NCT02412696

Brief Summary

This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

5.2 years

First QC Date

January 21, 2015

Last Update Submit

November 20, 2024

Conditions

Obstructive Sleep ApneaPregnancyObesityPreeclampsiaSleep

Keywords

placental morphologyCPAPplacental secretory function

Outcome Measures

Primary Outcomes (2)

  • Alterations in circulating placenta-secreted markers.

    Placenta secreted markers that have been linked to preeclampsia as well as angiogenic and anti-angiogenic markers will be measured longitudinally during the course of pregnancy.

    up to 6 months

  • Changes in placental histopathology for markers of malperfusion and placental expression of markers

    Placental morphology and histopathology will be examined by 3 perinatal pathologists, blinded to each other's reading and to intervention arm. Immunohistochemistry will be used to examine placental expression of certain markers.

    Placenta collected at time of delivery

Secondary Outcomes (2)

  • Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements

    Prior to randomization, then at approximately 3 months, and 6 months later

  • Change in a composite of adverse pregnancy outcomes

    8 months, delivery and 2 weeks postpartum

Study Arms (2)

Positive Airway Pressure

ACTIVE COMPARATOR

Positive airway pressure and nasal dilator strips during sleep.

Device: Positive Airway PressureOther: Nasal Dilator Strips

Nasal Dilator Strips

PLACEBO COMPARATOR

Nasal dilator strips during sleep.

Other: Nasal Dilator Strips

Interventions

Positive Airway PressureDEVICE

Auto-titrating PAP + nasal dilator strips during sleep

Positive Airway Pressure
Nasal Dilator StripsOTHER

Nasal dilator strips

Nasal Dilator StripsPositive Airway Pressure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant snorers without obstructive sleep apnea, have a BMI \>30 kg/m2 at recruitment
  • \>18 years of age
  • \<13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification)
  • Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island
  • Ability to give informed consent.

You may not qualify if:

  • Inability to tolerate PAP therapy
  • Serious physical or mental illness or condition that would affect participation
  • Drowsy driving
  • Severe hypoxemia on sleep study
  • Advanced cardiac disease or arrhythmias that may benefit from PAP therapy
  • Chronic lung disease and / or respiratory failure.
  • Twin pregnancies
  • Fetuses with congenital anomalies
  • Severe hypertension at enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02904, United States

Location

Related Publications (2)

  • Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281.

    PMID: 34999843DERIVED

  • Facco F. Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy. Clin Obstet Gynecol. 2021 Mar 1;64(1):196-203. doi: 10.1097/GRF.0000000000000587.

    PMID: 33481418DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesityPre-Eclampsia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ghada Bourjeily, MD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 21, 2015

First Posted

April 9, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2020

Study Completion

May 1, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)