A pilot study to assess the impact of obstructive sleep apnea (OSA) and treatment with continuous positive airway pressure (CPAP) therapy on maternal blood pressure and placental blood flow in high risk obstetric patients

Not Applicable

Recruiting

• Conditions: Obstructive sleep apnea; Maternal hypertension; Respiratory - Sleep apnoea; Reproductive Health and Childbirth - Antenatal care; Cardiovascular - Hypertension

• Registration Number: ACTRN12618001963213
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-05
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Early pregnancy BMI of 35 kg/m2 or more
Gestational age less than 28 weeks
Ability to given informed consent

Exclusion Criteria

Lack of regular attendance at clinic appointments
Illicit or intravenous drug use
Current cigarette smoking
Known diagnosis of OSA already established on CPAP therapy
Type 1 diabetes mellitus
Pulmonary hypertension
cardiomyopathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal blood pressure control as measured by manual sphygmomanometer/digital blood pressure cuff at clinic visits and recorded in the patient's medical notes.[For the duration of pregnancy, recorded at every pregnancy clinic appointment (20 weeks, 28 weeks, 32 weeks, 38 weeks, delivery and at any additional outpatient clinic appointments during pregnancy)]

Secondary Outcome Measures

Name	Time	Method
Maternal quality of life as assessed by AQOL-8 and the sleep apnea specific version SAQLI[At enrollment prior to 28, at 32 weeks gestational age and 3 months post partum];Placental vascular health (as measured by arterial doppler)[28, 32 and 36 weeks gestation age];Placental vascular health (assessed following delivery by histopathology)[at delivery ];Pregnancy complications as documented in pregnancy health record, via patient report or from medical records including: gestational diabetes, gestational hypertension, preeclampsia, preterm delivery, emergency ceasarean section, admission to ICCU, neonatal ICCU admission, APGAR scores at birth, neonatal birth weight[Until delivery];Persistence of obstructive sleep apnea as assessed by a repeat diagnostic polysomnogram[6 months post partum]