Postpartum Hypertension, Tight vs Liberal Control Trial

Hypertension in the Obstetric Context Clinical Trial

Official title:

Postpartum Hypertension, Tight vs Liberal Control: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592783
• Other study ID #: 20200183
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: November 2, 2021

Study information

• Verified date: November 2021
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in the Obstetric Context

Intervention

Drug:
• Antihypertensive Agents
Antihypertensive medications will be initialed once BP is at predetermined threshold

Locations

Country	Name	City	State
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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