- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05358483
PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health (PROMISE)
27. april 2022 opdateret af: Emily Jungheim, Northwestern University
The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
The goal of the PROMISE study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
The overall goal of the PROMISE study is to identify strategies to improve health outcomes for women and their children.
The proposed study is important and novel as it aims to capture women before they are pregnant.
Current research on maternal and child health often focuses on women who are already pregnant.
This time period is likely too late to make a meaningful clinical impact on long term maternal and child health outcomes influenced by social and epidemiologic determinants of health as important epigenetic changes are or have already taken place.
Examples of tools that will be used to capture social and epidemiologic data include validated surveys for nutrition, physical activity, sleep, and stress.
The importance of these tools is that many of the data points captured are modifiable, and therefore if associations are noted between these data points and health outcomes, actionable interventions may be developed and implemented for women who are preconceptional.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
1000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Emily Jungheim, MD, MSCI
- Telefonnummer: 312-926-6643
- E-mail: Emily.Jungheim@nm.org
Undersøgelse Kontakt Backup
- Navn: Jessica Almgren-Bell, BA
- Telefonnummer: 312-694-6678
- E-mail: Jessica.almgrenbell@nm.org
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern Medicine Fertility and Reproductive Medicine
-
Kontakt:
- Jessica Almgren-Bell, BA
- Telefonnummer: 312-694-6678
- E-mail: Jessica.almgrenbell@nm.org
-
Kontakt:
- Emily Jungheim, MD, MSCI
- E-mail: Emily.Jungheim@nm.org
-
-
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
18 år til 44 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The PROMISE Study is enrolling women undergoing IVF for the first time without use of a gestational carrier or donor oocytes.
Beskrivelse
Inclusion Criteria:
Women ages 18-44 seeking pregnancy at Northwestern Fertility and Reproductive Medicine (FRM) who agree to
- Be followed for a period for up to 25 years
- Share information regarding their child's health
- No prior IVF cycles
Exclusion Criteria:
- Women using donor oocytes or gestational carriers
- Inability or unwillingness to provide informed consent for any aspects of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Live birth after embryo transfer
Tidsramme: ~0-24 months
|
Live birth after embryo transfer (y/n)
|
~0-24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cycle number
Tidsramme: ~0-24 months
|
IVF cycle number
|
~0-24 months
|
AMH
Tidsramme: ~0-24 months
|
Most recent AMH
|
~0-24 months
|
Antral follicle count (AFC)
Tidsramme: ~0-24 months
|
Most recent AFC
|
~0-24 months
|
Diagnosis/reason for ART
Tidsramme: ~0-24 months
|
E.g., male factor, DOR, tubal factor
|
~0-24 months
|
Stimulation type
Tidsramme: ~0-24 months
|
Antagonist, microcode flare, long agonist, minimal stimulation
|
~0-24 months
|
Total gonadotropin dose (IU/L)
Tidsramme: ~0-24 months
|
Total gonadotropin dose
|
~0-24 months
|
Maximum estradiol level (pmol/L)
Tidsramme: ~0-24 months
|
Maximum estradiol level
|
~0-24 months
|
Days of stimulation
Tidsramme: ~0-24 months
|
Total number of days of stimulation
|
~0-24 months
|
Trigger type
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Sperm source
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Number follicles >14 mm
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Cycle cancellation
Tidsramme: ~0-24 months
|
Cycle cancellation (Y/N).
