Lowering blood pressure in pregnant women with hypertensive disorders to prolong pregnancy
The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
This study is testing if lowering blood pressure in pregnant women with high blood pressure can help them stay pregnant longer and improve outcomes for both mom and baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 14 Years to 49 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT05676476 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women between 23 and 35 weeks gestation with non-severe hypertensive disorders of pregnancy.
Not a fit: Patients with severe preeclampsia or those requiring immediate delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved pregnancy outcomes for women with hypertensive disorders, potentially reducing maternal and neonatal complications.
How similar studies have performed: Other studies have explored antihypertensive treatments in pregnancy, but this specific approach to prolong gestation in non-severe cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.