An observational study in Pregnancy, Preterm Labor and Maternal Fetal Factors, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
Among 16 studies in Premature Birth by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) — none open to participants now, none under way, none of them phase 3. Premature Birth · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Among the 16 studies in Premature Birth by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), this one is the 7th largest by enrollment of the 10 observational ones that give a count, is the only one that started in 2018, is one of 10 observational ones, and was the 16th registered.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
Browse Premature Birth studies →None of the 16 studies in Premature Birth by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is open now.
Of the 313 Premature Birth studies recruiting now, 87 (28%) set no upper age limit and 222 (71%) stop at 75 or younger; 239 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 1 started in 2018.
This study's enrollment of 746 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Median enrollment 132 across the 6 interventional studies, 4,162 across the 10 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Premature Birth by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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).
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).
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 746 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Compared within Premature Birth, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obstetric Labor, Premature. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Pregnant women attending Detroit Medical Center prenatal clinics in Detroit.
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. 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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women aged 18 years and older
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).
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
Time frame: After the study is closed to accrual
Ran from Feb 2018 to primary completion in Mar 2023, 60 months.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's 60 months is above that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) →