PregnancyNCT02321007
Study of Placental Function in Healthy and Pathological Pregnancies
An observational study of Pregnancy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women delivering at term as well as women with pregnancy complications such as pre-term birth, intrauterine growth restriction, diabetes and obesity will be eligible for the study.
Who may be able to join
- Healthy women delivering at term
- Women with pregnancy complications such as:
- pre-term birth,
- intrauterine growth restriction,
- diabetes, and
- obesity.
Who cannot join
- Women:
- under stress,
- experiencing pain of labor.
- Pregnancies complicated by other pathologies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Anita Kramer, 303-724-1653, anita.kramer@ucdenver.edu
Thomas Jansson, MD, PhD
About this study
The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.
- Conditions
- Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting, processing, and archiving human specimens from 1250 subjects
Human placental tissue, umbilical cord blood, and maternal blood samples will be collected from pregnant women at the time of their delivery. The samples will be used to enhance understanding of the role of the placenta in the development of pregnancy complications and in programming of adult disease.
Measured: Specimens will be stored for 50 years in repository
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Jansson, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321007
- Sponsor's protocol ID
- 14-1073
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2014
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Placental Function in Healthy and Pathological Pregnancies
- ClinicalTrials.gov ID
- NCT02321007
- Acronym / sponsor ID
- 14-1073
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women delivering at term as well as women with pregnancy complications such as pre-term birth, intrauterine growth restriction, diabetes and obesity will be eligible for the study.
Key inclusion criteria (6 listed)
- Healthy women delivering at term
- Women with pregnancy complications such as:
Key exclusion criteria (4 listed)
- Women:
- Pregnancies complicated by other pathologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collecting, processing, and archiving human specimens from 1250 subjects
Time frame: Specimens will be stored for 50 years in repository
Human placental tissue, umbilical cord blood, and maternal blood samples will be collected from pregnant women at the time of their delivery. The samples will be used to enhance understanding of the role of the placenta in the development of pregnancy complications and in programming of adult disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Jansson, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Kramer (303-724-1653, anita.kramer@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting, processing, and archiving human specimens from 1250 subjects (time frame: Specimens will be stored for 50 years in repository). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.