Hypertensive Disorder of PregnancyNCT07894705
Blood Pressure Goal in Preterm Preeclampsia
An observational study of Hypertensive Disorder of Pregnancy and Preeclampsia, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to compare latency (prolongation of pregnancy from diagnosis till delivery) in patients with hypertensive disorders of pregnancy (HDP) with severe features < 34 weeks gestational age (GA), undergoing expectant management between tight and permissive blood pressure (BP) groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Preeclampsia
- What is being tested?
- Treating BP acutely with intravenous or rapid acting oral medications
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All new admissions to the Obstetrics (OB) antepartum unit with a diagnosis of preeclampsia with severe features will be reviewed and screened for eligibility.
Who may be able to join
- Pregnant individuals
- Age ≥ 18 years old
- HDP with severe features
- Planned inpatient admission for expectant management until delivery
- GA 24 - ≤ 32 weeks GA
- Singleton, non-anomalous fetus
- Anticipated delivery at the study institution
Who cannot join
- HDP with severe features > 32 weeks gestation at the time of admission
- Poorly controlled preexisting chronic hypertension on ≥2 oral antihypertensive medications
- Preexisting CKD with serum creatinine > 1.0
- Contraindications to expectant management of preeclampsia with severe features per ACOG (attached)
- Severe FGR (EFW < 3rd percentile) or FGR with umbilical artery doppler abnormalities (absent or reversed end diastolic flow) at the time of enrollment
- Multiple gestation
- Major fetal anomaly (attached)
- PPROM/active preterm labor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Jennifer Grasch, MD, 614-293-2222, Jennifer.Grasch@osumc.edu
About this study
Official title: Blood Pressure Goal in Preterm Preeclampsia (BLiPP)
The purpose of this study is to compare latency (prolongation of pregnancy from diagnosis till delivery) in patients with hypertensive disorders of pregnancy (HDP) with severe features < 34 weeks gestational age (GA), undergoing expectant management between tight and permissive blood pressure (BP) groups.
- Conditions
- Hypertensive Disorder of Pregnancy, Preeclampsia
- Being tested
- Treating BP acutely with intravenous or rapid acting oral medications
- Keywords
- Preeclampsia, Hypertensive Disorder of Pregnancy (HDP), preeclampsia with severe features, HDP with severe features, chronic hypertension, chronic hypertension with superimposed preeclampsia
- Medical subject headings
- Toxemia, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treating BP acutely with intravenous or rapid acting oral medicationsOther
In either group, sustained (persistent high blood pressures SBP ≥ 160 mm Hg and/or DBP ≥ 110 mmHg) are treated acutely with intravenous or rapid acting oral medications, per American College of Obstetricians \& Gynecologists (ACOG) recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Permissive BP group | Oral antihypertensive medications will be titrated with the goal of maintaining blood pressure (BP)< 160/110 mmHg. The care team will be instructed to increase antihypertensive medication dose or start a new medication (if maximum dose is attained on monotherapy), if one or more blood pressures are above goal (systolic blood pressure (SBP) ≥ 160 mmHg and diastolic blood pressure (DBP) ≥ 110 mm Hg). Receives: Other: Treating BP acutely with intravenous or rapid acting oral medications | |
| Tight BP group | Oral antihypertensive medications will be titrated with the goal of maintaining blood pressure (BP) < 140/90 mmHg. The care team will be instructed to increase antihypertensive medication dose or start a new medication (if maximum dose is attained on monotherapy), if ≥ 50% of BPs are above goal (systolic blood pressure (SBP) ≥ 140 mmHg and diastolic blood pressure (DBP) ≥ 90 mm Hg) in the prior 24 hours. Receives: Other: Treating BP acutely with intravenous or rapid acting oral medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean latency from diagnosis of hypertensive disorders of pregnancy (HDP) to delivery (continuous, mean with standard deviation)
The number of days from randomization to delivery will be analyzed as a continuous variable
Measured: from randomization to delivery
Secondary outcomes (37)
Blood pressure control (continuous, mean with standard deviation)
BP control will be analyzed as mean systolic and diastolic blood pressures; frequency of acute treatment (oral or IV) of severe range elevated BPs
Measured: from randomization to delivery
Serum Soluble fms-like tyrosine kinase 1 / placental growth factor (sFlt-1/PlGF) (log ratio)
Weekly serum sFlt-1/PlGF will be obtained from randomization until delivery. The clinical care team will be blinded to the results of this test as this is not part of our institutional protocol for inpatient management of HDP. The results will be analyzed at the conclusion of the study.
