An observational study in Preeclampsia, Intrauterine Growth Restriction and Placental Disease, sponsored by Fundación Ginemed. Not yet recruiting. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Fundación Ginemed · Observational
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.
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 400 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →This is the only study on the registry with Fundación Ginemed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Doppler ultrasound at 13, 16, 20 and 26 weeks for assessment of uterine arteries according to ISUOG criteria.
Blood sampling at 13, 16, 20, 26 weeks of gestation to determine the sFlt-1/PlGF ratio
Blood sampling at week 13 for DNA extraction for genomic studies
Fetal morphological ultrasound at 13, 16 and 20 weeks.
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.
Time frame: ≥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.
Time frame: ≥20 weeks to <37 weeks of gestation
Number of fetuses and newborns with severe perinatal morbidity
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.
Time frame: From birth up to 7 days of life
Cesarean section rate
Type of delivery and cesarean section rate will be recorded.
Time frame: During birth
Number of Participants with pregnancy-related maternal morbidity
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,
Time frame: From conception up to 4 days after birth
Maternal experience and psychological impact
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.
Time frame: From conception up to 4 days after birth
Maternal anxiety and psychological impact
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.
Time frame: From conception up to 4 days after birth
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2023; primary completion for Dec 2024, 14 months later.
Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 14 months is below that.
Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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