PreeclampsiaBBPCNCT03313024
Berlin-Brandenburg Pregnancy Cohort
An observational study of Preeclampsia and Pregnancy Complications, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia… 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
- Preeclampsia, Pregnancy Complications, Diabetes Mellitus in Pregnancy
- How many people
- 1,580 participants
- Where
- 1 siteGermany
- Study dates
- 26 Sep 2017to Oct 2027
- 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: Pregnant women between 18 and 45 years of age without infections, severe or chronic diseases
Who may be able to join
- healthy pregnant women after giving informed consent
- pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes
Who cannot join
- infections
- alcohol and drug abuse
- manifest and chronic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Experimental and Clinical Research Center (ECRC)
Berlin, 13125
Florian Herse, PhD, +49 30 450 540 434, florian.herse@charite.de
Florian Herse, PhD
About this study
Official title: Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders
This study will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes are causally involved in the formation and translation of preeclampsia by inducing an endothelial dysfunction which leads to cardiovascular damage.
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications, Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry
Measured: at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start26 Sep 2017
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Herse, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313024
- Sponsor's protocol ID
- BBPC
- Acronym
- BBPC
- Status last verified
- Aug 2018
- First submitted
- 13 Oct 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders
- ClinicalTrials.gov ID
- NCT03313024
- Acronym / sponsor ID
- BBPC / BBPC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,580 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Oct 2017 (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 will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes are causally involved in the formation and translation of preeclampsia by inducing an endothelial dysfunction which leads to cardiovascular damage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 18 and 45 years of age without infections, severe or chronic diseases
Key inclusion criteria (2 listed)
- healthy pregnant women after giving informed consent
- pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes
Key exclusion criteria (3 listed)
- infections
- alcohol and drug abuse
- manifest and chronic diseases
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
T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry
Time frame: at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy
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 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Daily Aspirin Treatment After Preeclampsia
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Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
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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.
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 Preeclampsia and Pregnancy Complications, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 3 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 14 Aug 2018. 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 Germany. 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 Florian Herse, PhD (+49 30 450 540 434, florian.herse@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry (time frame: at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy). 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 14 Aug 2018.