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Fetal, Obstetrics and Reproduction Genomics (FORgenomics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05720169
Recruitment Status : Not yet recruiting
First Posted : February 9, 2023
Last Update Posted : September 14, 2023
Sponsor:
Collaborators:
Hospitales Universitarios Virgen del Rocío
University of Seville
Clínicas Ginemed
FIRST - Fetal, IVF and Reproduction Simulation Training Center
Information provided by (Responsible Party):
Fundación Ginemed

Tracking Information
First Submitted Date January 29, 2023
First Posted Date February 9, 2023
Last Update Posted Date September 14, 2023
Estimated Study Start Date October 1, 2023
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 7, 2023)
  • Number of Participants with preeclampsia (PE) during pregnancy [ Time Frame: ≥20 weeks to <37 weeks of gestation ]
    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.
  • Number of fetuses diagnosed with intrauterine growth restriction (IUGR) during pregnancy [ Time Frame: ≥20 weeks to <37 weeks of gestation ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 7, 2023)
  • Number of fetuses and newborns with severe perinatal morbidity [ Time Frame: From birth up to 7 days of life ]
    Defined by a composite including any of the following: premature placental abruption, severe fetal growth restriction (birth weight <3rd centile), perinatal mortality, an Apgar score at 5'< 7.0, arterial pH less than 7.10, need for respiratory support within 72 hours of birth, neonatal intraventricular hemorrhage grade III/IV, necrotizing, periventricular leukomalacia, sepsis, bronchopulmonary dysplasia or encephalopathy due to hypoxic ischemic enterocolitis. Days of admission to ICU.
  • Cesarean section rate [ Time Frame: During birth ]
    Type of delivery and cesarean section rate will be recorded.
  • Number of Participants with pregnancy-related maternal morbidity [ Time Frame: From conception up to 4 days after birth ]
    defined by a composite including any of the following: (i) HELLP syndrome (lactate dehydrogenase [LDH] >700 IU/L, AST at twice normal values, and platelet count <100x109/L); (ii) central nervous system dysfunction (eclampsia, Glasgow Coma Score <13, stroke, reversible ischemic neurologic deficit, or cortical blindness); (iii) hepatic dysfunction (INR >1. 2 in the absence of disseminated intravascular coagulation, MELD score >10, or hepatic hematoma or rupture); (iv) renal dysfunction (dialysis, serum creatinine concentration greater than 150 μmol/L, or diuresis <0.5 mL/kg/h for 12 hours, according to renal failure by RIFLE criteria; or need for furosemide treatment to maintain diuresis >0. 5 mL/kg/h for 3 hours); (v) respiratory dysfunction (pulmonary edema, need for invasive or noninvasive mechanical ventilation, need for oxygen concentration greater than 50% for more than 1 hour, or severe respiratory distress [without pulmonary edema criteria but with presence of dyspnea,
  • Maternal experience and psychological impact [ Time Frame: From conception up to 4 days after birth ]
    It will be assessed by: - WHO Five Well-Being Index (WHO), Spanish version of 1998, applied at week 26. A brief self-assessment questionnaire on a person's perception of well-being over a specific period of time.
  • Maternal anxiety and psychological impact [ Time Frame: From conception up to 4 days after birth ]
    It will be assessed by: - Spielberger State-Trait Anxiety Questionnaire (STAI), in its Spanish adaptation applied in the 26th week of gestation. One of the first instruments validated in Spain and one of the most widely used by many researchers, it comprises two differentiated self-assessment scales: State Anxiety (SA), referring to a transitory anxious state that a person may feel in specific situations; and Trait Anxiety (RA), which characterizes a more or less stable anxious tendency that distinguishes people in their tendency to perceive situations as threatening.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fetal, Obstetrics and Reproduction Genomics
Official Title Fetal, Obstetrics and Reproduction Genomics
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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Preeclampsia
  • Intrauterine Growth Restriction
  • Placental Disease
Intervention
  • Diagnostic Test: Doppler ultrasound
    Doppler ultrasound at 13, 16, 20 and 26 weeks for assessment of uterine arteries according to ISUOG criteria.
  • Diagnostic Test: Blood sample
    Blood sampling at 13, 16, 20, 26 weeks of gestation to determine the sFlt-1/PlGF ratio
  • Diagnostic Test: Blood sample
    Blood sampling at week 13 for DNA extraction for genomic studies
  • Diagnostic Test: Doppler ultrasound
    Fetal morphological ultrasound at 13, 16 and 20 weeks.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 7, 2023)		 400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Guillermo Antiñolo Gil, PhD, MD 0034955012772 gantinolo@us.es
Contact: Lutgardo García-Díaz, PhD, MD 0034955012772 lgarcia14@us.es
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05720169
Other Study ID Numbers 0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Fundación Ginemed
Original Responsible Party Same as current
Current Study Sponsor Fundación Ginemed
Original Study Sponsor Same as current
Collaborators
  • Hospitales Universitarios Virgen del Rocío
  • University of Seville
  • Clínicas Ginemed
  • FIRST - Fetal, IVF and Reproduction Simulation Training Center
Investigators Not Provided
PRS Account Fundación Ginemed
Verification Date September 2023