Fetal, Obstetrics and Reproduction Genomics

NCT05720169 | Unknown

• 1 other identifier: 0001
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preeclampsia; Intrauterine Growth Restriction; Placental Disease

Keywords

Preeclampsia; Intrauterine Growth Restriction; Genomics

Outcome Measures

Primary Outcomes (2)

• Number of Participants with preeclampsia (PE) during pregnancy

  Defined as systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg with an interval of at least 4 h after 20 weeks' gestation plus any of the following: (i) proteinuria (\>300 mg/24 h) or a urine protein/creatinine ratio \> 0.3 mg/mmol); (ii) end-organ dysfunction: systolic blood pressure \> 160 mmHg, diastolic blood pressure \>110 mmHg, platelet count \<100x109/L, blood alanine and aspartate transaminases \>70 IU/L, serum creatinine \>1. 1 mg/dL, lactate dehydrogenase \>700 IU/L, right upper quadrant or epigastric pain, dyspnea and/or cerebral/visual disturbances. Or (iii) utero-placental dysfunction (estimated fetal weight \<3rd centile or \<10th centile with abnormal uterine or umbilical Doppler \[pulsatility index \>95th centile\]) as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP) with minor adaptations for study purposes.

  ≥20 weeks to <37 weeks of gestation

• Number of fetuses diagnosed with intrauterine growth restriction (IUGR) during pregnancy

  IUGR will be defined by the following criteria: Estimated fetal weight (EFW) between percentile (p) 3 and p 10 with Doppler alteration (uterine arteries \> p 95 or cerebroplacental index \< p 5, or middle cerebral artery \< p 5, or umbilical artery \> p 95). PFE \< p 3 independently of feto-maternal Doppler.

  ≥20 weeks to <37 weeks of gestation

Secondary Outcomes (5)

• Number of fetuses and newborns with severe perinatal morbidity

  From birth up to 7 days of life

• Cesarean section rate

  During birth

• Number of Participants with pregnancy-related maternal morbidity

  From conception up to 4 days after birth

• Maternal experience and psychological impact

  From conception up to 4 days after birth

• Maternal anxiety and psychological impact

  From conception up to 4 days after birth

Interventions

Doppler ultrasound DIAGNOSTIC_TEST

Doppler ultrasound at 13, 16, 20 and 26 weeks for assessment of uterine arteries according to ISUOG criteria.

Blood sample DIAGNOSTIC_TEST

Blood sampling at 13, 16, 20, 26 weeks of gestation to determine the sFlt-1/PlGF ratio

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample 1. Virgen del Rocío Hospital Area: according to the data obtained from the pregnant women who start the pregnancy process in the Andalusian Congenital Anomalies Screening Program (PACAC) in 2021, we expect a total population of 165 pregnant women per year with age at the start of pregnancy equal to or greater than 40 years, and whose pregnancy was obtained through IVF or ovodonation. 2. Clínicas Ginemed: according to the data obtained from the report of Ginemed Clinics for the year 2021, we expect a total population of 150 pregnant women per year with an age at the onset of pregnancy equal to or greater than 40 years old, and whose gestation was obtained through IVF or ovodonation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Ginemed: lead
• Hospitales Universitarios Virgen del Rocío: collaborator
• University of Seville: collaborator
• Clínicas Ginemed: collaborator
• FIRST - Fetal, IVF and Reproduction Simulation Training Center: collaborator

Related Publications (45)

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MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Placenta Diseases

Interventions

Ultrasonography, Doppler; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Guillermo Antiñolo Gil, PhD, MD

CONTACT

0034955012772; gantinolo@us.es

Lutgardo García-Díaz, PhD, MD

CONTACT

0034955012772; lgarcia14@us.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 9, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share