Philadelphia Preterm Prevention Project (PPP)
Philadelphia Collaborative Preterm Prevention Project
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a randomized clinical trial in which all Philadelphia resident women experiencing a pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be approached at the time of the postpartum hospital stay. Consenting women will be randomized into a usual care group or an interconceptional intervention targeting five risk conditions, all of which increase systemic inflammation. Our primary objective in this study is to assess the efficacy of our interconceptional intervention on the rate of repeat PTB.
Participants will be randomized into one of two groups: usual care of interconceptional intervention. Those who are randomized into the interconceptional intervention group will be targeted for five risk conditions, including smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate BMI. It is hoped that by reducing these seemingly disparate yet well-known risk conditions, we can reduce PTB and the subsequent race/ethnic disparities.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- delivery of live born infant at <34 weeks of gestation in one of 18 Philadelphia area hospitals
- English or Spanish speaking
- Philadelphia residency
- not receiving operative sterilization before discharge from the hospital
Exclusion Criteria:
- N/A
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
After consent, subjects will be assigned to either a usual care group (no intervention) or an intervention group (targeted interconceptional interventions).
|
Subjects will be randomized into either usual care or interconceptional intervention groups.
If the subject is randomized into the intervention group, she will receive targeted interventions to reduce one of several risk factors: smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate BMI.
A woman who is randomized to the intervention group may receive interventions on one, two, three, four, or five of the targeted intervention methods, depending on her needs.
|
|
Annen: Usual Care Group
This group will receive usual care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in PTB rate among women with a prior PTB can be achieved through interconceptional interventions targeting multiple as opposed to single risk factors.
Tidsramme: Women in the intervention group will be assessed every 6 months through 24 months, unless they become pregnant, in which case they will be seen at 20 weeks EGA with their subsequent pregnancy.
|
If women do not become pregnant during the evaluation period of 24 months, they will be seen for study visits every 6 months, and will be seen more often for intervention measures to take place, as needed.
For those who become pregnant in the evaluation period, they will be assessed at 20 weeks EGA with their subsequent pregnancy, and asked to sign a release for their subsequent pregnancy records.
|
Women in the intervention group will be assessed every 6 months through 24 months, unless they become pregnant, in which case they will be seen at 20 weeks EGA with their subsequent pregnancy.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jennifer Culhane, MD, Children's Hospital of Philadelphia
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB#09-007191
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. .