Postpartum Hypertension, Tight vs Liberal Control Trial

NCT04592783 | Completed DMC

• 1 other identifier: 20200183
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

Brief Summary

To determine if treatment of less severe hypertension in the postpartum period results in a lower frequency of maternal morbidity.

Conditions

Hypertension in the Obstetric Context

Keywords

Postpartum; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  Within 2 weeks of hospital discharge

Secondary Outcomes (4)

• Hospital readmission secondary to HTN or preeclampsia in the first 14 days postpartum

  2 weeks

• Persistence of hypertension (CHTN) at/beyond 14 days postpartum

  2 weeks

• Medication side effects (hypotension

  2 weeks

• Time to blood pressure control between different antihypertensive therapies

  2 weeks

Study Arms (2)

Tight Blood Pressure Control

EXPERIMENTAL

Antihypertensive medications will be initialed once BP is at or above 140/90 mmHg

Drug: Antihypertensive Agents

Liberal Blood Pressure Control

EXPERIMENTAL

Antihypertensive medications will be initialed once BP is at or above 150/95 mmHg

Drug: Antihypertensive Agents

Interventions

Antihypertensive Agents DRUG

Antihypertensive medications will be initialed once BP is at predetermined threshold

Liberal Blood Pressure Control; Tight Blood Pressure Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• MetroHealth Medical Center: collaborator

Study Sites (2)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Oluyemi Aderibigbe, MD

  UH, Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Multi-center Prospective Randomized Controlled Trial

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: October 19, 2020
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)