ClinicalTrials.gg
RecruitingNCT05676476AchieveUpdated Dec 12, 2025

The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.

An interventional study of Antihypertensive treatment in Preeclampsia, Gestational Hypertension and Hypertensive Disorder of Pregnancy, sponsored by University of Alabama at Birmingham. Recruiting at 2 sites in United States. Open to female participants aged 14 Years to 49 Years. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
14 Years to 49 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 228 studies in Pre-Eclampsia with a site in United States — 60 open to participants now, 76 under way, 6 of them phase 3. Pre-Eclampsia · United States.

Planned enrollment
54th of 159
132 · median 89
Started
2023
with 16 others
No phase
71 of 228
17 open now
Primary completion
2026-12
later than 22 of 75 live
Registered
158th of 228
by date
Lead sponsor
5 of 228
University of Alabama at Birmingham

Among the 228 studies in Pre-Eclampsia with a site in United States, this one is the 54th largest by planned enrollment of the 159 interventional ones, is one of 17 that started in 2023, is one of 71 with no phase, reaches primary completion later than 22 of the 75 other live ones, and was the 158th registered.

By phase

228 studies; the count open now beside each. This study's row is marked.

No phasethis study71 · 17 open
Observational69 · 14 open
Phase 431 · 11 open
Phase 121 · 6 open
Phase 218 · 7 open
Phase 312 · 4 open
Phase 1/23 · 1 open
Phase 2/33 · 0 open

By the year they started

First in 2000; this study’s year is marked. 17 started in 2023.

Size and results

Median enrollment 89 across the 159 interventional studies, 125 across the 69 observational. Of the 126 that completed or were terminated, 54 (43%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 228 studies in Pre-Eclampsia with a site in United States, or all of them as a file.
02

Study summary

The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure to less than 140/90 mmHg in women with hypertensive disorders of pregnancy will prolong pregnancy.

Read the detailed description

Hypertensive disorders of pregnancy, including gestational hypertension and preeclampsia, are characterized by new onset high blood pressure in pregnancy and constitute a major cause of maternal and perinatal morbidity and mortality; severe hypertension (blood pressure ≥160/110 mmHg) is a common trigger for antihypertensive treatment and preterm delivery. We propose a clinical trial that will test whether lowering the blood pressure in women with hypertensive disorders of pregnancy at \<36 weeks' gestation to \<140/90 mmHg will prolong pregnancy and, therefore, improve maternal and fetal/neonatal outcomes. Data generated in this study, along with knowledge and skills acquired by the candidate in the complementary career development plan, will facilitate an independent research career focused on hypertension and cardiovascular disease in pregnancy.

03

Conditions studied

  • Preeclampsia
  • Gestational Hypertension
  • Hypertensive Disorder of Pregnancy
04

Who can participate

Ages eligible
14 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • 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

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 /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
  • 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
Terms in these criteria, in plain language(2)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Intervention

    Antihypertensive treatment for a BP goal of less than 140/90 mmHg

    Drug: Antihypertensive treatment

  • No intervention
    Usual Care

    Antihypertensive treatment only if BP ≥ 160/110 mmHg

Interventions

  • DrugAntihypertensive treatment

    Antihypertensive treatment to goal of less than 140/90 mmHg

06

What researchers measure

Primary outcomes

  1. Mean number of days from randomization to delivery

    Duration of prolongation of pregnancy

    Time frame: From randomization to delivery, up to 14 weeks

Secondary outcomes

  1. Perinatal morbidity

    Composite of NICU admission ≥2 days, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, or fetal or newborn death within 6 weeks after birth; individual elements of the composite, the frequency of small for gestational age neonates, birthweight.

    Time frame: 6 weeks

  2. Neonatal healthcare utilization

    NICU and hospital length of stay

    Time frame: 6 weeks

  3. Maternal morbidity

    Composite of severe hypertension, pulmonary edema, heart failure, eclampsia, stroke, liver dysfunction, acute renal failure, thrombocytopenia, abruption, ICU admission, postpartum hospital readmission for hypertension management, or death within 6 weeks of delivery; individual elements of the composite.

    Time frame: From randomization to 6 weeks after delivery, up to 20 weeks

  4. Maternal healthcare utilization

    Antepartum and postpartum hospital length of stay, ICU admission, postpartum readmission.