Measured: from randomization to delivery
The frequency of hemolysis, elevated liver enzymes, low platelets (HELLP)
Measured: from randomization through 6 weeks postpartum
Frequency of placental abruption
Measured: from randomization to delivery
Frequency of eclampsia
Measured: from randomization through 6 weeks postpartum
Frequency of stroke
Measured: from randomization through 6 weeks postpartum
Frequency of MI or angina
Measured: from randomization through 6 weeks postpartum
Frequency of heart failure
Measured: from randomization through 6 weeks postpartum
Frequency of intensive care unit (ICU) admission or intubation
Measured: from randomization through 6 weeks postpartum
Frequency of readmission within 42 days postpartum
Measured: from randomization through 6 weeks postpartum
Frequency of maternal death
Measured: from randomization through 6 weeks postpartum
Frequency of encephalopathy
Measured: from randomization through 6 weeks postpartum
Frequency of pulmonary edema
Measured: from randomization through 6 weeks postpartum
Frequency of Renal Failure
Measured: from randomization through 6 weeks postpartum
Indication for delivery
The indication for delivery will be categorized as the following non-reassuring fetal status, uncontrolled HTN, worsening symptoms/labs).
Measured: at delivery
Mode of delivery
The mode of delivery will be categorized as normal spontaneous vaginal delivery (NSVD), forceps assisted vaginal delivery (FAVD), vacuum assisted vaginal delivery (VAVD), C-section.
Measured: at delivery
Global health status (PRO) per the PRO Measurement Information System (PROMIS Global-10) (continuous, mean with standard deviation)
The PRO Measurement Information System (PROMIS Global-10) is a validated survey of patient-reported outcome measure to assess overall wellbeing. This survey will be administered from 4 to 6 weeks postpartum.
Measured: from 4 to 6 weeks postpartum
Birth experience satisfaction per Birth Satisfaction Scale- Revised (BSS-R (continuous, mean with standard deviation)
The Birth Satisfaction Survey- Revised (BSS-R) is a validated patient satisfaction survey describing L\&D birthing experiences. This survey will be administered at any time from delivery through 6 weeks postpartum.
Measured: from delivery to 6 weeks postpartum
Maternal infant bonding per maternal infant bonding scale (MIBS) (continuous, mean with standard deviation)
The maternal infant bonding scale (MIBS) is a validated is a validated survey of patient-reported outcome measure describing a mother's early emotional feelings and potential bonding challenges with her newborn. This survey will be administered from 4 to 6 weeks postpartum.
Measured: from 4 to 6 weeks postpartum
Gestational age at delivery (continuous, mean with standard deviation)
Measured: at delivery
Neonatal birthweight (continuous, mean with standard deviation)
Measured: at delivery
Frequency of small for gestational age (SGA)
The rate of birthweight < 10th percentile for gestational age
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Neonatal length of hospital stay (continuous, mean with standard deviation)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of 5 min Apgar score < 7
Measured: at the time of delivery
Frequency of need for neonatal respiratory support
The frequency of neonatal CPAP or intubation
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of hypoglycemia
The frequency of hypoglycemia (blood glucose < 40 mg/dL, requiring IV treatment)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of bradycardia
The frequency of bradycardia (heart rate < 80/min in the first 48 hours)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of respiratory distress syndrome (RDS)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of grade III-IV intraventricular hemorrhage (IVH)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of periventricular leukomalacia (PVL)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of stage 2/3 necrotizing enterocolitis (NEC)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of stage III or higher retinopathy of prematurity (ROP)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of suspected or proven neonatal sepsis
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of neonatal seizures
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of neonatal hyperbilirubinemia
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of transient tachypnea of the newborn (TTN)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of bronchopulmonary dysplasia (BPD)
Measured: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Grasch, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894705
- Sponsor's protocol ID
- STUDY20261628
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Goal in Preterm Preeclampsia (BLiPP)
- ClinicalTrials.gov ID
- NCT07894705
- Acronym / sponsor ID
- STUDY20261628
- Conditions
- Hypertensive Disorder of Pregnancy, Preeclampsia
- Keywords
- Preeclampsia, Hypertensive Disorder of Pregnancy (HDP), preeclampsia with severe features, HDP with severe features, chronic hypertension, chronic hypertension with superimposed preeclampsia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare latency (prolongation of pregnancy from diagnosis till delivery) in patients with hypertensive disorders of pregnancy (HDP) with severe features < 34 weeks gestational age (GA), undergoing expectant management between tight and permissive blood pressure (BP) groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permissive BP group | – | Other: Treating BP acutely with intravenous or rapid acting oral medicationsOral antihypertensive medications will be titrated with the goal of maintaining blood pressure (BP)< 160/110 mmHg. The care team will be instructed to increase antihypertensive medication dose or start a new medication (if maximum dose is attained on monotherapy), if one or more blood pressures are above goal (systolic blood pressure (SBP) ≥ 160 mmHg and diastolic blood pressure (DBP) ≥ 110 mm Hg). |
| Tight BP group | – | Other: Treating BP acutely with intravenous or rapid acting oral medicationsOral antihypertensive medications will be titrated with the goal of maintaining blood pressure (BP) < 140/90 mmHg. The care team will be instructed to increase antihypertensive medication dose or start a new medication (if maximum dose is attained on monotherapy), if ≥ 50% of BPs are above goal (systolic blood pressure (SBP) ≥ 140 mmHg and diastolic blood pressure (DBP) ≥ 90 mm Hg) in the prior 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All new admissions to the Obstetrics (OB) antepartum unit with a diagnosis of preeclampsia with severe features will be reviewed and screened for eligibility.
