- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01022619
The Association Between High Risk Pregnancy and Sleep-disordered Breathing
30. november 2009 opdateret af: Assaf-Harofeh Medical Center
The aim of the present study is to establish, using polysomnographic criteria and prospective nature, whether sleep apnea in pregnancy is more prevalent in women with high risk pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to determine the effect of sleep disordered breathing in pregnancy on fetal outcome.
The investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with high risk pregnancy compared to those with uncomplicated pregnancy.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Over the last decade, the association between sleep disordered breathing and pregnancy outcome has been described primarily in case reports.
Although recently, larger studies describing adverse pregnancy outcomes in women with sleep disordered breathing has begun to emerge, these studies often lack polysomnographic data and the true prevalence of sleep disordered breathing in pregnancy is not known.
We intend to recruit 100 women at the third trimester of pregnancy, who are admitted to the high risk pregnancy unit with pre-eclampsia, gestational diabetes, or premature labor.
An additional group of 50 women at the third trimester of an uncomplicated pregnancy will be recruited.
All women will fill questionnaires regarding the pregnancy and their sleep and will undergo an overnight sleep study.
Women will then be followed until birth.
Pregnancy complication, birth and perinatal course will be recorded.
Cord blood will be collected from all infants and evaluated for inflammatory cytokines, reactive oxygen species and growth factors.
Infants will then be followed for 1 year.
Their growth, development and intercurrent illnesses will be recorded.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
150
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Kfar-Saba, Israel, 44281
- Meir Hospital
-
Zerifin, Israel, 70300
- Asaf Harofeh Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 39 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course
Beskrivelse
Inclusion Criteria:
- Age 19 - 39 years
- Over 26 weeks of gestation
One of the following:
- Pre-eclampsia defined as systolic blood pressure > 140 or diastolic blood pressure > 90 and associated proteinuria > 300 mg / 24 h urine collection.
- Gestational diabetes requiring insulin treatment
- Premature contractions with associated cervical dilation or effacement
- Uncomplicated pregnancy
Exclusion Criteria:
- Chronic maternal disease
- Alcohol consumption during pregnancy
- Illicit drug abuse at any time in life
- Fetal abnormalities on obstetric ultrasound
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Premature labor
Women at the third trimester of pregnancy with premature contractions and cervical dilation of effacement
|
Control
Women at the third trimester of pregnancy with uncomplicated pregnancy
|
Pre-eclampsia
Women at the third trimester with pre-eclampsia
|
Gestational diabets
Women at the third trimester of pregnancy with gestational diabetes requiring insulin
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
apnea-hypopnea index
Tidsramme: At time of assessment
|
At time of assessment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
birth weight, apgar score
Tidsramme: at birth
|
at birth
|
inflammatory markers in cord blood
Tidsramme: at birth
|
at birth
|
growth and development during the 1st year of life
Tidsramme: at age 1 year
|
at age 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Isaac Shpirer, MD, Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Forventet)
1. januar 2012
Datoer for studieregistrering
Først indsendt
26. november 2009
Først indsendt, der opfyldte QC-kriterier
30. november 2009
Først opslået (Skøn)
1. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. december 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2009
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Apnø
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Sygdomme i det endokrine system
- Diabetes mellitus
- Graviditetskomplikationer
- Obstetriske arbejdskomplikationer
- Hypertension, graviditetsinduceret
- Søvnapnø syndromer
- Præeklampsi
- Obstetrisk arbejde, for tidligt
- Diabetes, svangerskabssyge
Andre undersøgelses-id-numre
- 61/09
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .