Preterm BirthNCT00342277
Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition
An observational study of Preterm Birth and Premature Rupture of Membranes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in 4 countries.
Trial summary
The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth, Premature Rupture of Membranes
- How many people
- 6,838 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 21 Dec 1999to 5 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women aged 15 years and older at 18 - 36 weeks of gestation admitted with the following diagnoses:@@@1) preterm labor with intact membranes@@@2) preterm delivery without labor@@@3) PROM leading to preterm delivery@@@4) Term deliveries without labor/spontaneous labor/with chorioamnionitis/with failed labor leading to cesarean section
Who may be able to join
- Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):
- Preterm labor with intact membranes and with
- acute inflammation;
- chronic villitis;
- vascular pathology;
- no identifiable lesions.
Show all 20Show fewer
- Preterm delivery without labor because of the following reasons:
- pre-eclampsia;
- abruptio placentae;
- fetal anomalies;
- Other complications (e.g. automobile accidents) that necessitate immediate delivery.
- PROM leading to preterm delivery and with
- acute inflammation;
- chronic villitis;
- vascular pathology;
- no identifiable lesions.
- Term delivery without labor and no identifiable lesions.
- Term delivery in spontaneous labor and no identifiable lesions.
- Term delivery with chorioamnionitis.
- Term delivery with failed labor leading to ceasarean section.
Who cannot join
- Refusal of written informed consent
- Fetal or maternal conditions mandating immediate delivery (i.e. fetal distress, significant hemorrhage, etc.)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.
Read the detailed description
The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.
- Conditions
- Preterm Birth, Premature Rupture of Membranes
- Keywords
- Genetic Risk Factors, Tissue Specific Expression, Quantitative Real Time PCR, Preterm Birth, Expression Profiling, Natural History
- Medical subject headings
- Premature Birth, Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Consecutive pregnant women admitted with either: Preterm labor/delivery/PROM. Termdelivery without labor/spontaneous labor /chorioamnionitis/failed labor leading to c-section |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling.
Investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available.
Measured: After the study is closed to accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start21 Dec 1999
- Primary completion5 May 2016
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,838 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roberto Romero, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342277
- Sponsor's protocol ID
- 999999056
- Other IDs
- OH99-CH-N056
- Status last verified
- Feb 2023
- First submitted
- 19 Jun 2006
- Last updated
- 24 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition
- ClinicalTrials.gov ID
- NCT00342277
- Acronym / sponsor ID
- 999999056
- Conditions
- Preterm Birth, Premature Rupture of Membranes
- Keywords
- Genetic Risk Factors, Tissue Specific Expression, Quantitative Real Time PCR, Preterm Birth, Expression Profiling, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,838 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 21 Dec 1999 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 21 Jun 2006 (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 understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.
Detailed description
The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | –Consecutive pregnant women admitted with either: Preterm labor/delivery/PROM. Termdelivery without labor/spontaneous labor /chorioamnionitis/failed labor leading to c-section |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women aged 15 years and older at 18 - 36 weeks of gestation admitted with the following diagnoses:@@@1) preterm labor with intact membranes@@@2) preterm delivery without labor@@@3) PROM leading to preterm delivery@@@4) Term deliveries without labor/spontaneous labor/with chorioamnionitis/with failed labor leading to cesarean section
Key inclusion criteria (20 listed)
- Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):
- Preterm labor with intact membranes and with
- Preterm delivery without labor because of the following reasons:
- PROM leading to preterm delivery and with
- Term delivery without labor and no identifiable lesions.
Key exclusion criteria (2 listed)
- Refusal of written informed consent
- Fetal or maternal conditions mandating immediate delivery (i.e. fetal distress, significant hemorrhage, etc.)
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
To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling.
Time frame: After the study is closed to accrual
Investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Related trials for Preterm Birth
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
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. This study is not recruiting at the moment.
Roberto Romero, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Premature Rupture of Membranes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in 4 countries.
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 20 inclusion and 2 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: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Chile, Italy, South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling. (time frame: After the study is closed to accrual). 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 24 Feb 2023.