medication is initiated before this time) on or after 20 weeks 0 days gestation.

  • Severe features of preeclampsia as evidenced by end organ damage defined as any of the following on or after 20 weeks 0 days gestation:

    • Thrombocytopenia defined as a count \<100,000
    • Renal insufficiency defined as a serum creatinine >1.1 mg/dL or a doubling of the concentration in the absence of other renal disease
    • Impaired liver function defined as an elevated blood concentration of liver transaminases to twice normal concentration, or by severe persistent right upper quadrant or epigastric pain
    • Pulmonary edema
    • New onset headache unresponsive to medication and not accounted for by alternative diagnoses
    • Visual disturbances

  • Eclampsia

    • Oligohydramnios defined as a maximum vertical pocket (MVP) \<2 cm or an amniotic fluid index (AFI) \< 5 cm
    • Fetal growth restriction defined as estimated fetal weight \< 5th percentile, or fetal growth restriction \<10th percentile (estimated fetal weight \<10th percentile or abdominal circumference \< 10th percentile) with abnormal umbilical artery dopplers (elevated (S/D ratio >95th percentile for gestational age), absent or reversed end diastolic flow)
    • Known fetal genetic disease or major malformations
    • Fetal demise or planned termination of pregnancy.
    • Planned indicated delivery prior to 37 weeks 0 days
    • Participation in another interventional study that influences the primary outcome in this study. This may not apply to comparative effectiveness studies evaluating treatments that are available and used as part of clinical practice. Such cases will be adjudicated by the Concurrent Research Committee and Protocol Subcommittee.
    • Plan to deliver at a non-participating site
    • Participation in this trial in a previous pregnancy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,120 participants (estimated)

Study arms

  • Experimental
    Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg

    Drug: Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg

  • Other
    Usual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHg

    Other: Usual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHg

Interventions

  • DrugAnti-hypertensive medication titrated to a BP goal of <140/90 mmHg

    Drug page: Labetalol

    Antihypertensive medication titrated to a BP goal of \< 140/90 mmHg initiated on labetalol or nifedipine ER following standard dosing guidelines. For first line treatment with labetalol, 200 mg twice daily will be initiated and escalated to a BP goal of \<140/90 mmHg to a maximum dose of 2,400 mg/day (1,200 mg twice daily or 800 mg three times daily). If a maximum daily dose of 2,400 mg or maximal tolerated dose of labetalol is reached without achieving goal BP \<140/90 mmHg, or at provider discretion, nifedipine ER can be added as a second agent and titrated as per the nifedipine ER algorithm outlined below. For first line treatment with nifedipine ER, dosing will be initiated at 30 mg daily and escalated to a goal BP \<140/90 mmHg to a maximum dose of 120 mg/day (120 mg daily or 60 mg twice daily). If the maximum daily dose or maximal tolerated dose of nifedipine ER is reached without achieving goal BP \<140/90, or at provider discretion, labetalol can be added as described above.

    Also known as: Labetalol, Nifedipine ER

  • OtherUsual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHg

    Usual care will not receive anti-hypertensive medication upon randomization. Participants will only be prescribed antihypertensive medication if their BP increases to ≥160/110 mmHg and titrated to a BP goal of \<160/110 mmHg. They will receive IV and/or oral anti-hypertensive medication as per local institutional protocols for management of severe range BP.

06

What researchers measure

Primary outcomes

  1. Number of participants with the adverse pregnancy composite

    Number of participants with preeclampsia with severe features (excluding severe hypertension), medically indicated preterm birth less than 37 weeks 0 days, fetal or neonatal death, placental abruption.

    Time frame: Randomization to 6 weeks postpartum / 6 weeks of life (a period of up to 23 weeks)

Secondary outcomes

  1. Number of participants with the adverse perinatal composite outcome

    Adverse perinatal composite defined as any one of the following: respiratory distress syndrome, 5-minute Apgar score less than or equal to 3, seizure, confirmed sepsis, Intraventricular hemorrhage (Grade 3-4), Bronchopulmonary dysplasia (Grade 3 or higher), necrotizing enterocolitis (Bell Stage greater than or equal to 2A), treated hyperbilirubinemia, treated hypoglycemia, hypoxic ischemic encephalopathy, fetal/neonatal/infant death

    Time frame: Randomization to 6 weeks of life (a period of up to 23 weeks)

  2. Number of participants with preeclampsia with severe features

    Number of participants with preeclampsia with severe features defined using American College of Obstetricians and Gynecologists 2020 criteria through 6 weeks postpartum.

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  3. Number of perinatal deaths

    Number of fetal or neonatal deaths through 28 days of life

    Time frame: Randomization to 28 days of life (a period of up to 147 days)

  4. Number of neonates who were small for gestational age <3rd percentile

    Number of neonates who were small for gestational age (SGA) defined as a birth weight \<3rd and \<10th percentile for gestational age as defined by Aris et al.

