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. (OMEGAROP 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Prematurity; Retinopathy
• Intervention / Treatment: Biological: Maternal blood sampling; Biological: Umbilical cord blood sampling; Biological: Placenta sampling; Other: Data collection

• Study Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: Catherine CREUZOT-GARCHER; Phone Number: 03.80.29.51.73; Email: catherine.creuzot-garcher@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourogne
    • Contact: Chloé Carré; Email: ccarre34@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women giving birth at term or prematurely

Description

Inclusion Criteria:

1. Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.
2. Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.
3. ≥18 years
4. Mothers not under legal protection

Exclusion Criteria:

1. Mothers giving birth between 29WA and 38WA+6 days
2. Mothers in critical condition.
3. Person not affiliated to national health insurance
4. 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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women giving birth prematurely; Delivery before 29 WA	Biological: Maternal blood sampling; 5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols; Biological: Umbilical cord blood sampling; 0.5mL sample from the umbilical cord after childbirth standard protocols; Biological: Placenta sampling; Sampling of 3 cotyledons by cutting across the thickness of the placenta; Other: Data collection; Newborn, Maternal and Premature Retinopathy Screening Data Collection
Women giving birth at term; Childbirth between 39WA and 31WA+6 days	Biological: Maternal blood sampling; 5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols; Biological: Umbilical cord blood sampling; 0.5mL sample from the umbilical cord after childbirth standard protocols; Biological: Placenta sampling; Sampling of 3 cotyledons by cutting across the thickness of the placenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery	16 weeks maximum after birth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Eye Diseases; Premature Birth; Retinal Diseases; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Blood Specimen Collection; Data Collection; Cordocentesis
• Other Study ID Numbers: CREUZOT-GARCHER 2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No