    Time frame: From randomization to 6 weeks after delivery, up to 20 weeks

07

Study locations

2 of 2 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
    Recruiting
  • Oschner
    New Orleans, Louisiana 70115, United States
    Recruiting
08

References and documents

Publications

  • Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens. 2018 Mar;36(3):472-478. doi: 10.1097/HJH.0000000000001634. PubMed 29384983 ↗
  • Sinkey RG, Battarbee AN, Bello NA, Ives CW, Oparil S, Tita ATN. Prevention, Diagnosis, and Management of Hypertensive Disorders of Pregnancy: a Comparison of International Guidelines. Curr Hypertens Rep. 2020 Aug 27;22(9):66. doi: 10.1007/s11906-020-01082-w. PubMed 32852691 ↗
  • Ives CW, Sinkey R, Rajapreyar I, Tita ATN, Oparil S. Preeclampsia-Pathophysiology and Clinical Presentations: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Oct 6;76(14):1690-1702. doi: 10.1016/j.jacc.2020.08.014. PubMed 33004135 ↗
  • Battarbee AN, Sinkey RG, Harper LM, Oparil S, Tita ATN. Chronic hypertension in pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):532-541. doi: 10.1016/j.ajog.2019.11.1243. Epub 2019 Nov 9. PubMed 31715148 ↗
  • SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. PubMed 26551272 ↗
  • Bello NA, Woolley JJ, Cleary KL, Falzon L, Alpert BS, Oparil S, Cutter G, Wapner R, Muntner P, Tita AT, Shimbo D. Accuracy of Blood Pressure Measurement Devices in Pregnancy: A Systematic Review of Validation Studies. Hypertension. 2018 Feb;71(2):326-335. doi: 10.1161/HYPERTENSIONAHA.117.10295. Epub 2017 Dec 11. PubMed 29229741 ↗
  • Sinkey RG, Oparil S. Lower Blood Pressure Thresholds Raise the Bar in Pregnancy. Circ Res. 2019 Jul 5;125(2):195-197. doi: 10.1161/CIRCRESAHA.119.315384. Epub 2019 Jul 3. No abstract available. PubMed 31268860 ↗
  • ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. PubMed 30575675 ↗
  • Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Iams JD, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012 Jun;119(6):1234-42. doi: 10.1097/AOG.0b013e3182571669. PubMed 22617589 ↗
  • Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Grobman WA, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). The utility of uterine artery Doppler velocimetry in prediction of preeclampsia in a low-risk population. Obstet Gynecol. 2012 Oct;120(4):815-22. doi: 10.1097/AOG.0b013e31826af7fb. PubMed 22996099 ↗
  • Petersen EE, Davis NL, Goodman D, Cox S, Syverson C, Seed K, Shapiro-Mendoza C, Callaghan WM, Barfield W. Racial/Ethnic Disparities in Pregnancy-Related Deaths - United States, 2007-2016. MMWR Morb Mortal Wkly Rep. 2019 Sep 6;68(35):762-765. doi: 10.15585/mmwr.mm6835a3. PubMed 31487273 ↗
  • Tita AT, Szychowski JM, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson K, Haas DM, Plante L, Metz T, Casey B, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su E, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Oparil S, Cutter GR, Andrews WW; Chronic Hypertension and Pregnancy (CHAP) Trial Consortium. Treatment for Mild Chronic Hypertension during Pregnancy. N Engl J Med. 2022 May 12;386(19):1781-1792. doi: 10.1056/NEJMoa2201295. Epub 2022 Apr 2. PubMed 35363951 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Dec 2026, 46 months after the start.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 46 months is above that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

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

Registered
Jan 3, 2023
First posted
Jan 9, 2023
StartActual
Feb 14, 2023
Primary completionEst.
Dec 2026
CompletionEst.
Jun 2027
Last update
Dec 12, 2025
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 Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05676476
Responsible party
Rachel Sinkey (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 9, 2023
Start date
Feb 14, 2023
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Dec 12, 2025

Study contacts

Rachel Sinkey, MD
Contact
rsinkey@uabmc.edu
205-934-5611
Alan Tita, MD
Contact
atita@uabmc.edu
205-934-5611
Rachel Sinkey, MD
principal investigator · University of Alabama at Birmingham

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion