CPAP in Preeclampsia

NCT02303834 | Terminated DMC

• 1 other identifier: HREC 14/092
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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. 1.Sleep study with fetal movement and HR monitor
2. 2.24 hour BP monitor
3. 3.CO2 monitor
4. 4.Sleep study with fetal movement and HR monitor
5. 5.24 hour BP monitor
6. 6.CO2 monitor

Conditions

Preeclampsia; Hypertension

Outcome Measures

Primary Outcomes (2)

• Maternal Blood Pressure

  Maternal blood pressure will be measured hourly for 48 hours during the 2 days of the study. This will be used to compare average nocturnal and daytime blood pressures between the first and 2nd (intervention) night in the 2 groups.

  2 days

• Fetal movements

  Fetal movements will be measured throughout the night for 2 consecutive nights (night 1 and night 2-intervention). This will be used to calculate average fetal movements per hour in each of the 2 groups.

  2 days

Study Arms (2)

Control

NO INTERVENTION

The control group will not be fitted with CPAP.

CPAP group

EXPERIMENTAL

The group will wear a CPAP device throughout the night. The mask fits comfortably over the nose and delivers a steady stream of air under slight pressure (auto-set).

Device: Continuous Positive Airway Pressure Ventilation (CPAP)

Interventions

Continuous Positive Airway Pressure Ventilation (CPAP) DEVICE

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

CPAP group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 24-37 weeks pregnant
• Singleton pregnancy
• Primiparous and primigravid
• Maternal age 18-45 years
• Diagnosis of preeclampsia by their treating specialist (SBP\>140/90 and proteinuria\>300mg in 24 hours)

You may not qualify if:

• A previous diagnosis of hypertension, cardiac, respiratory or renal disease.
• Any regular cardiac or respiratory medications (PRIOR to pregnancy and diagnosis of preeclampsia)
• Current smokers

Sponsors & Collaborators

• University of Sydney: lead
• Royal Prince Alfred Hospital, Sydney, Australia: collaborator

Study Sites (2)

Royal Hospital for Women

Sydney, New South Wales, 2031, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Colin Sullivan, MBBS phD

  University of Sydney

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)