Hypertension in the Obstetric ContextNCT04592783
Postpartum Hypertension, Tight vs Liberal Control Trial
A study testing Antihypertensive Agents in people with Hypertension in the Obstetric Context, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
To determine if treatment of less severe hypertension in the postpartum period results in a lower frequency of maternal morbidity. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in the Obstetric Context
- What is being tested?
- Antihypertensive Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2020to 2 Nov 2021
- Phase
- Interventional
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum women aged 18-55 during delivery hospitalization.
- Diagnosis of gestational hypertension, preeclampsia without severe features, or chronic hypertension without requiring antihypertensive therapy who have Blood Pressure at/above 140/90 mmHg on 2 or more occasions more than 4 hours apart and do NOT meet criteria for preeclampsia with severe features and have not received any antihypertensive therapy during their hospitalization
Who cannot join
- History of chronic hypertension requiring antihypertensive therapy prior to or during pregnancy.
- Diagnosis and/or treatment of preeclampsia with severe features before trial enrollment
- Postpartum patients enrolled in another antihypertensive study (e.g CHAPS)
- Medical comorbidities including: Active connective tissue disease, chronic renal insufficiency, known cardiac disease or cerebrovascular disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Metrohealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: Postpartum Hypertension, Tight vs Liberal Control: A Randomized Controlled Trial
To determine if treatment of less severe hypertension in the postpartum period results in a lower frequency of maternal morbidity.
Read the detailed description
Patients with postpartum hypertension are at risk of developing preeclampsia, eclampsia, and severe maternal morbidity. About one-third of eclampsia occurs in the postpartum period. Fifty percent of intra-cerebral hemorrhages occurring in association with preeclampsia occur in the postpartum period. In addition to the maternal morbidity that may arise from severe hypertension in the postpartum period, additional consequences of inadequate blood pressure control include maternal readmission, its associated costs to the healthcare system, and its destabilizing effect on a new family. Furthermore, pregnant women with hypertensive disorders in pregnancy are at an increased risk of persistent postpartum hypertension and metabolic syndrome within the first year after delivery. Therefore, untreated postpartum hypertension may significantly impact on long term cardiometabolic outcomes for reproductive aged-women.
Evidence-based guidance is lacking on the blood pressure threshold to initiate antihypertensive therapy in the postpartum period. Current clinical practice is extrapolated from management during pregnancy and no prior trials have been conducted on the threshold for initiation of antihypertensive medication in the postpartum period. A systematic review in 2017 concluded "there is a lack of good quality evidence for postpartum management, emphasizing the need for further RCTs directly comparing different antihypertensive agents, BP threshold for medication adjustment and different models of care, with outcome measures other than postnatal readmissions" Based on low quality evidence/expert opinion ACOG and the National Institute of Heath and Care Excellence (NICE) in the UK both recommend initiating antihypertensive at a BP threshold of 150/100mmhg. NICE further recommends keeping BP lower than 140/90mmHg in patients with chronic hypertension and reducing antihypertensive medications when BP is less than 130/80mmHg in this population. ACOG does not mention at which BP threshold to reduce medications or when to stop antihypertensive therapy. There are obvious gaps in knowledge as stated in the systematic review. Therefore, our objective is to provide evidence to inform best practices with regards to the management of hypertension in the postpartum period through this randomized controlled trial.
- Conditions
- Hypertension in the Obstetric Context
- Being tested
- Antihypertensive Agents
- Keywords
- Postpartum; Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive AgentsDrug
Antihypertensive medications will be initialed once BP is at predetermined threshold
| Study group | Role | What they receive |
|---|---|---|
| Tight Blood Pressure Control | Experimental | Antihypertensive medications will be initialed once BP is at or above 140/90 mmHg Receives: Drug: Antihypertensive Agents |
| Liberal Blood Pressure Control | Experimental | Antihypertensive medications will be initialed once BP is at or above 150/95 mmHg Receives: Drug: Antihypertensive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of the following: Development of severe HTN or preeclampsia with severe features, hospitalization > 4 days, use of a second antihypertensive agent, adverse maternal outcomes and emergent treatment of severe HTN.
Composite outcomes
Measured: Within 2 weeks of hospital discharge
Secondary outcomes (4)
Hospital readmission secondary to HTN or preeclampsia in the first 14 days postpartum
Readmission
Measured: 2 weeks
Persistence of hypertension (CHTN) at/beyond 14 days postpartum
Persistence of HTN
Measured: 2 weeks
Medication side effects (hypotension
Side effects
Measured: 2 weeks
Time to blood pressure control between different antihypertensive therapies
Time to BP control
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Oct 2020
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in the Obstetric ContextStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center Prospective Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MetroHealth Medical Center
- Responsible party
- Principal investigator, Oluyemi Aderibigbe, University Hospitals Cleveland Medical Center
- Investigators
- Oluyemi Aderibigbe, MD, Principal investigator, UH, Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592783
- Sponsor's protocol ID
- 20200183
- Status last verified
- Nov 2021
- First submitted
- 14 Oct 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Hypertension, Tight vs Liberal Control: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04592783
- Acronym / sponsor ID
- 20200183
- Conditions
- Hypertension in the Obstetric Context
- Keywords
- Postpartum; Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- MetroHealth Medical Center
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 19 Oct 2020 (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.
