Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.

Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.

≥18 years

Mothers not under legal protection

Disqualifiers

Mothers giving birth between 29WA and 38WA+6 days

Mothers in critical condition.

Person not affiliated to national health insurance

For full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).

Trial population

Women giving birth at term or prematurely

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Maternal blood sampling

    Biological/Vaccine

    5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols

  • Umbilical cord blood sampling

    Biological/Vaccine

    0.5mL sample from the umbilical cord after childbirth standard protocols

  • Placenta sampling

    Biological/Vaccine

    Sampling of 3 cotyledons by cutting across the thickness of the placenta

  • Data collection

    Other intervention

    Newborn, Maternal and Premature Retinopathy Screening Data Collection

Treatment groups

135 Participants
are divided into 2 treatment groups
Group A: Women giving birth prematurely4 interventions
Group B: Women giving birth at term3 interventions

Trial outcomes

Primary outcomes

1

Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery

Time frame
16 weeks maximum after birth

Secondary outcomes

Other outcomes

Sponsors and contacts

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