Biomarkers in Obstetrical Complications
Condition: Pregnancy; Preterm Labor; Maternal Fetal Factors; Preterm Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Observational

Summary: 
      Objective: To study the natural history of normal pregnancy and the most frequent pregnancy
      complications responsible for the excessive rate of perinatal morbidity and mortality, in
      order to develop models to predict the occurrence of these complications of pregnancy at the
      earliest possible time. The study focuses on the prediction of preterm labor with intact
      membranes, preterm prelabor rupture of membranes (PROM), preeclampsia, small for gestational
      age, gestational diabetes, and fetal death. These complications account for a minimum of $30
      billion annually in the US alone.

      Study population: A cohort of pregnant women seeking care at the prenatal clinic of the
      Perinatology Research Branch in Detroit, Michigan.

      Design: A prospective observational cohort study of the natural history of women with a
      normal pregnancy, a history of adverse outcome, or those with a complication in the index
      pregnancy; therefore, this study will include nulliparous and parous women. Data will be
      collected at the time of clinic visits and will include interviews, clinical measurements,
      and ultrasound studies. We will assemble a biorepository of maternal biological fluids
      (blood, urine, saliva, cervicovaginal fluid, gingival crevicular fluid, swabs to characterize
      microbiota, amniotic fluid when a clinically indicated amniocentesis is performed). Placentas
      will be collected at the time of delivery as well as umbilical blood, and swabs to
      characterize the neonatal microbiota. We will use a retrospective case control and
      case-cohort design to generate models for the prediction of the most common pregnancy
      complications. These models will be developed by classifying obstetrical complications
      according to clinical presentation and histologic placental lesions. Models will be developed
      and subsequently validated in an independent cohort.

      Outcome measures: The goal is to develop sensitive, specific, and parsimonious predictive
      models to identify the patients at risk for developing complications of pregnancy using a
      combination of clinical and biological markers (biochemical and biophysical).
    

Detailed description: 
      Objective: To study the natural history of normal pregnancy and the most frequent pregnancy
      complications responsible for the excessive rate of perinatal morbidity and mortality, in
      order to develop models to predict the occurrence of these complications of pregnancy at the
      earliest possible time. The study focuses on the prediction of preterm labor with intact
      membranes, preterm prelabor rupture of membranes (PROM), preeclampsia, small for gestational
      age, gestational diabetes, and fetal death. These complications account for a minimum of $30
      billion annually in the US alone.

      Study population: A cohort of pregnant women seeking care at the prenatal clinic of the
      Perinatology Research Branch in Detroit, Michigan.

      Design: A prospective observational cohort study of the natural history of women with a
      normal pregnancy, a history of adverse outcome, or those with a complication in the index
      pregnancy; therefore, this study will include nulliparous and parous women. Data will be
      collected at the time of clinic visits and will include interviews, clinical measurements,
      and ultrasound studies. We will assemble a biorepository of maternal biological fluids
      (blood, urine, saliva, cervicovaginal fluid, gingival crevicular fluid, swabs to characterize
      microbiota, amniotic fluid when a clinically indicated amniocentesis is performed). Placentas
      will be collected at the time of delivery as well as umbilical blood, and swabs to
      characterize the neonatal microbiota. We will use a retrospective case control and
      case-cohort design to generate models for the prediction of the most common pregnancy
      complications. These models will be developed by classifying obstetrical complications
      according to clinical presentation and histologic placental lesions. Models will be developed
      and subsequently validated in an independent cohort.

      Outcome measures: The goal is to develop sensitive, specific, and parsimonious predictive
      models to identify the patients at risk for developing complications of pregnancy using a
      combination of clinical and biological markers (biochemical and biophysical).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attending Detroit Medical Center prenatal clinics in Detroit.
      
Keywords: Prematurity; Perinatal Mortality; Pregnancy Complications; Prediction of Adverse Pregnancy Outcome; Premature Rupture of Membranes; Natural History