Key inclusion criteria (7 listed)
- Pregnant individuals
- Age ≥ 18 years old
- HDP with severe features
- Planned inpatient admission for expectant management until delivery
- GA 24 - ≤ 32 weeks GA
Key exclusion criteria (8 listed)
- HDP with severe features > 32 weeks gestation at the time of admission
- Poorly controlled preexisting chronic hypertension on ≥2 oral antihypertensive medications
- Preexisting CKD with serum creatinine > 1.0
- Contraindications to expectant management of preeclampsia with severe features per ACOG (attached)
- Severe FGR (EFW < 3rd percentile) or FGR with umbilical artery doppler abnormalities (absent or reversed end diastolic flow) at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treating BP acutely with intravenous or rapid acting oral medicationsIn either group, sustained (persistent high blood pressures SBP ≥ 160 mm Hg and/or DBP ≥ 110 mmHg) are treated acutely with intravenous or rapid acting oral medications, per American College of Obstetricians \& Gynecologists (ACOG) recommendations. | Other | Permissive BP group, Tight BP group |
Primary outcome
Mean latency from diagnosis of hypertensive disorders of pregnancy (HDP) to delivery (continuous, mean with standard deviation)
Time frame: from randomization to delivery
The number of days from randomization to delivery will be analyzed as a continuous variable
37 secondary outcomes
Blood pressure control (continuous, mean with standard deviation)
Time frame: from randomization to delivery
Serum Soluble fms-like tyrosine kinase 1 / placental growth factor (sFlt-1/PlGF) (log ratio)
Time frame: from randomization to delivery
The frequency of hemolysis, elevated liver enzymes, low platelets (HELLP)
Time frame: from randomization through 6 weeks postpartum
Frequency of placental abruption
Time frame: from randomization to delivery
Frequency of eclampsia
Time frame: from randomization through 6 weeks postpartum
Frequency of stroke
Time frame: from randomization through 6 weeks postpartum
Frequency of MI or angina
Time frame: from randomization through 6 weeks postpartum
Frequency of heart failure
Time frame: from randomization through 6 weeks postpartum
Frequency of intensive care unit (ICU) admission or intubation
Time frame: from randomization through 6 weeks postpartum
Frequency of readmission within 42 days postpartum
Time frame: from randomization through 6 weeks postpartum
Frequency of maternal death
Time frame: from randomization through 6 weeks postpartum
Frequency of encephalopathy
Time frame: from randomization through 6 weeks postpartum
Frequency of pulmonary edema
Time frame: from randomization through 6 weeks postpartum
Frequency of Renal Failure
Time frame: from randomization through 6 weeks postpartum
Indication for delivery
Time frame: at delivery
Mode of delivery
Time frame: at delivery
Global health status (PRO) per the PRO Measurement Information System (PROMIS Global-10) (continuous, mean with standard deviation)
Time frame: from 4 to 6 weeks postpartum
Birth experience satisfaction per Birth Satisfaction Scale- Revised (BSS-R (continuous, mean with standard deviation)
Time frame: from delivery to 6 weeks postpartum
Maternal infant bonding per maternal infant bonding scale (MIBS) (continuous, mean with standard deviation)
Time frame: from 4 to 6 weeks postpartum
Gestational age at delivery (continuous, mean with standard deviation)
Time frame: at delivery
Neonatal birthweight (continuous, mean with standard deviation)
Time frame: at delivery
Frequency of small for gestational age (SGA)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Neonatal length of hospital stay (continuous, mean with standard deviation)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of 5 min Apgar score < 7
Time frame: at the time of delivery
Frequency of need for neonatal respiratory support
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of hypoglycemia
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of bradycardia
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of respiratory distress syndrome (RDS)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of grade III-IV intraventricular hemorrhage (IVH)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of periventricular leukomalacia (PVL)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of stage 2/3 necrotizing enterocolitis (NEC)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of stage III or higher retinopathy of prematurity (ROP)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of suspected or proven neonatal sepsis
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of neonatal seizures
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of neonatal hyperbilirubinemia
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of transient tachypnea of the newborn (TTN)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Frequency of bronchopulmonary dysplasia (BPD)
Time frame: from date of delivery to hospital discharge or death, which ever comes first, will be assessed up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorder of Pregnancy and Preeclampsia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Grasch, MD (614-293-2222, Jennifer.Grasch@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean latency from diagnosis of hypertensive disorders of pregnancy (HDP) to delivery (continuous, mean with standard deviation) (time frame: from randomization to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.