Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05228002
Eligibility Criteria:
Inclusion Criteria:
* Pregnant patient
* Affiliated to the Social Security
* Signature of informed consent
* Term \> 24 week of amenorrhea and \< 37 week of amenorrhea
* Single criterion among the following: (only one box below must be ticked to allow inclusion):
* de novo hypertension (PAS ≥ 140 mmHg and/or PAD ≥ 90 mmHg) ;
* worsening of pre-existing hypertension \>10 mmHg (on PAS or PAD ) ;
* worsening of pre-existing proteinuria;
* Excessive edema AND significant weight gain (minimum 2kg/week);
* Headache AND another clinical sign (edema, rapid weight gain);
* Visual disturbances (phosphenes and/or visual blur) AND/OR tinnitus;
* Sudden weight gain (\> 1kg/week during the 3rd trimester);
* Low platelet count (thrombocytopenia \< 150 G/L);
* Hepatic cytolysis (ASAT and/or ALAT \> 2N) without associated pruritus or jaundice;
* Suspicion of intrauterine growth retardation on obstetric ultrasound, with no other cause found (no hypertension or proteinuria, no clinical or biological signs of pre-eclampsia) and no abnormal fetal dopplers.
Exclusion Criteria:
* Minor patient
* Patient with poor clinical tolerance of hypertension and/or need for immediate introduction of intravenous antihypertensive therapy
* Patient with a specific complication of pre-eclampsia requiring immediate management at the time of inclusion: in utero fetal death, retroplacental hematoma, disseminated intravascular coagulation or emergency cesarean section.
* Association of at least 2 of the following criteria:
* De novo proteinuria (24h proteinuria ≥ 0.3 g/24h or P/C ratio ≥ 0.3) or worsening of pre- existing proteinuria;
* Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessive edema, headaches, visual disturbances, sudden weight gain (\> 1kg/week in the 3rd trimester);
* Biological signs associated with pre-eclampsia: low platelet count (thrombocytopenia \< 150 G/L), hepatic cytolysis (ASAT and/or ALAT \> 2N);
* Suspicion of intrauterine growth retardation on obstetrical ultrasound, with no other cause found.
A combination of at least 2 of these criteria raises the suspicion of pre-eclampsia, and, according to the new CNGOF recommendations of 2024, requires systematic initial hospitalization.
\- Vulnerable person requiring enhanced protection, i.e., relatively (or totally) unable to protect their own interests. Specifically, the person's power, intelligence, education, resources, strength, or other attributes necessary to protect his or her own interests may be inadequate (e.g., persons deprived of liberty, minors, persons under guardianship, persons with mental or emotional disabilities in the broadest sense of the word, illiterate persons, refugees and asylum seekers, alcoholics and drug addicts, etc.)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05228002
Study Brief:
Protocol Section:
NCT05228002