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Can tighter blood pressure control in pregnancy prevent serious complications?

NCT ID NCT07746271

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This trial tests whether treating high blood pressure in pregnancy to a stricter target (below 140/90) is better than the usual approach (below 160/110) for women with gestational hypertension or preeclampsia without severe features. About 4,120 pregnant women will be randomly assigned to one of the two blood pressure goals. The study tracks whether the stricter goal reduces a combined set of serious outcomes, including organ damage, early delivery, fetal or infant death, and placental abruption.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Antihypertensive medication (labetalol or nifedipine ER) titrated to a blood pressure goal of <140/90 mmHg
What this could lead to
If tighter blood pressure control works, it could reduce serious pregnancy complications like preterm birth and organ damage in women with gestational hypertension or preeclampsia.
What could go wrong
The trial is large but open-label, and the tighter goal may increase side effects from medication without improving outcomes. Results are not yet available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4,120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 56 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * Known allergy or hypersensitivity 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 washout 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 platelet 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brown Univeristy

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44109, United States

  • Columbia University

    New York, New York, 10032, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Regents of the University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas - Houston

    Houston, Texas, 77030, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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