If Y, reason for cancellation
|
~0-24 months
|
Number of oocytes retrieved
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Number of mature oocytes
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Number of blastocysts
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Number of embryos transferred
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Day of embryo transfer
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Type of embryo transfer
Tidsramme: ~0-24 months
|
Frozen or fresh embryo transfer
|
~0-24 months
|
Frozen embryo transfer protocol
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Luteal phase support
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Number of embryos cryopreserved
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Stage of embryo cryopreservation
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Grade of embryo transferred
Tidsramme: ~0-24 months
|
~0-24 months
|
|
PGT
Tidsramme: ~0-24 months
|
~0-24 months
|
|
PGT indication
Tidsramme: ~0-24 months
|
~0-24 months
|
|
PGT methodology
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Endometrial thickness
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Ovarian hyperstimulation syndrome
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Clinical outcome
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Insemination Type
Tidsramme: ~0-24 months
|
ICSI, conventional, split
|
~0-24 months
|
Singleton pregnancy
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Multiple gestation
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Asthma
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Gestational diabetes
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Insulin
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Gestational hypertension/pre-eclampsia
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Abruption
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Placental disorders
Tidsramme: ~12-36 months
|
Placenta accreta, Placenta previa, Placenta increta, Placenta percreta
|
~12-36 months
|
Intrauterine growth restriction
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Congenital malformation
Tidsramme: ~12-36 months
|
Cleft palate, genetic defect, limb defect, cardiac defect, other
|
~12-36 months
|
Thyroid disease
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Heart disease
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Renal disease
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Polyhydramnios
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Lupus
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Clinical chorioamnionitis
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Prenatal genetic testing
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Type of prenatal genetic testing
Tidsramme: ~12-36 months
|
NIPT, CVS, amniocentesis
|
~12-36 months
|
Maternal blood type
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Preconception COVID vaccination
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Pregnancy COVID vaccination
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Predelivery hospitalization
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Maternal weight at oocyte retrieval
Tidsramme: ~12-36 months
|
Weight (lbs)
|
~12-36 months
|
Maternal height at oocyte retrieval
Tidsramme: ~12-36 months
|
Height (inches)
|
~12-36 months
|
Number of mature oocytes inseminated
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Number of mature oocytes fertilized (2PN)
Tidsramme: ~0-24 months
|
~0-24 months
|
|
Maternal weight at embryo transfer
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Maternal weight at last OB visit
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Maternal weight at 1 year postpartum
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Date of delivery
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Time of delivery
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Weight at delivery
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Mode of delivery
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Preterm birth
Tidsramme: ~12-36 months
|
Birth <37 weeks
|
~12-36 months
|
Spontaneous preterm birth
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Presentation of spontaneous preterm birth (if applicable)
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Tocolytic medication during pregnancy
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Gestational age at delivery
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Presentation of term birth (if applicable)
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Magnesium sulfate administered
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Intrapartum antibiotics
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Length of hospital stay
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Head circumference
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Maternal mortality
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Infection
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Anesthetic complication
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Antepartum hemorrhage
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Postpartum hemorrhage
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Blood transfusion
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Thromboembolism
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Birthweight
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Small-for-gestational age
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Large-for-gestational age
Tidsramme: ~12-36 months
|
~12-36 months
|
|
1-min APGAR score
Tidsramme: ~12-36 months
|
~12-36 months
|
|
5-min APGAR score
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Arterial umbilical cord pH
Tidsramme: ~12-36 months
|
~12-36 months
|
|
Breastfeeding compliance
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Postpartum weight change
Tidsramme: ~12-48 months
|
~12-48 months
|
|
General well-being
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Length of NICU stay
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Neonatal death
Tidsramme: ~12-48 months
|
<28 days post delivery
|
~12-48 months
|
Breastfeeding
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Supplemental formula
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Breastfeeding at 1 year of life
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Child weight at 1 year of life
Tidsramme: ~12-48 months
|
~12-48 months
|
|
Child height at 1 year of life
Tidsramme: ~12-48 months
|
~12-48 months
|
|
NICU admission
Tidsramme: ~12-48 months
|
~12-48 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Emily Jungheim, MD, MCSI, Division Chief of Reproductive Endocrinology and Infertility
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 (Faktiske)
7. september 2021
Primær færdiggørelse (Forventet)
1. december 2046
Studieafslutning (Forventet)
1. december 2046
Datoer for studieregistrering
Først indsendt
15. december 2021
Først indsendt, der opfyldte QC-kriterier
27. april 2022
Først opslået (Faktiske)
3. maj 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STU00215252
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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 .