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.

NCT04819893 | Recruiting

• 1 other identifier: CREUZOT-GARCHER 2020-1
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prematurity; Retinopathy

Outcome Measures

Primary Outcomes (1)

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

  16 weeks maximum after birth

Study Arms (2)

Women giving birth prematurely

Delivery before 29 WA

Biological: Maternal blood sampling; Biological: Umbilical cord blood sampling; Biological: Placenta sampling; Other: Data collection

Women giving birth at term

Childbirth between 39WA and 31WA+6 days

Biological: Maternal blood sampling; Biological: Umbilical cord blood sampling; Biological: Placenta sampling

Interventions

Maternal blood sampling BIOLOGICAL

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

Women giving birth at term; Women giving birth prematurely

Umbilical cord blood sampling BIOLOGICAL

0.5mL sample from the umbilical cord after childbirth standard protocols

Women giving birth at term; Women giving birth prematurely

Placenta sampling BIOLOGICAL

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

Women giving birth at term; Women giving birth prematurely

Data collection OTHER

Newborn, Maternal and Premature Retinopathy Screening Data Collection

Women giving birth prematurely

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women giving birth at term or prematurely

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

Related Publications (1)

• Carre C, Acar N, Daruich A, Gregoire S, Martine L, Buteau B, Aho S, Eid P, Arnould L, Bron AM, Driessen M, Kermorvant E, Simon E, Creuzot-Garcher C, Gabrielle PH. Study protocol of OmegaROP-2 prospective study: expression of placental fatty acid receptors in preterm newborns with retinopathy of prematurity. BMC Ophthalmol. 2023 Oct 6;23(1):404. doi: 10.1186/s12886-023-03156-0.

  PMID: 37803473 DERIVED

MeSH Terms

Conditions

Premature Birth; Retinal Diseases

Interventions

Cordocentesis; Data Collection

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Catherine CREUZOT-GARCHER

CONTACT

03.80.29.51.73; catherine.creuzot-garcher@chu-dijon.fr

Study Design

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

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: April 20, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)