Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

Hypertension Clinical Trial

Official title:

Use of PAP in Women With Pre-eclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029691
• Other study ID #: F022873
• Secondary ID: 1K23HL095739-01
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: September 14, 2017
• Start date: May 2009
• Est. completion date: May 2015

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.

Description:

Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Women with preeclampsia who receive care at the University of Michigan Hospitals

• No current use of PAP therapy.

• Willing and able to provide informed consent.

Exclusion Criteria:

• Current PAP therapy

• Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).

• Cognitively impaired and unable to understand informed consent.

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• Positive Airway Pressure
Women will use positive airway pressure until delivery

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

O'Brien LM, Bullough AS, Chames MC, Shelgikar AV, Armitage R, Guilleminualt C, Sullivan CE, Johnson TR, Chervin RD. Hypertension, snoring, and obstructive sleep apnoea during pregnancy: a cohort study. BJOG. 2014 Dec;121(13):1685-93. doi: 10.1111/1471-052 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal Blood Pressure	measured by a 24 hour cuff, averaged across the night;	baseline and 1 week after PAP treatment.
Primary	Number of Participants With Worsening of Hypertension	This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.	1-6 months after enrollment.
Primary	Severity of Sleep Disordered Breathing	Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.	at baseline
Primary	Number of Participants With Sleep-disordered Breathing (SDB)	Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)	Baseline night 1
Secondary	Gestational Age at Delivery		At delivery (within 6 months of enrollment).
Secondary	Birth Weight		At delivery (within 6 months of enrollment)
Secondary	NICU Admission	Number of mothers who had one (or more) babies admitted to NICU	at delivery (within 6 months of enrollment)