Maternal HypertensionNCT05881252
Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
An observational study of Maternal Hypertension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Hypertension
- What is being tested?
- Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension and Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension
- Type of treatment
- Surgery or procedure
- How many people
- 1,003 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2023to 4 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) in Houston, Texas and with blood pressure with >= 160/110 mmHg
Who may be able to join
- any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with >= 160/110 mmHg
Who cannot join
- Active seizure, stroke, Congestive Heart Failure (CHF)/pulmonary edema, acute kidney injury (AKI), or myocardial infarction (MI)
- A history of stroke, CHF, chronic kidney disease (CKD), MI
- Have Hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome or thrombocytopenia (platelets < 100×10^9/L)
- Persistent neurologic symptoms including headache >8/10 one hour after analgesic or blurry vision/loss of vision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
The purpose of this study is observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. Outcomes will be observed for 10 months under the current (traditional) clinical blood pressure threshold for acute treatment of hypertension, which is >= 160 millimeters of mercury (mmHg) systolic blood pressure (SBP). This will be followed by one month of education about rationale for the new SBP threshold of >= 180 mmHg and change of clinical guidelines. Then, there will be 10 months of observation after adopting the updated clinical threshold for acute antihypertensive treatment (>= 180 SBP).
- Conditions
- Maternal Hypertension
- Being tested
- Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension, Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertensionProcedure or surgery
Patients are treated for hypertension if SBP >= 160 mmHg.
Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertensionProcedure or surgery
Patients are treated for hypertension if SBP >= 180 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension | Not described Receives: Procedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension | |
| Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension | Not described Receives: Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or or Myocardial Ischemia.
The primary outcome is a composite outcome, and will be reported as number of patients who have Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or Myocardial Ischemia.
Measured: during the time of delivery hospitalization (about 2 days to 3 months)
Secondary outcomes (6)
Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery
Measured: at the time of delivery
Number of patients with Apgar score < 7 at 5 min
The Apgar score indicates the status of the newborn infant immediately after birth. Apgar score ranges from 0-10, with a higher score indicating a better outcome.
Measured: 5 minutes after birth
Number of patients with eclampsia
Measured: during the time of delivery hospitalization (about 2 days to 3 months)
Number of patients with placental abruption
Measured: during the time of delivery hospitalization (about 2 days to 3 months)
Number of patients with posterior reversible encephalopathy syndrome (PRES)
Measured: during the time of delivery hospitalization (about 2 days to 3 months)
Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome
Measured: during the time of delivery hospitalization (about 2 days to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start11 May 2023
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Cagino, The University of Texas Health Science Center, Houston
- Investigators
- Kristen Cagino, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881252
- Sponsor's protocol ID
- HSC-MS-23-0241
- Status last verified
- Jul 2025
- First submitted
- 18 May 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
- ClinicalTrials.gov ID
- NCT05881252
- Acronym / sponsor ID
- HSC-MS-23-0241
- Conditions
- Maternal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 31 May 2023 (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 observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. Outcomes will be observed for 10 months under the current (traditional) clinical blood pressure threshold for acute treatment of hypertension, which is >= 160 millimeters of mercury (mmHg) systolic blood pressure (SBP). This will be followed by one month of education about rationale for the new SBP threshold of >= 180 mmHg and change of clinical guidelines. Then, there will be 10 months of observation after adopting the updated clinical threshold for acute antihypertensive treatment (>= 180 SBP).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension | – | Procedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension |
| Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension | – | Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) in Houston, Texas and with blood pressure with >= 160/110 mmHg
Key inclusion criteria (1 listed)
- any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with >= 160/110 mmHg
Key exclusion criteria (4 listed)
- Active seizure, stroke, Congestive Heart Failure (CHF)/pulmonary edema, acute kidney injury (AKI), or myocardial infarction (MI)
- A history of stroke, CHF, chronic kidney disease (CKD), MI
- Have Hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome or thrombocytopenia (platelets < 100×10^9/L)
- Persistent neurologic symptoms including headache >8/10 one hour after analgesic or blurry vision/loss of vision
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 |
|---|---|---|
| Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertensionPatients are treated for hypertension if SBP >= 160 mmHg. | Procedure or surgery | Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension |
| Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertensionPatients are treated for hypertension if SBP >= 180 mmHg. | Procedure or surgery | Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension |
Primary outcome
Number of patients with Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or or Myocardial Ischemia.
Time frame: during the time of delivery hospitalization (about 2 days to 3 months)
The primary outcome is a composite outcome, and will be reported as number of patients who have Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or Myocardial Ischemia.
6 secondary outcomes
Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery
Time frame: at the time of delivery
Number of patients with Apgar score < 7 at 5 min
Time frame: 5 minutes after birth
Number of patients with eclampsia
Time frame: during the time of delivery hospitalization (about 2 days to 3 months)
Number of patients with placental abruption
Time frame: during the time of delivery hospitalization (about 2 days to 3 months)
Number of patients with posterior reversible encephalopathy syndrome (PRES)
Time frame: during the time of delivery hospitalization (about 2 days to 3 months)
Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome
Time frame: during the time of delivery hospitalization (about 2 days to 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Preeclampsia
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Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
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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. This study is not recruiting at the moment.
Kristen Cagino, MD principal investigator
The University of Texas Health Science Center, Houston
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 Maternal Hypertension, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or or Myocardial Ischemia. (time frame: during the time of delivery hospitalization (about 2 days to 3 months)). 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 28 Jul 2025.