The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Live birth after embryo transfer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Women using donor oocytes or gestational carriers
- •Inability or unwillingness to provide informed consent for any aspects of the study
结局指标
主要结局
Live birth after embryo transfer
时间窗: ~0-24 months
Live birth after embryo transfer (y/n)
次要结局
- Lupus(~12-36 months)
- Date of delivery(~12-36 months)
- Time of delivery(~12-36 months)
- Maternal height at oocyte retrieval(~12-36 months)
- Maternal weight at last OB visit(~12-36 months)
- Maternal weight at 1 year postpartum(~12-36 months)
- Multiple gestation(~12-36 months)
- Intrauterine growth restriction(~12-36 months)
- Presentation of spontaneous preterm birth (if applicable)(~12-36 months)
- AMH(~0-24 months)
- PGT indication(~0-24 months)
- Stimulation type(~0-24 months)
- Number of oocytes retrieved(~0-24 months)
- Antral follicle count (AFC)(~0-24 months)
- Maximum estradiol level (pmol/L)(~0-24 months)
- Cycle cancellation(~0-24 months)
- Number of embryos transferred(~0-24 months)
- Type of embryo transfer(~0-24 months)
- Ovarian hyperstimulation syndrome(~0-24 months)
- Clinical outcome(~0-24 months)
- Abruption(~12-36 months)
- Cycle number(~0-24 months)
- Diagnosis/reason for ART(~0-24 months)
- Days of stimulation(~0-24 months)
- 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)
- Asthma(~12-36 months)
- Total gonadotropin dose (IU/L)(~0-24 months)
- 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)
- Gestational hypertension/pre-eclampsia(~12-36 months)
- Renal disease(~12-36 months)
- Length of NICU stay(~12-48 months)
- Maternal weight at oocyte retrieval(~12-36 months)
- Neonatal death(~12-48 months)
- Prenatal genetic testing(~12-36 months)
- Type of prenatal genetic testing(~12-36 months)
- 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)
- Gestational diabetes(~12-36 months)
- Placental disorders(~12-36 months)
- 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)
- 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)
- Intrapartum antibiotics(~12-36 months)
- 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)
- Gestational age at delivery(~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)
- Maternal mortality(~12-36 months)
- Anesthetic complication(~12-36 months)
- Blood transfusion(~12-36 months)
- Thromboembolism(~12-36 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)
研究者
Emily Jungheim
Chief of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology
Northwestern University