Postpartum Hypertension, Tight vs Liberal Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypertension in the Obstetric Context
• Intervention / Treatment: Drug: Antihypertensive Agents

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 Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tight Blood Pressure Control; Antihypertensive medications will be initialed once BP is at or above 140/90 mmHg	Drug: Antihypertensive Agents; Antihypertensive medications will be initialed once BP is at predetermined threshold
Experimental: Liberal Blood Pressure Control; Antihypertensive medications will be initialed once BP is at or above 150/95 mmHg	Drug: Antihypertensive Agents; Antihypertensive medications will be initialed once BP is at predetermined threshold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital readmission secondary to HTN or preeclampsia in the first 14 days postpartum	Readmission	2 weeks
Persistence of hypertension (CHTN) at/beyond 14 days postpartum	Persistence of HTN	2 weeks
Medication side effects (hypotension	Side effects	2 weeks
Time to blood pressure control between different antihypertensive therapies	Time to BP control	2 weeks

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: MetroHealth Medical Center
• Investigators: Principal Investigator: Oluyemi Aderibigbe, MD, UH, Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Postpartum; Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Antihypertensive Agents
• Other Study ID Numbers: 20200183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No