Optimal Blood Pressure Treatment Thresholds Postpartum | NCT06069102

NCT06069102

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care Group	Active Comparator	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.	Drug: Usual care
Intervention (Tight Blood Pressure Control) Group	Experimental	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.	Drug: Tight blood pressure control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Usual care	Drug	The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Participants Eligible, Enrolled and Retained (Feasibility)	To determine if a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home blood pressure monitoring) vs. standard of care (<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.	Baseline to approximately 6 months postpartum, a total of 6 months postpartum

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Anti-hypertensive Medication Use	Number of participants with anti-hypertensive medication use	6 months postpartum
Anti-hypertensive Medication Use	Anti-hypertensive medication use

Other Outcomes

Measure	Description	Time Frame
Interval Participant Retention	Number of participants retained to 6 weeks postpartum	6 weeks postpartum
Participant Retention	Retention of participants to 6 months postpartum

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Alisse K Hauspurg, MD	UPMC Magee Women's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Magee-Womens Hospital		Pittsburgh	Pennsylvania	15213	United States

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 10, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Arm/Group Information

ID	Title	Description
BG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
BG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00031 BG00130 BG00261

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00030.0± 5.6 BG00130.1± 4.8 BG00230.1± 5.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00031 BG00130 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00031 BG00130 BG002

Systolic blood pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG000129.6± 9.7 BG001124.1± 12.3 BG002

Diastolic blood pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG00086.4± 8.5 BG00183.2± 10.1 BG002

Mean arterial pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG000100.8± 8.1 BG00196.8± 10.0 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent of Participants Eligible, Enrolled and Retained (Feasibility)

To determine if a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home blood pressure monitoring) vs. standard of care (<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.

Number of participants approached for enrollment

Posted

Count of Participants

Participants

Baseline to approximately 6 months postpartum, a total of 6 months postpartum

ID	Title	Description
OG000	Enrollment	Proportion of individuals enrolled compared to number approached.

Units	Counts
Participants	OG000143

Title

Denominators

Categories

Title	Measurements
	OG00061

Secondary

Number of Participants With Anti-hypertensive Medication Use

Number of participants with anti-hypertensive medication use

Posted

Count of Participants

Participants

6 months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Secondary

Anti-hypertensive Medication Use

Anti-hypertensive medication use

Posted

Count of Participants

Participants

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Secondary

Mean Arterial Pressure (Efficacy)

Mean arterial pressure (systolic BP + 2*diastolic BP / 3)

Posted

Mean

Standard Deviation

mmHg

6 months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Secondary

Mean Arterial Pressure

Mean arterial pressure (systolic BP + 2*diastolic BP / 3)

Posted

Mean

Standard Deviation

mmHg

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Secondary

Systolic Blood Pressure

Mean systolic blood pressure

Posted

Mean

Standard Deviation

mmHg

6 months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Secondary

Diastolic Blood Pressure

Mean diastolic blood pressure

Posted

Mean

Standard Deviation

mmHg

6 months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Secondary

Diastolic Blood Pressure

Mean diastolic blood pressure

Posted

Mean

Standard Deviation

mmHg

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Secondary

Change in MAP

Change in mean arterial pressure (systolic BP + 2*diastolic BP / 3) from baseline

Posted

Mean

Standard Deviation

mmHg

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Secondary

Change in Systolic BP

Change in systolic BP from baseline

Posted

Mean

Standard Deviation

mmHg

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Secondary

Change in Diastolic BP

Change in diastolic BP from baseline

Posted

Mean

Standard Deviation

mmHg

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Hospital Readmissions

Postpartum hospital readmissions

Posted

Count of Participants

Participants

Six months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Secondary

Number of Participants With ER Visits

Emergency room visits

Posted

Count of Participants

Participants

Six months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants	OG000

Other Pre-specified

Interval Participant Retention

Number of participants retained to 6 weeks postpartum

Posted

Count of Participants

Participants

6 weeks postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Other Pre-specified

Participant Retention

Retention of participants to 6 months postpartum

Posted

Count of Participants

Participants

6 months postpartum

ID	Title	Description
OG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
OG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Usual Care Group	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Usual care: The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.	0	31	0	31	0	31
EG001	Intervention (Tight Blood Pressure Control) Group	BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Tight blood pressure control: The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.	0	30	0	30	0	30

ID	Term
D014115	Toxemia
D011225	Pre-Eclampsia
D006973	Hypertension
D004461	Eclampsia
D046110	Hypertension, Pregnancy-Induced
D002318	Cardiovascular Diseases
D011248	Pregnancy Complications
D014652	Vascular Diseases

ID	Term
D007239	Infections
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases