An observational study in Hypertensive Disorder of Pregnancy and Preeclampsia, sponsored by Ohio State University. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Ohio State University · Observational
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.
934 studies on the registry are indexed under Toxemia; 153 are open to participants now.
This study's planned enrollment of 68 is below the median of 144 across 458 observational studies indexed under Toxemia.
Browse Toxemia studies →Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
All new admissions to the Obstetrics (OB) antepartum unit with a diagnosis of preeclampsia with severe features will be reviewed and screened for eligibility.
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.
Exclusion criteria:
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).
Other: Treating BP acutely with intravenous or rapid acting oral medications
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.
Other: Treating BP acutely with intravenous or rapid acting oral medications
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.
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
Time frame: from randomization to delivery
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
Time frame: 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.
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
The indication for delivery will be categorized as the following non-reassuring fetal status, uncontrolled HTN, worsening symptoms/labs).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
The rate of birthweight \< 10th percentile for gestational age
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
The frequency of neonatal CPAP or intubation
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
The frequency of hypoglycemia (blood glucose \< 40 mg/dL, requiring IV treatment)
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
The frequency of bradycardia (heart rate \< 80/min in the first 48 hours)
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 179 non-industry observational studies under Toxemia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 13 months is below that.
Counting every sponsor, half of 204 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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