Fetal, Obstetrics and Reproduction Genomics (FORgenomics)

Fundación Ginemed

Status: Not yet enrolling

Conditions: Preeclampsia; Intrauterine Growth Restriction; Placental Disease

Treatments: Diagnostic Test: Blood sample; Diagnostic Test: Doppler ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05720169

0001

Details and patient eligibility

About

The purpose of this study is to determine the impact of a clinical screening strategy and genomic analysis of the factors involved in Placental Dysfunction (Preeclampsia and IUGR) in women of advanced maternal age undergoing assisted reproduction techniques (ART), specifically, in vitro fertilization (IVF) and oocyte donation.

Full description

Given society's shift towards later childbearing, partly related to increased career development, women are increasingly delaying childbearing and, as a result, face declining biological fertility and increased maternal morbidity and adverse perinatal pregnancy outcomes, as well as increased use of ART. Preeclampsia (PE) complicates 2% of pregnancies and is a leading cause of severe maternal and perinatal complications. There is no curative treatment, and the only recognized beneficial primary prevention is low-dose aspirin. Finding an effective method of predicting and preventing placental dysfunction (PD) in women of advanced maternal age undergoing ART remains a challenge.

The investigators believe that maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow early preventive actions.

On the other hand, establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation. Furthermore, FORgenomics can be used to externally validate a prediction model for the development of PE and IUGR in pregnancy after IVF/ovodon. Our results could be applicable in most healthcare settings and have important implications for maternal-fetal health.

The justification and hypothesis of this proposal is: (1) maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow preventive actions by systematic screening based on Doppler ultrasound of uterine arteries and anti-angiogenic factors (sFlt-1/PlGF ratio) at 13, 16, 20 and 26 weeks to identify pregnant women at high risk for developing PE; (2) morphological ultrasound at 13, 16 and 20 weeks would help to establish a standardized procedure for early detection of congenital anomalies and (3) establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation.

Enrollment: 400 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton pregnancy
• Age ≥40 years
• Signed informed consent
• Gestation obtained by IVF or ovodonation

Exclusion criteria

• Non-ongoing pregnancy
• Gestation obtained by artificial insemination
• Naturally obtained gestation, without ART
• Multiple pregnancy
• Pregnancies complicated by major fetal abnormality identified at the first-trimester ultrasound
• Age <18 years
• Poor understanding of the Spanish or English languages
• Refusal in informed consent to participate in the study
• Participation in another intervention study that could modify follow-up