- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00546026
Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?
17. oktober 2007 oppdatert av: Mount Sinai Hospital, Canada
Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery due to medical problems such as diabetes or high blood pressure, are often very anxious during pregnancy, at least until they know they have passed the risk period of premature birth (after 8 months).
Anxiety itself can have a significant effect on the developing baby, on the newborn child and the mother-infant bonding process.
We will use a combination of pregnancy blood tests and an ultrasound assessment to check on placental function, since placental damage is the greatest cause of poor outcome.
Most women tested this way will have normal results, and so may feel reassured and do better in pregnancy than untested women.
The benefits may extend after birth to mother-infant bonding, breastfeeding success and a reduced risk of postnatal depression.
We will randomly select an equal number of women for testing and no testing (like tossing a coin, known as a randomized control trial) to be confident that any benefits observed are genuine.
The potential benefits of our research would be substantial for the mental health of many pregnant women, for their newborn and for their children as they grow up.
The tests are easy to do and would add very little in terms of a woman's and in terms of the total costs of prenatal care.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Women whose pregnancies are considered "high-risk" for medical reasons such (e.g.
preeclampsia, coagulation problems), often develop anxiety because of the possibility of a poor outcome.
Such anxiety can affect fetal development, neonatal wellbeing, child development and maternal mental health but it often goes unrecognized.
Also, women are often reluctant to use medications during pregnancy, especially if they perceive there may be the slightest risk to the fetus.
By assessing placental function at mid-pregnancy in this population, we can provide an accurate estimate of which women will develop severe complications later in the pregnancy.
We propose to perform a pilot randomized control trial formally incorporating placental assessment (Doppler ultrasound of the uterine artery and reassessment of diagnostic tests done earlier in pregnancy), with one group of "high-risk" women receiving the intervention (followed by feedback).
Measures of pregnancy outcome and anxiety will be compared with a control group receiving standard "high-risk" pregnancy care.
Levels of anxiety will be measured throughout the pregnancy using standardized scales.
We hypothesize that placental function testing will reduce the burden of anxiety for the majority of women who test negative in the placental assessment arm and that these women will have improved outcomes and measures of anxiety during and following pregnancy in comparison with untested women who perceive themselves to be at risk of pregnancy complications throughout pregnancy.
We also anticipate that the outcome of the pregnancy in women in the "tested" group will be more favorable (e.g.
reduced admissions of neonate to NICU).
Studietype
Intervensjonell
Registrering (Forventet)
160
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Patient of maternal/fetal medicine unit Mount Sinai Hospital
- Over 18 years of age
- Able to understand the nature of the study
- Able to provide consent to participation
- Singleton pregnancy
- Normal karyotype
- No major anatomical malformations at the 19 week ultrasound
- Fluent in English
Exclusion Criteria:
- Currently suffering from a major psychiatric illness or current use of psychotropic medications
- Current illegal substance or alcohol abuse
- Presence of a significant fetal structural abnormality on the 19 week ultrasound
- Abnormal karyotype
- Multifetal pregnancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Active group
Receive assessment of placental function
|
Formal assessment of placental function in mid-gestation by placental morphology and uterine artery Doppler at 20-22 weeks and re-interpretation of prior biochemical tests for Down's syndrome and spina bifida.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Primary outcome measure is STAI - The State Trait Anxiety Inventory
Tidsramme: Cross-sectional
|
Cross-sectional
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Women who undergo the placental function assessment will deliver at a later gestation age, have less complications and stillbirths than untested women. Neonates will have higher APGAR scores at 1 and 5 minutes and less likely to be admitted to the NICU.
Tidsramme: Cross-sectional
|
Cross-sectional
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eileen P. Sloan, MD, Mount Sinai Hospital, Canada
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Datoer for studieregistrering
Først innsendt
16. oktober 2007
Først innsendt som oppfylte QC-kriteriene
17. oktober 2007
Først lagt ut (Anslag)
18. oktober 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. oktober 2007
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. oktober 2007
Sist bekreftet
1. oktober 2007
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Sloan01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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