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Blood DNA levels may signal pregnancy problems

NCT ID NCT01736826

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study measured the amount of free-floating DNA and nucleosomes in the blood of 137 women to see if these levels differ between those with pregnancy complications (like preeclampsia or blood clots) and healthy women (both pregnant and non-pregnant). The goal was to better understand these markers, not to treat or cure any condition. Results could help future research on detecting pregnancy risks.

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Study facts

What this study's own registry entry says, in plain language.

Participants

137 people

The number who actually took part.

Start date

Jun 2015

Finished

Dec 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes three groups: Group P: 100 pregnant women with complications typical of placental vascular disease or venous thromboembolism. Group T1: 30 non-pregnant, healthy volunteers * The first 15 patients from group T1 will form group T1x. The latter group has two months of additional follow up. Group T2: 50 pregnant, healthy volunteers * The first 15 patients from group T2 will form group T2x. The latter group has 7 months of follow-up during pregnancy.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for all patients: * The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan Inclusion Criteria for patients in group P: * The patient is pregnant and has complications typical of placental vascular disease (preeclampsia, eclampsia, HELLP syndrome, retro-placental hematoma, in utero fetal death) or venous thromboembolism (deep vein thrombosis, pulmonary embolism) Inclusion Criteria for patients in group T1: * The patient is available for 3 months of follow-up * The patient is a non-pregnant healthy volunteer * No identifiable chronic pathologies * No history of neoplastic disease * No history of chronic infectious disease * No acute disease (such as benign infection), now or within the past two weeks Inclusion Criteria for patients in group T2: * The patient is available for 7 months of follow-up * The patient is pregnant, with no identifiable pregnancy complications * No identifiable chronic pathologies * No history of neoplastic disease * No history of chronic infectious disease * No acute disease (such as benign infection), now or within the past two weeks Exclusion Criteria for all patients: * The patient is participating in another study (with the exception of the following studies: PAPILLO-PMA (2013-A00538-37), ElastoMAP (2013-A01148-37), ElastoDéclenche (2014-A00828-39), LXRs (2009-A00968-49), Bakri (2013-A00914-41), OASIS 2 (2013-A00022-43)). * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient cannot read French * The patient is receiving hormonal ovarian stimulation in the context of medically assisted procreation * Impossible to perform venipuncture under good conditions * New complication or pathology during the study (except for pregnancy complications in group P) Exclusion Criteria for group P: * Twin or multiple pregnancy * The patient is participating in another study (with the exception of those mentioned in the exclusion criteria for all patients and the DG Postpartum study (2013-A00277-38) Exclusion Criteria for group T1: * The patient is pregnant * The patient is breast feeding * The patient has given birth within the last 3 months * Known history of chronic disease * History of treated neoplastic disease * Acute disease within the past two weeks (includes benign disease) Exclusion Criteria for group T2: * Pregnancy with complications * Known history of chronic disease * History of treated neoplastic disease * Acute disease within the past two weeks (includes benign disease) * Twin or multiple pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.