PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
- Conditions
- Infertility, Female
- Registration Number
- NCT05358483
- Lead Sponsor
- Northwestern University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
-
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
- Women using donor oocytes or gestational carriers
- Inability or unwillingness to provide informed consent for any aspects of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Live birth after embryo transfer ~0-24 months Live birth after embryo transfer (y/n)
- Secondary Outcome Measures
Name Time Method Lupus ~12-36 months Date of delivery ~12-36 months Time of delivery ~12-36 months Maternal height at oocyte retrieval ~12-36 months Height (inches)
Maternal weight at last OB visit ~12-36 months Maternal weight at 1 year postpartum ~12-36 months Number of embryos transferred ~0-24 months Renal disease ~12-36 months Intrapartum antibiotics ~12-36 months Gestational age at delivery ~12-36 months Presentation of spontaneous preterm birth (if applicable) ~12-36 months Maternal mortality ~12-36 months Anesthetic complication ~12-36 months Blood transfusion ~12-36 months AMH ~0-24 months Most recent AMH
Thromboembolism ~12-36 months PGT indication ~0-24 months Stimulation type ~0-24 months Antagonist, microcode flare, long agonist, minimal stimulation
Abruption ~12-36 months Number of oocytes retrieved ~0-24 months Intrauterine growth restriction ~12-36 months Antral follicle count (AFC) ~0-24 months Most recent AFC
Maximum estradiol level (pmol/L) ~0-24 months Maximum estradiol level
Cycle cancellation ~0-24 months Cycle cancellation (Y/N). If Y, reason for cancellation
Type of embryo transfer ~0-24 months Frozen or fresh embryo transfer
Ovarian hyperstimulation syndrome ~0-24 months Clinical outcome ~0-24 months Cycle number ~0-24 months IVF cycle number
Diagnosis/reason for ART ~0-24 months E.g., male factor, DOR, tubal factor
Days of stimulation ~0-24 months Total number of days of stimulation
Number of embryos cryopreserved ~0-24 months Stage of embryo cryopreservation ~0-24 months Endometrial thickness ~0-24 months Singleton pregnancy ~12-36 months Insulin ~12-36 months Total gonadotropin dose (IU/L) ~0-24 months Total gonadotropin dose
Trigger type ~0-24 months Number of blastocysts ~0-24 months Day of embryo transfer ~0-24 months Frozen embryo transfer protocol ~0-24 months Luteal phase support ~0-24 months PGT ~0-24 months Sperm source ~0-24 months Number follicles >14 mm ~0-24 months Number of mature oocytes ~0-24 months Grade of embryo transferred ~0-24 months PGT methodology ~0-24 months Insemination Type ~0-24 months ICSI, conventional, split
Asthma ~12-36 months Gestational hypertension/pre-eclampsia ~12-36 months Length of NICU stay ~12-48 months Maternal weight at oocyte retrieval ~12-36 months Weight (lbs)
Neonatal death ~12-48 months \<28 days post delivery
Prenatal genetic testing ~12-36 months Type of prenatal genetic testing ~12-36 months NIPT, CVS, amniocentesis
Polyhydramnios ~12-36 months Number of mature oocytes inseminated ~0-24 months Weight at delivery ~12-36 months Mode of delivery ~12-36 months Length of hospital stay ~12-36 months Large-for-gestational age ~12-36 months Breastfeeding at 1 year of life ~12-48 months Multiple gestation ~12-36 months Gestational diabetes ~12-36 months Placental disorders ~12-36 months Placenta accreta, Placenta previa, Placenta increta, Placenta percreta
Heart disease ~12-36 months Predelivery hospitalization ~12-36 months Maternal weight at embryo transfer ~12-36 months Spontaneous preterm birth ~12-36 months Tocolytic medication during pregnancy ~12-36 months Presentation of term birth (if applicable) ~12-36 months Postpartum weight change ~12-48 months Child height at 1 year of life ~12-48 months Congenital malformation ~12-36 months Cleft palate, genetic defect, limb defect, cardiac defect, other
Thyroid disease ~12-36 months Pregnancy COVID vaccination ~12-36 months Number of mature oocytes fertilized (2PN) ~0-24 months Preterm birth ~12-36 months Birth \<37 weeks
Head circumference ~12-36 months Infection ~12-36 months 5-min APGAR score ~12-36 months Supplemental formula ~12-48 months Clinical chorioamnionitis ~12-36 months Maternal blood type ~12-36 months Preconception COVID vaccination ~12-36 months Magnesium sulfate administered ~12-36 months Antepartum hemorrhage ~12-36 months Postpartum hemorrhage ~12-36 months Birthweight ~12-36 months Small-for-gestational age ~12-36 months Arterial umbilical cord pH ~12-36 months Breastfeeding compliance ~12-48 months 1-min APGAR score ~12-36 months General well-being ~12-48 months Breastfeeding ~12-48 months NICU admission ~12-48 months Child weight at 1 year of life ~12-48 months
Trial Locations
- Locations (1)
Northwestern Medicine Fertility and Reproductive Medicine
🇺🇸Chicago, Illinois, United States