See if non-invasive fetal DNA testing after early miscarriage supports mental health and follow-up care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study adds cell-free fetal DNA testing to blood samples taken at the time of early miscarriage diagnosis. Results of the non-invasive prenatal test may be shared at an 8-week visit if the patient wishes, potentially informing a tailored care plan. Psychological state is tracked at 8 weeks and again at one year using HAD and PGS questionnaires to understand any impact on mental health and subsequent reproductive planning. The study is conducted at CHU Rennes with Rennes University Hospital as the lead center, focusing on patients who experience a first-trimester miscarriage and meet the eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A stopped pregnancy with an intrauterine pregnancy diagnosed by ultrasound (embryo larger than 7 mm corresponding to a gestational age of 6 weeks and 5 days. This is justified by the fact that fetal fragment (FF) detection is possible at 5 weeks of gestation, or 7 weeks and 5 days)
* Expulsion of a pregnancy within the last 2 hours

  * Patient fluent in French
  * Enrolled in a social security program
  * Has received oral and written information about the protocol and has signed a consent form to participate in this research.

Exclusion Criteria:

* Diagnosis of an empty gestational sac, ectopic pregnancy, or unknown location
* Ultrasound findings consistent with a molar pregnancy
* Identified cause (preimplantation diagnosis, multiple uterine fibroids or a single fibroid \> 5 cm, uterine malformation affecting the uterine cavity, lupus, and antiphospholipid syndrome)
* Inability to obtain a blood sample
* Known current malignant tumor
* Blood transfusions within the last 3 months
* Cell therapy or immunotherapy within the last 3 months
* Previous organ transplant

Where it's running

• CHU Rennes
  Rennes, France Recruiting

Study contacts

• Study coordinator: Marie-Laure Gervais
• Email: marie-laure.gervais@chu-rennes.fr
• Phone: 299282555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.