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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

Undersøgelse Kontakt Backup

Studiesteder

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

    1. Be followed for a period for up to 25 years
    2. 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.

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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