    Time frame: At birth

  5. Number of neonates who were small for gestational age <10th percentile for gestational age

    Number of neonates who were small for gestational age (SGA) defined as a birth weight \<10th percentile for gestational age as defined by Aris et al.

    Time frame: At birth

  6. Number of neonates with low birth weight

    Number of neonates with birth weight \<2,500g

    Time frame: At birth

  7. Number of participants with preterm births

    Number of participants with delivery of a fetus at less than 37 weeks for any reason or indication, includes spontaneous and iatrogenic preterm birth

    Time frame: From randomization to birth (a period of up to 14 weeks)

  8. Number of participants with spontaneous preterm birth

    Spontaneous delivery at less than 37 weeks 0 days gestation

    Time frame: From randomization to birth (a period of up to 14 weeks)

  9. Number of participants with severe hypertension

    Number of participants with systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 110 mmHg confirmed by at least one repeated measure within 4 hours unless antihypertensive medication was already initiated.

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  10. Number of participants with cesarean delivery

    Number of participants who had delivery of a fetus via an abdominal incision and hysterotomy

    Time frame: At delivery

  11. Number of participants with postpartum hemorrhage

    Number of participants with cumulative blood loss ≥ 1,000mL or any blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after delivery, regardless of delivery route

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  12. Number of maternal deaths

    Death of the mother for any reason through 6 weeks postpartum

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  13. Number of antepartum and postpartum clinic visits

    The number of antepartum and postpartum clinic visits (scheduled and unscheduled)

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  14. Number of Obstetric (OB) Triage / Emergency Room (ER) visits

    The number of times the participant sought care in the obstetric triage or emergency department through 6 weeks postpartum

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  15. Number of postnatal hospitalization days

    The number of days the participant was admitted to the hospital from delivery to discharge

    Time frame: From delivery to hospital discharge (no maximum time frame)

  16. Number of postpartum readmissions

    The number of times a participant is admitted to the hospital after she is discharged from the delivery-associated hospitalization through 6 weeks postpartum

    Time frame: From discharge from the delivery-associated hospitalization through 6 weeks postpartum (a period of up to 23 weeks)

  17. Number of antepartum hospitalization days

    The number of days the participant was admitted to the hospital from randomization to delivery

    Time frame: Randomization to delivery (a period of up to 17 weeks)

  18. Number of participants admitted to intensive care unit (ICU)

    Admission of the mother to an intensive care unit (ICU) through 6 weeks postpartum

    Time frame: Randomization to 6 weeks postpartum (a period of up to 23 weeks)

  19. Number of neonates admitted to neonatal intensive care unit (NICU)

    Admission of the neonate to an intensive care unit admission greater than or equal to 2 days through 6 weeks of life

    Time frame: Birth to 6 weeks of life

  20. Neonatal length of hospital stay

    Number of days from delivery to discharge

    Time frame: Birth to hospital discharge (no maximum timeframe)

  21. Number of neonatal hospital readmissions

    Number of times the neonate is admitted to the hospital from discharge to 6 weeks of life

    Time frame: Hospital discharge to 6 weeks of life

  22. Number of neonatal clinic visits

    Number of neonatal clinic visits

    Time frame: Hospital discharge to 6 weeks of life

  23. Number of neonatal emergency room (ER) visits

    Number of neonatal emergency room (ER) visits

    Time frame: Hospital discharge to 6 weeks of life

Other outcomes

  1. Number of participants with adverse pregnancy composite by race/ethnicity

    NIH-required analysis. Number of participants with preeclampsia with severe features (excluding severe hypertension), medically indicated preterm birth less than 37 weeks 0 days, fetal or neonatal death, placental abruption.

    Time frame: Randomization to 6 weeks postpartum / 6 weeks of life

07

Study locations

14 sites
08

References and documents

Individual participant data

Plan to share: Yes — Data will be shared via NICHD DASH in accordance with NIH policy

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Aug 5, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Apr 30, 2030
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07746271
Lead sponsor
The George Washington University Biostatistics Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Alabama at Birmingham, University of Utah, Brown University
Responsible party
Sponsor
First posted
Aug 5, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Sep 18, 2026

Study contacts

Rebecca G Clifton, PhD
Contact
rclifton@bsc.gwu.edu
202-242-2945
Roja Kambhampati, MSHS
Contact
Rebecca G Clifton, PhD
principal investigator · The George Washington University Biostatistics Center
Rachel G Sinkey, MD
study chair · University of Alabama at Birmingham
Laurie B Griffin, MD
study chair · University of Utah Health Sciences
Dwight J Rouse, MD
principal investigator · Brown University
Alan TN Tita, MD PHD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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