Biomarkers in Obstetrical Complications
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| ClinicalTrials.gov Identifier: NCT03480139 |
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Recruitment Status :
Recruiting
First Posted : March 29, 2018
Last Update Posted : December 6, 2019
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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).
| Condition or disease |
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| Pregnancy Preterm Labor Maternal Fetal Factors Preterm Birth |
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).
| Study Type : | Observational |
| Estimated Enrollment : | 10800 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Biological Markers for the Prediction of the Great Obstetrical Syndromes: A Longitudinal Study |
| Estimated Study Start Date : | December 11, 2019 |
| Estimated Primary Completion Date : | January 8, 2028 |
| Estimated Study Completion Date : | January 30, 2030 |
| Group/Cohort |
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Pregnant Women
Pregnant women aged 18 years and older
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- 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). [ Time Frame: After the study is closed to accrual ]The following will be the primary outcome measures analyzed:-Preterm delivery <37, <34, and <32 weeks-Preeclampsia-Small for gestational age neonate-Fetal death-Gestational diabetes
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480139
| Contact: Roberto Romero, M.D. | (313) 993-2700 | romeror@mail.nih.gov |
| United States, Michigan | |
| Wayne State University Hutzel Hospital | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Chaur-Dong Hsu, M.D. 313-577-8009 chsu@med.wayne.edu | |
| Principal Investigator: | Roberto Romero, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT03480139 History of Changes |
| Other Study ID Numbers: |
999918063 18-CH-N063 |
| First Posted: | March 29, 2018 Key Record Dates |
| Last Update Posted: | December 6, 2019 |
| Last Verified: | June 27, 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Prematurity Perinatal Mortality Pregnancy Complications Prediction of Adverse Pregnancy Outcome Premature Rupture of Membranes |
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |