NCT02649933

Brief Summary

To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

December 17, 2015

Last Update Submit

May 11, 2016

Conditions

PregnancySleep Apnea SyndromeObstructive Sleep Apnea

Keywords

pregnancyobstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • prevalence of sleep apnea syndrome (OSA) in obese pregnant women

    Positive OSA on Watch Pat 200 must be confirmed by polysomnography

    1 month

Secondary Outcomes (1)

  • composite score assessing pregnancy course and materno-foetal complications

    6 months

Study Arms (1)

Watch PAt 200

obese pregnant women, pregnancy between 12 and 15 weeks

Device: Watch PAT 200

Interventions

Watch PAT 200DEVICE

screening of OSA with Watch PAT 200

Watch PAt 200

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women, 12-15weeks of pregnancy, obese (body mass index\>30)

You may qualify if:

  • pregnant women
  • weeks of pregnancy
  • obese (body mass index\>30)

You may not qualify if:

  • known sleep apnea syndrome
  • mental illness, deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU St Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chef de clinique service de pneumologie

Study Record Dates

First Submitted

December 17, 2015

First Posted

January 8, 2016

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)