At High-risk for Pre-eclampsia After Assisted Reproductive Technology
CRG UZ Brussel
1,050 participants
Feb 15, 2023
OBSERVATIONAL
Conditions
Summary
The overarching goal of the project is to unravel PE etiopathogenesis in high-risk patients (PCOS patients and oocyte acceptors) after assisted reproductive technology (ART) to individualize prenatal care following ART and to determine potential targets for new PE prevention options decreasing the morbidity/mortality caused by this pathology. More specifically, the following objectives/work packages (WPs) are put forward: * WP1 - PRECONCEPTION: Identify preconceptional maternal characteristics associated with in-creased risk of PE in ART patients (1a) and investigate the potential role of the endometrium prior to pregnancy (1b). * WP2 - DURING PREGNANCY: Evaluate the Fetal Medicine Foundation's (FMF) first trimester PE screening in selected high-risk groups post ART to explore the clinical benefit in this specific context (2a) and investigate the association between parameters during the pregnancy and PE development post-ART. * WP3 - AT DELIVERY: Identifying placental molecular pathways associated with PE post-ART.
Eligibility
Inclusion Criteria11
- First time oocyte acceptors Or Nulliparous PCOS patients undergoing ART (IVF/ICSI)
- Criteria for PCOS: two out of the three following criteria must be present:
- Oligo-or anovulation: a menstrual cycle >35 days
- Hyperandrogenism:
- Clinically: the presence of hirsutism and/ or severe acne in combination with alopecia confirmed hyperandrogenism Or
- Biochemically: serum total testosterone >52 ng/dl or calculated free testosterone >0,64 ng/dl
- Polycystic ovaries:
- Follicle number per ovary (FNPO) ≥ 12 on both ovaries Or
- Ovarian volume ≥ 10 ml in both ovaries Or
- One ovary with ≥ 20 follicles (Using endovaginal US transducers with a frequency bandwidth that includes 8 MHz) Or
- AMH ≥ 4,9 ng/ml
Exclusion Criteria24
- Known essential hypertension or development of a new-onset hypertension before 20 weeks' gestation
- Hypertension is defined as a systolic blood pressure ≥ 140 or a diastolic blood pressure ≥ 90 on two separate measurements with at least 20 minutes in between, taken when the patients is in a seated position Or
- The patient is known with hypertension, diagnosed by a certified doctor
- Known diabetes type 1 or 2 before pregnancy
- Diagnosis of diabetes is confirmed when one of the following is present:
- Fasting glucose ≥ 126 mg/dl
- A 2-hour plasma glucose level ≥ 200 mg/dL during a 75-g oral glucose tolerance test Or
- The patient is known with diabetes (type 1 or 2), diagnosed by a certified doctor
- Thyroid dysfunction not under control with medication:
- Hyperthyroidism, the diagnoses is made when:
- Peripheral blood TSH <0,5 mIU/L and fT4 >1,9 ng/dl Or
- When the patient is known with hyperthyroidism diagnosed by a certified physician
- Hypothyroidism, the diagnosis is made when:
- Peripheral blood TSH >5 mIU/L and fT4 <0,7 ng/dl Or
- When the patient is known with hypothyroidism diagnosed by a certified physician
- Other endocrinological disorder (including Cushing syndrome, Adrenal insufficiency, acromegaly): for diagnosis we will trust the opinion of the certified endocrinologist
- Cardiovascular diseases (including coronary artery disease, arrhythmia, heart valve disease and heart failure): for diagnosis we will trust the opinion of the certified cardiologist
- Renal disease/insufficiency: for diagnosis we will trust the opinion of the certified nephrologist
- Systemic lupus erythematosus: for diagnosis we will trust the opinion of the certified internal medicine doctor
- Antiphospholipid syndrome: for diagnosis we will trust the opinion of the certified internal medicine doctor
- Liver dysfunction/disease: for diagnosis we will trust the opinion of the certified gastroenterologist
- History of prior pre-eclampsia
- Women pregnant with a fetus with known abnormalities such chromosomal anomalies, structural deformities of limbs or organs or any other prebirth diagnosed syndromes or defects
- Multiple pregnancy
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Interventions
The procedure is performed without any anesthesia and takes approximately 5 minutes. A small plastic pipelle is put through the cervix into the uterine cavity. The endometrial tissue is aspirated into the pipelle.
Evaluation of fetal biometry and doppler flow study using ultrasound.
single puncture collection of peripheral venous blood.
Collection of urine in a plastic cup.
Start with daily estradiol (progynova, oestrogel) administration at hormonal baseline (day 2 of the cycle or with confirmation using endocrine evaluation). When adequate thickness (≥6.5 mm) of the endometrium is achieved (usually after 10-14 days), progesterone is administered daily. 6 days after progesterone administration, the pipelle biopsy will be performed. When this test cycle has ended and menstruation starts, patients will be asked to collect their menstrual flow, during the first night of heavy/red flow, in a menstrual cup. The next day patients will be asked to bring their collected menstrual blood to our center and they will undergo a blood analysis needed for the start of their ART treatment.
questionnaire the patient has to fill in
collection of menstrual blood during the first day of heavy menstrual flow for at least 6 hours
Including body composition analysis by BIA/whole body MRI and analysis of resting energy expenditure (REE).
Using transthoracic ultrasound.
Blood pressure measurement
Locations(1)
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NCT05746793