Biomarkers in Obstetrical Complications
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | January 30, 2030 |
| Contact: | Roberto Romero, M.D. |
| Email: | romeror@mail.nih.gov |
| Phone: | (313) 993-2700 |
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).
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).
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).
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).
- INCLUSION CRITERIA:
This prospective longitudinal cohort study will recruit consecutive pregnant women aged 18
years or more who are between 6 and 26 6/7 weeks of gestation receiving care at the Detroit
Medical Center. Informed consent will be administered prior to any research procedures.
EXCLUSION CRITERIA:
Women who have high order, multiple gestations (greater than or equal to 3 fetuses) or any
of the following conditions are ineligible for participation in the study: active vaginal
bleeding; serious medical illness (e.g. renal insufficiency, congestive heart disease, and
chronic respiratory insufficiency)
EXCLUSION CRITERIA (for MRI examination only):
- Inability to perform MRI scan due to maternal habitus
- Metallic implants that would increase risk to the patient for MRI examination
- Previous occupational exposure to metal
- History of claustrophobia
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