To determine if treatment of less severe hypertension in the postpartum period results in a lower frequency of maternal morbidity.
Detailed description
Patients with postpartum hypertension are at risk of developing preeclampsia, eclampsia, and severe maternal morbidity. About one-third of eclampsia occurs in the postpartum period. Fifty percent of intra-cerebral hemorrhages occurring in association with preeclampsia occur in the postpartum period. In addition to the maternal morbidity that may arise from severe hypertension in the postpartum period, additional consequences of inadequate blood pressure control include maternal readmission, its associated costs to the healthcare system, and its destabilizing effect on a new family. Furthermore, pregnant women with hypertensive disorders in pregnancy are at an increased risk of persistent postpartum hypertension and metabolic syndrome within the first year after delivery. Therefore, untreated postpartum hypertension may significantly impact on long term cardiometabolic outcomes for reproductive aged-women.
Evidence-based guidance is lacking on the blood pressure threshold to initiate antihypertensive therapy in the postpartum period. Current clinical practice is extrapolated from management during pregnancy and no prior trials have been conducted on the threshold for initiation of antihypertensive medication in the postpartum period. A systematic review in 2017 concluded "there is a lack of good quality evidence for postpartum management, emphasizing the need for further RCTs directly comparing different antihypertensive agents, BP threshold for medication adjustment and different models of care, with outcome measures other than postnatal readmissions" Based on low quality evidence/expert opinion ACOG and the National Institute of Heath and Care Excellence (NICE) in the UK both recommend initiating antihypertensive at a BP threshold of 150/100mmhg. NICE further recommends keeping BP lower than 140/90mmHg in patients with chronic hypertension and reducing antihypertensive medications when BP is less than 130/80mmHg in this population. ACOG does not mention at which BP threshold to reduce medications or when to stop antihypertensive therapy. There are obvious gaps in knowledge as stated in the systematic review. Therefore, our objective is to provide evidence to inform best practices with regards to the management of hypertension in the postpartum period through this randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center Prospective Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Tight Blood Pressure Control | Experimental | Drug: Antihypertensive AgentsAntihypertensive medications will be initialed once BP is at or above 140/90 mmHg |
| Liberal Blood Pressure Control | Experimental | Drug: Antihypertensive AgentsAntihypertensive medications will be initialed once BP is at or above 150/95 mmHg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Postpartum women aged 18-55 during delivery hospitalization.
- Diagnosis of gestational hypertension, preeclampsia without severe features, or chronic hypertension without requiring antihypertensive therapy who have Blood Pressure at/above 140/90 mmHg on 2 or more occasions more than 4 hours apart and do NOT meet criteria for preeclampsia with severe features and have not received any antihypertensive therapy during their hospitalization
Key exclusion criteria (4 listed)
- History of chronic hypertension requiring antihypertensive therapy prior to or during pregnancy.
- Diagnosis and/or treatment of preeclampsia with severe features before trial enrollment
- Postpartum patients enrolled in another antihypertensive study (e.g CHAPS)
- Medical comorbidities including: Active connective tissue disease, chronic renal insufficiency, known cardiac disease or cerebrovascular disease.
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 |
|---|---|---|
| Antihypertensive AgentsAntihypertensive medications will be initialed once BP is at predetermined threshold | Drug | Liberal Blood Pressure Control, Tight Blood Pressure Control |
Primary outcome
A composite of the following: Development of severe HTN or preeclampsia with severe features, hospitalization > 4 days, use of a second antihypertensive agent, adverse maternal outcomes and emergent treatment of severe HTN.
Time frame: Within 2 weeks of hospital discharge
Composite outcomes
4 secondary outcomes
Hospital readmission secondary to HTN or preeclampsia in the first 14 days postpartum
Time frame: 2 weeks
Persistence of hypertension (CHTN) at/beyond 14 days postpartum
Time frame: 2 weeks
Medication side effects (hypotension
Time frame: 2 weeks
Time to blood pressure control between different antihypertensive therapies
Time frame: 2 weeks
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 9 Nov 2021.
- Individual participant dataSharing planned: No
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.
Oluyemi Aderibigbe, MD principal investigator
UH, Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antihypertensive Agents in people with Hypertension in the Obstetric Context, run by University Hospitals Cleveland Medical Center at 2 sites 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 2 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
A composite of the following: Development of severe HTN or preeclampsia with severe features, hospitalization > 4 days, use of a second antihypertensive agent, adverse maternal outcomes and emergent treatment of severe HTN. (time frame: Within 2 weeks of hospital discharge). 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 9 Nov 2021.