RECRUITING

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

Conditions

Preeclampsia Gestational Hypertension Hypertensive Disorder of Pregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-14

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05676476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 49 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.) * Prenatal care, or another healthcare visit with a documented blood pressure, at less than 21 weeks gestation * Intact membranes	* 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

Inclusion Criteria

Exclusion 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.)
* Prenatal care, or another healthcare visit with a documented blood pressure, at less than 21 weeks gestation
* Intact membranes

* 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

Contacts and Locations

Study Contact

Rachel Sinkey, MD

CONTACT

205-934-5611

rsinkey@uabmc.edu

Alan Tita, MD

CONTACT

205-934-5611

atita@uabmc.edu

Principal Investigator

Rachel Sinkey, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Rachel Sinkey, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-14

Study Completion Date2027-06

Study Record Updates

Study Start Date2023-02-14

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Preeclampsia
Gestational Hypertension
Hypertensive Disorder of Pregnancy