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CPAP in Preeclampsia

NCT02303834 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-05-03

No results posted yet for this study

Summary

Study design:

Single blinded randomised control trial

Planned sample size:

30 (women randomized 2:1 to receive either CPAP or no CPAP)

Objectives:

Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia.

Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR monitors.

Study Procedure:

Participants will be recruited from the antenatal ward or high-risk antenatal clinic. Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night, following an initial baseline overnight sleep study.

Baseline- Night 1

1. Sleep study with fetal movement and HR monitor
2. 24 hour BP monitor
3. CO2 monitor

Intervention- Night 2 (Nasal CPAP device or no CPAP)

1. Sleep study with fetal movement and HR monitor
2. 24 hour BP monitor
3. CO2 monitor

Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participant's personal health, their child's birth details and health.

Conditions

Interventions

DEVICE

Continuous Positive Airway Pressure Ventilation (CPAP)

A mask worn over the nose that delivers air under slight pressure.

Sponsors & Collaborators

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Colin Sullivan, MBBS phD · University of Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303834 on ClinicalTrials.gov