Lowering blood pressure in pregnant women with hypertensive disorders to prolong pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ACHIEVE Trial is a randomized clinical trial aimed at determining whether lowering blood pressure to less than 140/90 mmHg in pregnant women with hypertensive disorders can extend the duration of pregnancy. This study focuses on women with gestational hypertension and preeclampsia who are less than 36 weeks pregnant and do not exhibit severe features of the condition. By administering antihypertensive treatment, the trial seeks to improve both maternal and fetal/neonatal outcomes by preventing preterm delivery. The findings from this trial could contribute to a better understanding of managing hypertension in pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant women
* Gestational age: 23 weeks, 0 days to 35 weeks, 6 days
* Hypertensive disorder of pregnancy including gestational hypertension or preeclampsia, the non-severe form at enrollment, which is called without severe features by the American College of Obstetricians and Gynecologists.
* No evidence of the severe form of preeclampsia, termed severe features, as outlined in maternal exclusions
* No indication for delivery at the time of enrollment.
* Planned expectant management at time of enrollment
* Singleton or dichorionic twin gestation, defined at and beyond 14 weeks gestation. (A pregnancy complicated by a vanishing twin in the first trimester defined as less than 14 weeks gestation will be eligible.)
* Intact membranes

Exclusion Criteria:

* Preeclampsia with severe features, defined per ACOG as:
* Systolic blood pressure of 160 mm Hg or more, or diastolic blood pressure of 110 mm Hg or more on two occasions at least 4 hours apart (unless antihypertensive therapy is initiated before this time)
* Thrombocytopenia defined as: lower than 100 x 10e9 platelets/L
* Impaired liver function that is not accounted for by alternative diagnoses and as indicated by abnormally elevated blood concentrations of liver enzymes (to more than twice the upper limit normal concentrations), or by severe persistent right upper quadrant or epigastric pain unresponsive to medications
* Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease)
* Pulmonary edema
* New-onset headache unresponsive to medication and not accounted for by alternative diagnoses
* Visual disturbances
* Underlying renal dysfunction defined as, presenting the following parameters prior to 20 weeks gestation: baseline creatinine, equal to or higher than, 1.2 mg/dL Or proteinuria: defined as presenting protein in urine, equal to or higher than, 300 mg/24 hours or protein/creatinine ratio, equal to or higher than, 0.3 or Urine dipstick reading of greater than or equal to 2 at baseline and in the absence of a urinary tract infection
* Stage 2 chronic hypertension
* Contraindications to labetalol and nifedipine XL according to the FDA package insert
* Patient unable to or unwilling to adhere to management recommendations
* Fetal Reasons for Study Ineligibility:
* Fetal growth restriction (lower than 10th percentile) at enrollment, based on an ultrasound within 3 weeks prior to enrollment
* Oligohydramnios defined by amniotic fluid deepest vertical pocket \<2 cm based on an ultrasound within the 48 hours prior to enrollment
* Known major structural or chromosomal abnormality

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Oschner
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Rachel Sinkey, MD — University of Alabama at Birmingham
• Study coordinator: Rachel Sinkey, MD
• Email: rsinkey@uabmc.edu
• Phone: 205-934-5611

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endothelial Biomarkers in Pregnancy: Endothelial Extracellular Vesicles and Hypertensive Disorders

  This study tests whether endothelial extracellular vesicles in the blood differ between normotensive pregnant women and those with hypertensive disorders of pregnancy.

  Recruiting Josip Juraj Strossmayer University of Osijek · Osijek · NCT07728656

• Postpartum high blood pressure: trying enalapril after delivery

  This study tests whether giving enalapril after delivery can help postpartum women with hypertensive disorders of pregnancy manage blood pressure.

  Recruiting Phase 3 Women and Infants Hospital of Rhode Island · Providence, Rhode Island · NCT07222852

• Community health worker support to lower blood pressure after pregnancy with high blood pressure

  Postpartum patients with high blood pressure after pregnancy will try a program where a trained community health worker helps them monitor blood pressure and manage care for 6 months to see if it lowers blood pressure compared with usual care.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07778966

• Progesterone to Prevent Preeclampsia in Early Pregnancy

  This trial tests whether nightly vaginal progesterone started before 12 weeks can lower the chance of preeclampsia in low-risk pregnant people.

  Recruiting Phase 4 Medical University of South Carolina · Charleston, South Carolina · NCT07448597

• Aspirin with or without low‑molecular‑weight heparin to prevent preeclampsia in high‑risk pregnancy

  This trial tests whether adding low‑molecular‑weight heparin (tinzaparin) to low‑dose aspirin reduces the chance of preeclampsia in pregnant people identified as high risk in the first trimester.

  Recruiting Phase 4 Alexandra Hospital, Athens, Greece · Athens, Attica · NCT07361679

• Blood markers (sFlt-1/PlGF, sEng, OPG) for diagnosing and monitoring preeclampsia

  This study will test whether three blood markers—the sFlt-1/PlGF ratio, soluble endoglin (sEng), and osteoprotegerin (OPG)—can help diagnose and track preeclampsia in pregnant women between 20 and 36 weeks of gestation.

  Recruiting University of Thi-Qar · Nasiriyah, Dhi Qar · NCT07349277

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.