ClinicalTrials.gg
RecruitingNCT03313024BBPCUpdated Aug 14, 2018

Berlin-Brandenburg Pregnancy Cohort

An observational study in Preeclampsia, Pregnancy Complications and Diabetes Mellitus in Pregnancy, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Charite University, Berlin, Germany · Observational

From the registry’s dates

  • Started Sep 2017; still recruiting 9 years 1 month later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,580
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Pre-Eclampsia with a site in Germany — 6 open to participants now, 6 under way, none of them phase 3. Pre-Eclampsia · Germany.

Planned enrollment
Largest of 10
1,580 · median 253
Started
2017
with 2 others
Observational
10 of 17
6 open now
Registered
7th of 17
by date
Lead sponsor
4 of 17
Charite University, Berlin, Germany

Among the 17 studies in Pre-Eclampsia with a site in Germany, this one has the largest planned enrollment of the 10 observational ones that give a count, is one of 3 that started in 2017, is one of 10 observational ones, and was the 7th registered.

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

Browse Pre-Eclampsia studies →

Open to participants now

6 of the 17 studies in Pre-Eclampsia with a site in Germany are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.

This study: 18 Years to 45 Years · female · healthy volunteers too.

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02

Study 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, 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.

03

Conditions studied

  • Preeclampsia
  • Pregnancy Complications
  • Diabetes Mellitus in Pregnancy
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnant women between 18 and 45 years of age without infections, severe or chronic diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy pregnant women after giving
  • pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes

Exclusion criteria

Exclusion Criteria:

  • infections
  • alcohol and drug abuse
  • manifest and chronic diseases
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,580 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Experimental and Clinical Research Center (ECRC)
    Berlin, 13125, Germany
    Recruiting
    • Florian Herse, PhD · Contactflorian.herse@charite.de · +49 30 450 540 434
    • Florian Herse, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Oct 2027, 121 months after the start.

Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 121 months is above that.

Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2017
First posted
Oct 18, 2017
StartActual
Sep 26, 2017
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Aug 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03313024
Responsible party
Florian Herse (PhD, Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 18, 2017
Start date
Sep 26, 2017
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 14, 2018

Study contacts

Florian Herse, PhD
Contact
florian.herse@charite.de
+49 30 450 540 434

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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