Preterm BirthNCT03796949
Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model
An observational study of Preterm Birth and Immunologic Activity Alteration, run by Linkoeping University.
Trial summary
This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Immunologic Activity Alteration
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Sep 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 women with threatened preterm labor before 34 weeks of gestation, 40 women with preterm prelabor rupture of the membranes before 34 weeks of gestation, 40 women with normal pregnancies in labor at term, 44 women with normal pregnancies during pregnancy (before labor)
Who may be able to join
- Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes
- Age > 18 years
- Swedish-speaking (understanding study information)
Who cannot join
- Multiple gestation
- Blood borne infections
About this study
Official title: Threatened Preterm Birth and Time of Subsequent Delivery; Prediction Model Based on Biomarkers and Maternal/Obstetrical Characteristics
This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.
Read the detailed description
Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated.
In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor.
Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.
- Conditions
- Preterm Birth, Immunologic Activity Alteration
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| threatened preterm birth | Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study. | |
| Controls | Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of delivery
Delivery before 34 weeks of gestation or after 34 weeks of gestation
Measured: Outcome noted at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study startMay 2014
- Primary completionAug 2018
- Study completionSep 2018
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.
- More trials run by Linkoeping UniversityThe 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marie Blomberg, Linkoeping University
- Investigators
- Marie Blomberg, MD PhD, Principal investigator, Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796949
- Sponsor's protocol ID
- 960624abc
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Threatened Preterm Birth and Time of Subsequent Delivery; Prediction Model Based on Biomarkers and Maternal/Obstetrical Characteristics
- ClinicalTrials.gov ID
- NCT03796949
- Acronym / sponsor ID
- 960624abc
- Conditions
- Preterm Birth, Immunologic Activity Alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 8 Jan 2019 (actual)
- 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.
This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.
Detailed description
Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated.
In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor.
Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| threatened preterm birth | – | –Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study. |
| Controls | – | –Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 women with threatened preterm labor before 34 weeks of gestation, 40 women with preterm prelabor rupture of the membranes before 34 weeks of gestation, 40 women with normal pregnancies in labor at term, 44 women with normal pregnancies during pregnancy (before labor)
Key inclusion criteria (3 listed)
- Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes
- Age > 18 years
- Swedish-speaking (understanding study information)
Key exclusion criteria (2 listed)
- Multiple gestation
- Blood borne infections
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
Time of delivery
Time frame: Outcome noted at delivery
Delivery before 34 weeks of gestation or after 34 weeks of gestation
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 8 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Marie Blomberg, MD PhD principal investigator
Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Immunologic Activity Alteration, run by Linkoeping University.
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 3 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Time of delivery (time frame: Outcome noted at delivery). 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 8 Jan 2019.